https://CAREERS.PLANET-PHARMA.COM/ en-us
The incumbent will work cross-functionally with colleagues in the BSMO/CMSC, Regulatory, Quality and R&D on the design of processes and technologies required to produce aseptic and/or low bioburden drug products to successfully commercialize an exciting and diverse portfolio of innovative pipeline programs. In addition, the successful candidate will support the implementation of risk-based design and controls for low bioburden process operations for production of drug substance/intermediates for manufacturing. The successful candidate will be experienced in the field of aseptic process technologies (drug product and drug substance) including simulations, filter integrity, microbial testing strategies, microorganism characterization, aseptic technique and clean room facility monitoring programs.

Key Responsibilities:
 

• Provide technical input into environmental/facility/process monitoring program deviations and contamination events to determine impact to batch disposition and design/implement effective corrective and preventative actions to prevent future disruptions.
• Strong collaboration in the resolution of manufacturing investigations related to aseptic control events
• Support the design and implementation of risk-based approaches and strategies designed to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites.
• Support of regulatory submissions and pre-approval inspection activities related to contamination control and prevention and control strategies for aseptic operations.
• Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.
• Establish processes and capabilities to provide technical stewardship of control strategies post-approval including establishing performance monitoring capability and troubleshooting/ out of conformance event resolution. This will involve partnering closely with external contract manufacturing and testing organizations to establish processes to monitor test process performance and continuous improvement initiatives.
• Adherence to the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations. Drive operational excellence, flawless execution and continuous improvement.

Minimal Requirements:

• At least 10+ years of experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products, and demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.
• Deep understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and drug product manufacturing regulations and excellent written and verbal communication skills.  Prior experience supporting drug product manufacturing activities across multiple modalities (e.g., sterile dosage form, devices, etc.) and design of sterility assurance and facility monitoring programs is desired.   
• Experience with root cause analysis and deviation management
• A proven ability to work seamlessly across teams and develop excellent relationship and partnerships with peers is critical to success in this role.
• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations.
• Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations
• Strong knowledge of cGMP requirements
• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide
• Excellent team player and be able to build and sustain organization respect and trust at all levels
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them
• Resilient and able to work well in a demanding, fast paced entrepreneurial environment
• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve
• Keeps current on professional knowledge, expertise and best practice; influential in the external environment in the area of aseptic processing and participates in industry consortia/ conferences relevant to the field.

Preferred Requirements:

• Advanced degree (PhD or equivalent) in biological (microbiology preference) and/or engineering disciplines with minimally 8 years of relevant experience in biotech or pharmaceutical industries, ideally in a technical leadership role in a cGMP facility

Pay ranges between 75-85/hr based on experience  ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 • Develops and implements Training systems by identifying basic training needs, researching training options, and recommending most effective methods.
• Maintains and enhances Quality systems by identifying, isolating, and resolving problems with existing processes, using customer feedback and automated systems.
• Communicates certification and training needs by reporting gaps in manufacturing personnel training and knowledge.
• Recommends solutions to close the gaps.
• Introduces Training system upgrades by identifying and implementing more efficient
• Troubleshoot automated systems by identifying & researching the problem, making changes to the system or contacting the appropriate group to initiate a change.
• Plans and organizes project assignments of substantial variety and complexity.
• Initiates or maintains schedule for projects and project milestones.
• Establishes priorities of project assignments.
• Solves complex problems requiring extensive interpretation of procedures and practices to provide leadership in evolving projects.
• Selects methods and practices to solve problems using ingenuity, creativity, and a high degree of independent action and initiative.
• Proposes solutions independently; makes decisions on projects.
• Develops and implements projects from concept to completion.
• Process and file training records.
• Provide and proctor training.

• Create and improve training manuals
• Create and run reports.

Required Qualifications
• High School Diploma/GED or an equivalent combination of education and work experience.
• 3-5 years of related work experience.
• Utilizes/interprets advanced data to present documentation and analysis and resolve complex problems. Will perform this job in a quality system environment.
• Performs extremely complex or specialized assignments usually in the nature of projects, requiring working independently.
• Proficient in MS Excel, Word, PowerPoint, Access, SharePoint.
• Tech-savvy with experience in facilitating training programs is advantageous.
• Strong communication skills.
• Excellent organizational skills.

Preferred Qualifications
• Associate degree or completion of relevant college coursework preferred.
• Demonstrated experience working with Learning Management System (LMS)
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, Lists, and Power Apps (including Power Automate).
• Prior experience working in a medical or healthcare related company

This position is NonExempt. Hours over 40 will be paid at Time and a Half.

Pay ranges between 35-29/hr based on expereince ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 We are seeking a detail-oriented and experienced Senior Accounts Payable Analyst with proficiency in the Korean language to manage end-to-end accounts payable operations. The ideal candidate will ensure accurate and timely invoice processing, vendor management, compliance with local regulations, and support financial reporting while maintaining strong internal controls.


This is a 6-month contract position based in San Diego, with flexibility for hybrid work
Key Responsibilities

• Process and review vendor invoices for accuracy, coding, and compliance with company policies
• Communicate with vendors regarding invoice discrepancies, payment status, and inquiries in both Korean and English
• Prepare and process weekly and monthly payments
• Reconcile accounts payable transactions and resolve variances
• Maintain accurate and organized AP records and documentation
• Assist with month-end close activities related to accounts payable
• Collaborate with internal teams such as Procurement, Finance, and Accounting
• Ensure adherence to internal controls and accounting best practices

Required Qualifications

• Fluent in written and spoken Korean and English
• Strong written and verbal communication skills in both languages
• Prior experience in Accounts Payable or general accounting
• High attention to detail and strong organizational skills
• Ability to meet deadlines and manage multiple priorities
• Proficiency with accounting systems and Microsoft Excel

Ability to work independently in a remote or hybrid environment

Pay $40-50/hr based on experience 
]]> Mon, 13 Apr 2026 00:00:00 EDT 0 • Provide on-site technical support to participants during scheduled visits
• Assist participants with porting their mobile phones to the required platform
• Configure and pair Apple Watch devices with participant mobile phones
• Ensure proper installation of required applications and system settings
• Verify device connectivity, data synchronization, and functionality
• Troubleshoot basic technical issues related to mobile devices and wearables
• Provide clear instructions and guidance to participants on device use
• Document setup completion and any technical issues encountered
• Maintain compliance with data privacy, security, and study protocols

Education and Experience:
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’) or equivalent combination of education, training, & experience.
• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:
• Experience supporting clinical research or healthcare technology environments
• Familiarity with mobile device management (MDM) systems
• Experience working in participant-facing or customer support roles
• Ability to communicate information effectively
• Ability to troubleshoot and resolve issues on mobile phones and watches
• Strong customer service skills
• Ability to multi-task and pay close attention to detail
• Analytical and problem-solving skills
Pay Rate Range: $29.70 - $33.00/hr depending on experience ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 Full-time l 12 month contract

A global life sciences organisation is delivering a large scale, high visibility transformation programme and is seeking an experienced PMO Lead to act as the central engine behind governance, executive communication and programme rhythm.

This is a hands on leadership role for someone who thrives in complex environments, brings strong executive presence and is comfortable operating as the right hand to senior leadership. The position is full time, onsite, and critical to programme success.

The role

As PMO Lead, you will own how the programme operates, communicates and makes decisions. Your focus is not administration, but clarity, momentum and follow through.

You will

• Own executive and steering committee materials, shaping storyline, messaging and decision quality
• Design and run governance forums including SteerCo, sponsor meetings and leadership cadences
• Establish a clear operating rhythm with disciplined agendas, pre reads, decision logs and action tracking
• Maintain a single, consistent programme narrative across all stakeholders
• Translate complex, multi workstream activity into simple, compelling messages for large audiences
• Act as trusted advisor to the Project Executive, anticipating risks, preparing for difficult discussions and ensuring decisions are executed

Leadership scope

You will build and lead a small PMO support team, setting standards and ways of working that improve outcomes rather than creating overhead.

This includes

• Leading and developing project coordinators or assistants as scale requires
• Standardising meeting preparation, updates and planning routines
• Creating a high performing support function that enables senior leaders to focus on decisions, not logistics

What you bring

This role requires senior level judgement, confidence and the ability to influence without authority.

Key requirements include

• Extensive experience leading PMO or transformation offices within large, complex programmes
• Background in top tier consulting and or enterprise scale transformation environments
• Proven exposure to senior executives, boards or steering committees
• Exceptional executive communication skills, particularly structured storytelling and high quality deck creation
• Strong stakeholder management with the confidence to challenge constructively
• Calm, composed approach under pressure and ambiguity

Education and background

• Bachelor’s degree required; advanced degree preferred
• Formal programme or project management training is advantageous
• High level proficiency in PowerPoint and collaboration tools

]]> Mon, 13 Apr 2026 00:00:00 EDT 1
Purpose:
The QC Scientist I Raw Materials will be responsible for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality. This role will work closely with the assay transfer technical lead.  This role will mentor junior analysts and develop and facilitate training initiatives within the labs.
Essential Job Responsibilities:

• Develop/author/revise technical reports and laboratory procedures (SOPs, methods)
• Execute and troubleshoot raw material testing in support of production activities
• Perform routine release sampling and managing testing of raw materials, such as compendial analysis per USP, Ph.Eur., and JP monographs and general chapters, based on cGMP and internal procedures
• Design and perform testing in support of method transfer/validation/qualification/verification
• Review/authorize data and perform analysis and interpretation of test results and trends
• Design and/or participate in method development; equipment qualification/validation studies; deviation and OOS investigations
• Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
• Support and mentor junior team members
• Collaborate with other network sites to share best practices
• Other duties as required

 
Quantitative Dimensions:
The QC Scientist I Raw Materials will be accountable for executing and troubleshooting a variety of laboratory test methods, defining the requirements for implementation of procedures, processes and assays within QC, and identifying and implementing continuous improvement initiatives related to overall laboratory functionality.
 
Organizational Context:
The QC Scientist I Raw Materials will typically report to the Senior Manager, Quality Control Raw Materials.  This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Gene Therapies and the organization
Qualifications
Required:

• B.S. degree in chemistry, biological sciences or related field with 6+ years or M.S. degree with 4+ years of relevant experience in a GMP Quality Control role
• Prior laboratory hands-on experience with a variety of techniques such as FTIR, Raman, Near-IR, HPLC analysis and other compendial assays
• Technical knowledge and experience in relevant areas of 21CFR, ICH, USP, Ph. Eur. and FDA guidance documents as well as cGXPs in support of clinical and commercial manufacturing
• Proven knowledge in cGMP raw material program (RM sampling plans and testing requirements)
• Ensures inspection, testing and release timelines are met.
• Strong understanding of data integrity requirements and regulatory requirements pertaining to biotechnology and pharmaceutical industries and proven experience analyzing experimental data
• Experience using LIMS as an end user; Excellent technical writing and verbal communication skills
• Must be capable of observing and adhering to lab safety standards and procedures
• Successfully performs work independently with minimal instructions
• Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment, strong knowledge of GMP, SOPs and quality control processes, and strong knowledge of quality systems and regulatory requirements
• Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
• Highly self-motivated and goal oriented
• Will support and demonstrate quality standards to ensure data of highest quality and works closely with team and other functional key stakeholders on the Operations team to execute work and will be expected to perform other duties and/or special projects as assigned

Preferred:

• Experience in a Biotech/Pharmaceutical company with a high growth, fast-paced environment
• Experience in qualification of analytical equipment, including those with computerized systems
• Experience in method validation/qualification/verification/transfer

Working Conditions:

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
• This is an on-site role working in a cGMP regulated manufacturing facility.

]]> Mon, 13 Apr 2026 00:00:00 EDT 1

A leading healthcare solutions organisation is seeking an Account Manager to drive growth of its Medication Delivery Solutions portfolio across the South of the Netherlands. This role combines clinical credibility with commercial ownership and plays a key part in building long term partnerships with hospital customers.

You will act as the trusted point of contact for medication delivery solutions, managing accounts day to day while identifying, developing and converting new opportunities. Success in this role comes from strong relationships, clinical understanding and disciplined sales execution.

The role

You will own performance across your territory, ensuring both commercial growth and high customer satisfaction.

Key responsibilities include

• Acting as single point of contact for hospital customers across the medication delivery portfolio
• Owning day to day account management and coordinating internal teams to ensure smooth execution
• Ensuring implementation of solutions in line with customer needs in close collaboration with medical and clinical colleagues
• Mapping decision makers and influencers within hospitals and care settings
• Building long term partnerships through structured account planning and strong CRM discipline
• Leading cross functional customer success teams to drive adoption and satisfaction
• Driving upsell and cross sell opportunities within existing accounts
• Identifying, developing and converting new business opportunities
• Collaborating with business development on market shaping and growth initiatives
• Delivering agreed sales growth, profit and performance objectives within the region

Your background

This role suits someone who can operate confidently at the intersection of clinical environments and commercial conversations.

Key requirements include

• Nursing background with sales experience, or strong medical device sales experience with clinical credibility
• Operating room experience is essential, with exposure to medication delivery or infusion related products a strong advantage
• Proven experience in a customer facing role within the medical device industry
• Demonstrated solution selling capability with cross functional selling experience
• Comfortable working within a large, international matrix organisation
• Strong business insight with a hands on, execution focused mindset

Skills and approach

• Ability to understand customer needs and translate them into practical, value driven solutions
• Confidence engaging clinical, pharmacy and procurement stakeholders
• Structured, proactive and accountable in managing pipeline and territory performance
• Strong communication skills with the ability to build trust and long term partnerships

Education and languages

• Bachelor’s degree or equivalent experience in healthcare, business or a related field
• Native level Dutch with good English, written and spoken

]]> Mon, 13 Apr 2026 00:00:00 EDT 1 Job Description

• Daily production of Lava embolic subassemblies and final product.
• Other duties as assigned

Qualifications

• High school diploma/GED required.
• Must be detail oriented, highly accurate, conscientious and able to work independently.
• Excellent communication and interpersonal skills
• Multitasking and time-management skills with the ability to prioritize.
• Positive attitude and willingness to serve our internal and external customers.

 

Additional information

TRAINING REQUIREMENTS:

• Undergo all formal Training Events as may be directed from time-to-time.
• Observe and comply with all internal Corporate Policies.
• Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
• Work within, and ensure adherence to Health, Safety and Environment Management System procedures, instructions and other requirements.

Pay Rate Range: $20-25/hr depending on experience 
]]> Mon, 13 Apr 2026 00:00:00 EDT 0 *depending on experience

Brief Description:

The R&D Project Planner role works closely with and under the direction of Project Management Leads (PMLs) or R&D PMs, providing day to day project planning to support the timely execution of specific project goals and objectives and to maintain accurate reporting information. 

Essential Functions
•    The Project Planner supports the PML or R&D PM:
o    Generating and updating accurate day to day project plans under the direction of the PML, requiring interaction with Functional Matrix Teams (FMTs) to understand their activities, their interdependencies across the project.
o    Gathering updates from FMTs to monitor and reporting progress to the agreed plan, with particular awareness and focus on critical path activities, alerting the PML and R&D PM promptly to facilitate resolution.
o    Creating and maintaining standard Gantt views for team review, following the R&D PM conventions.
o    Generating scenario options ahead of project team meetings, sometimes at short notice and on occasion live in group settings.
o    Presenting and providing detailed planning project knowledge in working meetings, advising teams of interdependencies and in particular impact on the critical path to key milestones
o    Ensuring with the PML, that Planisware (the official corporate planning system) is maintained accurately to support downstream Portfolio Reporting and Divisional resource forecasting
•    Serves as the Planisware scheduling ‘super user’ for the R&D Project Management Team
o    Provides professional planning direct input and support for multiple Project Teams
o    Interacts with the Business Support Organisation (BSO) to maintain Planisware compliance and to facilitate system updates, improvements and user training.

Required Knowledge, Skills, and Abilities
•    Team player
•    Experience using Planisware for project planning purposes
•    Ability to collaborate cross-functionally, leveraging appropriate company tools
•    Curious and inquisitive mind with confidence to ask questions and seek clarifications
•    Excellent technical aptitude and computer software skills
•    Aptitude for working with computer systems
•    Previous experience or Interest in the drug development process and Project Management
•    Working knowledge and ideally a track record of using planning applications e.g. Microsoft Project, Planisware, etc.
•    Attention to detail
•    Problem solver
•    Excellent written and verbal communications skills

Required/Preferred Education and Licenses
•    Bachelor in science degree or equivalent ideally in a life sciences, mathematics, or engineering discipline
•    Project Management Professional Qualification (e.g. PMP, PRINCE2, etc) a plus

 ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 The Opportunity:
We are seeking an experienced Software Test & Verification Engineer to join our agile Software Development Team within thee Pathology Lab R&D in Tucson, AZ USA. This role will be vital in designing, developing, and executing comprehensive test strategies and test cases to ensure software quality.

Key Skills & Experience Required
--You have a minimum of 4 years progressive experience in software development and testing.
--You have a strong understanding and experience with software testing methodologies (black-box, white-box, functional, non-functional, regression, integration, system, acceptance).
--You are adept in at least one object-oriented programming or scripting language used for test automation (e.g., Python, Java, C#).
--You possess excellent problem-solving skills with meticulous attention to detail. Excellent written and verbal communication skills, with the ability to convey technical information effectively to both technical and non-technical audiences.

Additional Skills & Experience
--You have experience with industry-standard test automation tools and frameworks (e.g., PlayWright, Selenium, Appium, Cypress, JUnit, TestNG).
--You are proficient using CI/CD tools and test management tools and processes (e.g., Jira, HP ALM, Jenkins, GitLab CI, Azure DevOps).
--You have experience using AI tools to perform automated test planning, development, execution, analysis, and reporting.
--You have proven experience in mentoring and training junior team members.

Education:
--You have a Bachelor's degree in a related technical field (e.g., Computer Science, Software Engineering, Electrical Engineering, etc.).

Pay ranges bwteen 50-75/hr based on experience 
]]> Mon, 13 Apr 2026 00:00:00 EDT 1 ?Essential Functions/Responsibilities
??Collaborate with BPOs, SMEs and relevant stakeholders to create or revise
process?documents
? Promote continuous process improvement across R&D, in alignment with best
practices and?regulations
??Provide process expertise and document guidance to R&D BPOs across multiple
functional?areas
??Support the integration of process documents
??Support BPOs with timely completion of process document periodic reviews
??Create process maps using Microsoft Visio, as applicable
? Support the development of training materials and quizzes as required
??Promote the use of R&D BPO networks to ensure a consistent approach to
process?development
? Support ongoing inspection or audit readiness activities
? Perform the role of training coordinator if necessary for applicable process
documents.
? Lead or contribute to authoring and implementation of change controls in EDMS
related to procedural documentation, as applicable
?

?Required Knowledge, Skills, and Abilities

??Self-motivated and achievement-oriented, with the ability to operate in a
changing?environment
??Excellent understanding of processes within Biopharmaceutical
R&Dorganization
??Demonstrated success in authoring process documents or functioning as a
business process?owner (preferred)
??Strong negotiation skills, routinely demonstrated in a cross-functional setting
??Strong networking skills, with the ability to facilitate, collaborate with cross-
functional teams such as?Pharmacovigilance, Global Regulatory Affairs, and
Clinical Operations
??Demonstrated track record of driving process improvement activities
??GxP knowledge
??Strong attention to detail, along with excellent written and verbal communication
skills
??Strong ability to implement a systematic approach to problem solving and
prioritize tasks to?meet deadlines
??Maintain a continuous process improvement mindset
??Strong EDMS experience
??Proficient in Microsoft Office, including Visio
?Required/Preferred Education and Licenses
??Bachelor’s degree with 5 years of experience in a scientific, clinical, process
improvement, or?similar role (required)
]]> Mon, 13 Apr 2026 00:00:00 EDT 1
Job Purpose
Keep assigned lines supplied with bulk products and components. Perform various filling and packaging operations.

Major Accountabilities
• Supplies production line with product and packaging components as required.
• Loads and unloads components or product onto or from pallets, trays, racks, shelves and machines manually.
• Load components on machines and monitors operations to detect malfunctions.
• Attaches pumps and hoses into hopper connections as required.
• Assures all perimeter shippers are labeled prior to leaving the production floor.
• Scrapes hoppers, assures hoppers stay filled during production run.
• Assist with cleaning equipment as needed for efficient and proper line clearance.
• Transfers materials and/or products to or from storage or work sites to designated area by manual or power floor jack, dolly or other device.
• Assemble shippers, removes trash, product waste from packaging area.
• Cleans and sanitizes work areas using broom, wipes, mop, or cleaning machine, (i.e. gowning area, packaging floor perimeter and fill rooms).
• Weighs or counts product for disposal, documents weight and disposes accordingly.
• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency.
• Maintain effective communication between shifts.
• Perform Packaging Pharma Operator duties as necessary.
• Maintains supply of PPE (i.e. gloves, sleeves, dust masks) isopropyl alcohol (IPA) and wipes on packaging lines.
• Work with equipment such as ladders, manual floor jack, dollies, and be able to service multiple packaging lines simultaneously.
• Alerts Supervision, Mechanics and Quality personnel of safety, quality and equipment performance problems when they occur.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee must be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

Key Performance Indicators
• Solid English reading/comprehension written and verbal communication skills required to understand and communicate to others detailed cGMPs, SOP's, FI’s, and production equipment cleaning instructions.
• Basic mathematical skills and ability to work with numbers to accurately count components, waste and finished goods products.
• Support and implement safety initiatives, wearing all personal protective equipment (PPE), and displaying safe work performance according to company standards.
• Perform key roles in a manner that motivates personnel, promotes teamwork, is respectful of others while remaining aligned with company’s behaviour expectations.
• Takes initiative and works autonomously to meet production requirements.
• Continues to develop and learn new skills, which will allow for further advancement within the organization.

Job Dimensions
Number of associates:
0
Impact on the organization: Medium

Ideal Background
Education: • High School Diploma or GED. Associates Degree preferred. Equivalent experience can be considered in lieu of HS Diploma
• Minimum of one year production experience
Experience: • Ability to lift 50 lbs. and maintain a high level of physical activity]]> Mon, 13 Apr 2026 00:00:00 EDT 1

A global healthcare technology organisation is advancing its medication management strategy to improve safety, efficiency and connectivity across hospital and pharmacy environments. To support this transformation, a Solution Specialist IT is being hired to work across Belgium with regular engagement in the Netherlands.

This is a field based, pre sales focused role centred on designing integrated medication management solutions and enabling connectivity across complex healthcare IT landscapes.

Role overview

You will work with hospitals during the pre sales phase to analyse existing IT and pharmacy environments and define how medication management solutions should be integrated. Acting as the technical lead, you will engage directly with hospital IT, pharmacy and clinical teams to translate workflow and system requirements into robust solution designs.

The role is primarily Belgium based with approximately thirty percent travel to the Netherlands. Candidates can be based in central or northern Belgium provided travel is straightforward.

Key responsibilities

• Assessing customer hospital, pharmacy and IT environments to define integration approaches
• Leading technical pre sales discussions with IT, pharmacy and clinical stakeholders
• Designing solution architectures aligned with medication management workflows and cybersecurity requirements
• Explaining interoperability options across HIS, EHR and pharmacy systems using HL7, FHIR, XML and REST APIs
• Participating in customer workshops, demonstrations and technical deep dive sessions
• Supporting tender responses through technical documentation, diagrams and integration descriptions
• Collaborating with sales, customer success, marketing, R&D and product management teams
• Contributing to data driven value discussions including efficiency, safety and return on investment

Your background

• Around five years experience in hospital connectivity and integrated healthcare IT
• Hands on architecture experience using HL7, FHIR, XML and REST based integrations
• Strong understanding of networking fundamentals and cybersecurity concepts
• Proven ability to operate in a pre sales or customer facing technical role
• Comfortable leading complex technical discussions with both technical and non technical audiences

Education and languages

• Degree in IT, Computer Science, Biomedical Engineering, Pharmacy IT or a related field
• Fluency in Dutch or French with good command of English

]]> Mon, 13 Apr 2026 00:00:00 EDT 1

Lead end-to-end implementation, configuration, and integration of Thermo Fisher SampleManager LIMS

Gather existing laboratory and shop-floor workflows; translate them into digital processes

Coordinate interfaces between LIMS and laboratory systems.

Drive CSV activities: author URS, execute IQ/OQ/PQ protocols, and other deliverables.

Provide on-site deployment and hypercare support for go-live

Collaborate with cross-functional stakeholders to ensure user adoption Requirements:

• Minimum of Bachelors Degree in STEM field.
• Experience working with Thermo SampleManager LIMS and GMP environments.
• Proven track record implementing and validating enterprise applications.
• Solid experience integrating LIMS with slaboratory systems.
• Hands-on expertise in CSV (Computer System Validation) and GMP compliance.
• Strong stakeholder management skills.

 ]]> Mon, 13 Apr 2026 00:00:00 EDT 1
To perform the duties associated with labeling, inspecting, and packaging of vaccines. Responsible for operating packaging equipment ensuring target line rates are met. Collaborates effectively with other functional groups to ensure production goals are achieved and completed in a timely manner

• Operation of packaging equipment (e.g.: labelers, pick and place, heat tunnel, vision systems, forklift, etc.)
• Inspect product accurately and efficiently to meet quality guidelines.
• Perform equipment change-over, set-up.
• Responsible for initial troubleshooting for packaging equipment issues (e.g. Labelers, Pick and place, heat tunnel, etc.)
• Ensure that proper cGMP documentation is follow for completeness and adherence to our procedures and in a timely manner.
• Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
• Preparation of QA Line clearances (e.g. Small volume line)
• Maintains a safe, clean and organized work environment.
• Maintains facilities and equipment as required by Standard Operating Procedures.
• Cross-training in other areas within the department as require to meet business needs.
• Other duties as assigned by the Shift Line Leader or Supervisor.

Communication
• Communicates processing needs to co-workers.
• Communicates progress several times a day to the shift line leader and/or Supervisor.
• Communicates at the time of event any process occurrences to shift line leader and/or Supervisor (escalation process).
• Communicates facility and inventory related needs daily.

Assessment
• Monitors process against manufacturing records, data capture forms and Standard Operating Procedures.
• Participates in Daily Performance Review (Team).

Systems
• Completes batch tickets with materials consumed during execution.
• Provides feedback as to feasibility of improvement proposed by others.
• Adheres to defined process sequences.

Ability to demonstrate a commitment to the HSE Program. Work in a safe and responsible manner. Supports safety policies and procedures. Identifies and properly reports unsafe work habits, conditions, and/or practices.
 ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 Summary:
Dedicated to evolving the practice of medicine and helping patients to live longer, better lives. Our operations are critical to the success of our company and our impact on society, doing now what patients need next.

The individual in this role will be responsible for all aspects of various projects of a less complex nature:
--Interfaces with all areas affected or supporting the project.
--Responsible for assembling project time, assigning individual responsibilities, identifying appropriate resources needed, and developing schedule to ensure timely completion of
project.
--Monitors projects from initiation through delivery including monitoring budget/spending.

Responsibilities:
Production (80%)
? Manages project team information to support project team, LCT and/or LCC decision making
? Accountable for quality implementation on projects in the following areas: Project risk management, Critical path analysis, Scenario creation and analysis, Budget, Robust planning
? Ability to identify and communicate issues proactively to a wide range of stakeholders
? Creates, coordinates and maintains integrated project plans in Project & Portfolio Mgmt. Tool (PPM)
? Identifies gaps, potential bottlenecks or delays, challenges assumptions and proposes options to close gaps and get projects back on schedule
? Manages preparation for project milestone reviews
? Manages meetings to include setting agendas, organizing meeting time and meeting minutes
? Executes project management processes
? Follows best practices in project teams and fosters continuous improvement by sharing knowledge and continuous exchange
? Performs other duties as assigned
? Other duties as assigned by management

Teamwork and Collaboration (10%)
? Effectively communicates projects status and potential cross-functional impacts within the portfolio to the team and extended leadership
? Communicates effectively with interdepartmental teams and external vendors/customers
? Effectively communicates with all key stakeholders when problems are suspected or become evident
? Proactively elevates concerns to Manager with all necessary details to ensure leadership is well-informed of the issue, the likely ramifications, and the recommended solution(s)
? Participates in staff meetings
? Effectively collaborates cross-functionally with technical teams to support product launches
? Acts as a backup for other project manager team members to ensure no gaps in project execution and tracking

Continuous Improvement (5%)
? Leverage technology tools to deliver project solutions to improve productivity, reduce costs and simplify processes
? Proficient in lean tools required by organizational leadership for area
? Evaluates group processes and executes process simplification as required
? Operates with a lean mindset

Safety and Quality (5%)
? Operates with a safety and quality mindset
? Completes all training in a timely manner to meet compliance requirements
? Maintains quality system compliance (e.g., follow processes and procedures as written)
? Maintains current process information and documentation per internal and external guidelines
? Participation in internal or external audits and regulatory inspections as requested
? Proficient with current PLM systems

Education/Experience:
? Bachelor’s degree plus
? 2 years project management, product development and/or relevant experience (Preferred)
? Project Management specific training and/or certification (Preferred)

Knowledge Skills and Abilities:
? Excellent verbal, written and interpersonal communication skills
? Ability to partner and collaborate to work cross-functionally
? Situational assessment and decision-making skills
? Problem solving skills and ability to coordinate project related activities
? Ability to manage projects with activity/milestone achievement to launch the product/project
? Understanding of relevant Design Control and/or Phased Development processes preferred
? Proficient in MS Project and/or Project & Portfolio Management Tool
? Experience with Google Suite of products

Pay ranges bwteen 34-36/hr based on experience 
]]> Mon, 13 Apr 2026 00:00:00 EDT 1
RESPONSIBILITIES:
• Operation and maintenance of the Screening Instrument and initial review of test results for donor specimens and QC samples
• Testing performed with refractometers and pH meters.
• Knowledge of screening and specimen validity test methods: EIA, CEDIA, ELISA, refractometers and pH meter
• Troubleshoot issues with screening instruments
• Adherence to all security procedures for ensuring confidentiality of donor information
• Adherence to all established guidelines outlined in theEmployee Handbook

BASIC QUALIFICATIONS | EDUCATION:
• BS degree in Chemistry or Biology

PREFERRED QUALIFICATIONS:
• Advanced ability to understand analytical techniques and procedures
• Advanced ability to understand laboratory instrumentation
• Advanced ability to understand certification requirements for SAMHSA, CAP-FDT, and other relevant regulatory bodies.
• Advanced ability to understand the function of a Laboratory Information System (LIS) and other laboratory computer systems

COMPETENCIES:
• Ability to lift and/or move 25 pounds
• Ability to have full body movement
• Must have vision and hearing corrected to meet minimum acceptable norms
• Math and reasoning ability to develop and communicate laboratory procedures and reports
• Ability to cope with stress due to production obligations
• Ability to read and comprehend the SOP, Federal (49 CFR Part 40), and CAP-FDT guidelines
• Ability to communicate with other employees and supervisors
• Ability to provide input and recommendations on operations
• May be potential exposure to toxic or hazardous materials

The max pay rate is 19/hr]]> Mon, 13 Apr 2026 00:00:00 EDT 1 *depending on experience

Independently plays a key role in maintenance, troubleshooting and repair in all aspects relative to good maintenance practices of equipment, reliability and performance of systems such as clean utilities, clean room HVAC, power plant/utilities and HPW systems.

Skills:
Experience: Training and/or hands on in, Boilers and plant steam systems
Compressed air systems, Centrifugal chillers and cooling towers, Process chill water systems, RO/DI, HPW systems, Clean steam systems, Generators and electrical systems.

Education: 
?High School Diploma +5 years’ experience in a manufacturing environment preferably in a pharmaceutical industry.
Associates Degree/Technical Degree in a relevant field of study +2 years experience in a manufacturing environment, preferably in a pharmaceutical industry.
Knowledge of and adherence to EHS requirements.
Intermediate level problem solving/troubleshooting.
Proficient verbal and written communication]]> Mon, 13 Apr 2026 00:00:00 EDT 1 We’re supporting a global biopharma organisation seeking an experienced Clinical Research Associate to join their growing team across Belgium or the Netherlands. This is a permanent position offering broad involvement across the full study lifecycle — not only monitoring.
The Role
In this position, you will take full ownership of your assigned protocols, typically working on one study at a time. Responsibilities include:

• Start-up activities and contract negotiation
• Site initiation and ongoing monitoring
• Site relationship management and issue resolution
• Close-out activities
• Working across approximately 6–8 visits monthly (flexibly managed)
• Contributing to high?quality delivery across early?phase oncology studies

The organisation empowers CRAs to manage their protocols end?to?end rather than being billed out for isolated monitoring-only responsibilities.
Experience Required

• CRA experience at CRA I or CRA II level
• Oncology background
• Phase I experience preferred but not essential
• For Netherlands–based CRAs: Dutch and English, French is a plus
• For Belgium–based CRAs: French, English and Dutch

Location

• Remote across Belgium or the Netherlands, with travel between both countries as needed
• Office-based options available if preferred

]]> Mon, 13 Apr 2026 00:00:00 EDT 1 We are seeking a Senior Technical Consultant with deep expertise in microbiology, sterile manufacturing and GMP quality systems to support pharmaceutical clients across complex global operations. This is a senior, highly visible role working directly with manufacturing, QA and leadership teams to solve technical challenges, drive compliance, and support continuous improvement across regulated environments.

The role blends scientific expertise, quality leadership and strong customer?facing capability. You will support commercial teams with technical insight, lead investigations, participate in audits, deliver training, and manage multiple client projects simultaneously. This is a hands?on position involving on?site cleanroom work, contamination control reviews and active engagement during regulatory inspections.
What You’ll Do

• Provide expert microbiology and GMP guidance to pharmaceutical manufacturing clients, supporting root?cause investigations, CAPAs, change controls and contamination?related issues.
• Conduct on?site cleanroom audits, sterility and hygiene assessments, and support regulatory inspection readiness.
• Lead and support multiple projects simultaneously, working closely with Quality, Operations and cross?functional stakeholders.
• Deliver technical training, webinars and customer presentations (in?person and virtual), including large audiences.
• Support technical sales colleagues by providing scientific expertise during customer discussions.
• Review contamination?control strategies, support disinfectant efficacy discussions and advise on regulatory requirements.
• Engage in data?driven analysis and translate findings into clear recommendations for clients.
• Participate in internal onboarding and skills development to expand technical capability within the team.

What You Bring

• Degree in Microbiology (BSc required; MSc strongly preferred).
• Minimum 7+ years’ experience in GMP pharmaceutical manufacturing (medicinal products, not medical devices).
• Significant experience in sterile/aseptic operations and cleanroom production environments.
• Hands?on involvement in internal audits, investigations, change management, quality assurance and CAPAs.
• Experience being audited by external regulatory bodies (FDA, EMA or local authorities).
• Strong knowledge of contamination control, aseptic processing and disinfectant efficacy concepts.
• Comfortable presenting to large audiences (100+ in person; 500+ via webinar).
• Fluent English required; strong preference for German speakers.
• Ability to manage multiple projects, communicate with senior stakeholders and challenge when required to uphold compliance.
• Willingness to travel internationally up to 50%.

]]> Mon, 13 Apr 2026 00:00:00 EDT 1

Position Summary

The purpose of the Analyst I, Quality Control (Non-Clinical) is to perform analytical testing to

support the release of Non-Clinical grade rAAV vector lots manufactured in various departments (including, Pre-Clinical Manufacturing, Process Development, MSAT) and external

partners. The rAAV vectors tested/characterized by the team will support capsid technology

development, intellectual property portfolio, and internal progression of early-stage gene therapy

programs.

Job Responsibilities

· Perform routine and complex execution of molecular biology and biochemistry analytical

methods such as qPCR, d/ddPCR, ELISA, HPLC, endotoxin etc.

· Organize and perform data analysis at completion of each test method, peer review data.

· Assist with evaluation of analytical results and final reports.

· Follow SOPs and document analytical test method procedures.

· Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory

notebook analytical records.

· Contribute to technical discussions and investigations.

· Assist with management of raw materials, analytical test method supplies, and samples

as needed.

· Ensure lab areas are clean, organized and equipment, supplies and raw materials are

available for use.

Minimum Requirements

· Bachelor’s degree in biology or related field.

Preferred Education, Experience and Skills

· Relevant work experience (0-2 years) in areas such as, analytical testing, development,

and technology transfer; in rAAV/gene therapy, recombinant protein/biomolecules, and/or

other advanced therapeutic modalities.

· Experience with electronic laboratory notebooks is a plus.
]]> Mon, 13 Apr 2026 00:00:00 EDT 1 We are seeking an Automation Engineer to manage and maintain factory automation systems, ensuring reliable operations, optimized processes, and accurate real-time data for decision-making. This role includes implementing new automation projects, troubleshooting, preventive maintenance, and lifecycle management across production systems.
Key Responsibilities
Automation Systems & Operations

• 
  Implement, maintain, and troubleshoot automation, process control, and supervision systems (PLCs, SCADA/HMI, MES, historians, industrial networks).
  
• 
  Support preventive and corrective maintenance to maximize system uptime and reliability.
  
• 
  Manage lifecycle of automation assets, including obsolescence planning, backups, and disaster recovery procedures.
  

Process Improvement & Technology

• 
  Evaluate and implement new technologies to enhance automation capabilities and production efficiency.
  
• 
  Standardize systems and reduce complexity to ensure traceability, data integrity, and operational continuity.
  

Compliance & Cybersecurity

• 
  Ensure automation systems comply with regulatory, quality, and cybersecurity standards.
  
• 
  Support operational audits, validation, and documentation of automation systems.
  

Collaboration & Stakeholder Support

• 
  Partner with production, quality, IT, and engineering teams to implement automation initiatives.
  
• 
  Train operators and maintenance staff on system usage and best practices.
  

Qualifications
Education

• 
  Bachelor’s degree in Automation, Electrical, Electronics, Control Systems, or IT-related field.
  

Experience

• 
  1+ year in automation, control systems, or industrial IT environments.
  
• 
  Experience with regulated manufacturing or international projects is a plus.
  

Technical Skills

• 
  PLCs, controllers, sensors, and industrial networks (Ethernet/IP, Fieldbus)
  
• 
  SCADA/HMI, MES, BMS/EMS, and OPC UA server integration
  
• 
  IT fundamentals: servers, databases, OS, and remote access
  
• 
  Cybersecurity concepts (network zoning, firewalls, access control, backups)
  

Soft Skills

• 
  Strong problem-solving and analytical thinking
  
• 
  Teamwork, communication, and stakeholder collaboration
  
• 
  Proactive mindset, ownership, and resilience
  

Languages

• 
  Japanese: professional proficiency
  
• 
  English: advanced proficiency desirable
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Mon, 13 Apr 2026 00:00:00 EDT 1 Unlock Your Potential as an Associate Director, Global Regulatory Strategy

Are you a strategic thinker with a passion for shaping global regulatory pathways in the pharmaceutical industry? Join a dynamic team at the forefront of neurology and beyond, where your expertise will drive impactful regulatory strategies across international markets. This role offers the opportunity to collaborate with senior stakeholders, influence industry initiatives, and lead initiatives across a range of neurological indications, including insomnia, narcolepsy, and epilepsy. If you’re ready to make a meaningful difference in a fast-paced environment and bring innovative ideas to life, this is your chance to thrive in a pivotal leadership position.

Required Skills

• Exceptional communication skills, both written and verbal, demonstrated through clear, impactful responses and comprehensive coveragesheets
• Proven experience in development and/or established product regulatory processes
• Experience leading health authority meetings, particularly with EMA or other global agencies
• Strong understanding of MAA and CTA processes
• Ability to work independently and provide strategic input within a collaborative team setting
• Flexibility to engage with international regulatory activities and a variety of product indications
• Demonstrated responsiveness and agility in communication and issue resolution

Nice to Have Skills

• Background in neurology or specialty therapeutic areas
• Experience working on US or Rest of World regulatory strategies
• Proven track record of representing organizations at industry conferences and initiatives
• Familiarity with CMC and labeling considerations (though not a primary focus)
• Exposure to cross-functional collaboration spanning clinical development and regulatory affairs

Preferred Education and Experience

• Bachelor’s degree in Life Sciences, Pharmacy, or related discipline; Advanced degree preferred
• Minimum of 8+ years in regulatory affairs, with leadership experience in global or regional teams
• Demonstrated success in leading regulatory submissions and interactions with health authorities
• Prior involvement in neurology or related therapeutic areas is advantageous

Other Requirements

• Ability to work in a hybrid environment, with approximately 3 days per week on-site 
• Willingness to engage in industry initiatives and represent the organization at conferences
• Proactive approach to stakeholder engagement and strategic planning
• Eligibility to work internationally and travel as needed for global meetings and conferences

Take the next step in your regulatory career and become a key driver of innovation and leadership in a globally influential organization. If you possess the expertise and drive to excel in this role, we encourage you to apply now and join a visionary team shaping the future of neurology and beyond.
]]> Mon, 13 Apr 2026 00:00:00 EDT 1 Overview:
The Commercial Data Enablement team within IT is seeking a consultant to support the management, documentation, data lineage tracking and delivery of data-driven initiatives supporting Commercial Effectiveness, Market Access and Marketing teams. The consultant will report to the Associate Director, Commercial Data Enablement, and collaborate closely with IT, business stakeholders, and the change advisory board to ensure commercial KPIs, business requirements, and project deliverables are accurately defined, documented, and implemented.

Key Responsibilities:

· Partner with Commercial Effectiveness, Market Access, and IT stakeholders to document business requirements for data and analytics initiatives.

· Facilitate requirement walkthroughs, impact assessments, and coordination across IT, business, and vendor teams.

· Leverage data expertise to depict data lineage for business rules using Snowflake and to brainstorm using data flow charts.

· Maintain and update KPI documentation, ensuring alignment across data sources, definitions, and reporting tools.

· Ensure documentation and requirements are properly stored, version-controlled, and accessible in Confluence.

· Perform quality assurance checks and execute validation of data across Snowflake, SQL Server, and BI environments.

· Perform UAT testing ensuring business requirements are met to serve stakeholder needs and to help deliver patient outcomes.

· Support project lifecycle activities, including requirements review, sign-off, and successful UAT completion.

· Drive consistent processes for change control, release validation, and stakeholder communication.

Required Skills & Experience:

· Excellent communication, stakeholder management, and cross-functional collaboration skills with ability to own and follow through on initiatives assigned.

· Demonstrated ability to coordinate business and IT teams through requirement gathering and UAT execution.

· Strong understanding of commercial data environments, including Specialty Pharmacy (SP), Claims, Specialty Distributor (SD), and HUB data.

· Hands-on experience with linking data sets using (Snowflake) and SQL.

· Familiarity with commercial data concepts (Rx claims, patient journey).

· Proficiency with JIRA and Confluence for project tracking and documentation.

Preferred Qualifications:

· Experience with BI tools (Qlik, Tableau, Power BI) for KPI visualization and Agentic AI for driving autonomous commercial workflows.

· Experience in Marketing Analytics and Salesforce Marketing Cloud (SFMC).

· Exposure to global commercial and medical affairs teams (e.g., US, Europe, Japan).

· Understanding of data cataloging, metadata management, or data quality frameworks.

Education

Bachelors degree in computer, marketing or life sciences majors. Masters preferred.

Skills and Experience

The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.
Pay Range: $80-85/hr *based on experience ]]> Mon, 13 Apr 2026 00:00:00 EDT 1 CMC Technical Writer – MSAT (Contract)
? US Remote or Hybrid
? 3–6 Month Contract
 
About the Role
We are seeking a highly experienced CMC Technical Writer to serve as the primary author for global regulatory submissions supporting commercial pharmaceutical products. This is a high?impact, senior individual contributor role with full ownership of complex CMC content across global markets.

The ideal candidate brings deep expertise in CMC documentation, strong scientific and manufacturing understanding, and proven success writing for FDA, EMA, and other major health authorities. This role offers full autonomy, cross?functional visibility, and the opportunity to influence regulatory success across a global supply network.

---

Why This Role Is a Great Opportunity

• Act as the primary CMC author for global submissions on commercial and late?stage assets
• Highly autonomous role with no people?management responsibilities
• Significant impact on regulatory strategy, submission quality, and inspection readiness
• Broad cross?functional exposure (MSAT, Regulatory, Quality, CMOs)
• Remote?friendly position supporting global product lifecycle activities

---

Key Responsibilities CMC Technical Writing & Documentation

• Independently author and revise complex CMC sections for global regulatory submissions, including original applications, supplements, variations, and technical responses.
• Translate MSAT, manufacturing, and CMO data into clear, accurate, regulator?ready content.
• Ensure documentation accurately reflects process understanding, control strategies, and commercial manufacturing activities.

MSAT Collaboration & Technical Alignment

• Partner with MSAT SMEs to capture, structure, and articulate detailed product and process knowledge.
• Maintain consistency across internal technical documentation and global regulatory filings.
• Serve as a documentation authority, advising on structure, detail, and clarity.

Global Regulatory CMC Support

• Provide hands?on authorship for global submissions (FDA, EMA, international agencies).
• Prepare and refine technically complex responses to health authority questions.
• Support inspection preparation through high?quality, inspection?facing documents.

Lifecycle & Change Management Support

• Manage CMC documentation updates to support post?approval changes.
• Ensure global consistency across historical and current filings.
• Support documentation for change controls, deviations, investigations, and process changes.

External Partner / CMO Collaboration

• Work directly with CMOs to obtain and integrate technical information.
• Support onboarding of new manufacturing partners with accurate documentation capture.

Quality, Compliance & Independence

• Deliver inspection?ready, compliant submissions aligned with ICH, GMP, and global CMC guidelines.
• Apply and refine templates, style guides, and documentation standards.
• Operate independently, managing timelines and priorities with minimal oversight.

---

Top Required Skills

• 15–20 years of experience in CMC documentation, regulatory writing, MSAT, or technical operations
• Extensive authorship of CMC sections for FDA, EMA, and global submissions
• Advanced degree (MS/PhD) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
• Deep understanding of drug substance/drug product manufacturing, control strategies, and lifecycle management
• Expert knowledge of ICH guidelines, GMP expectations, and global CMC requirements

---

Preferred Qualifications

• Experience supporting multi?regional submissions and post?approval changes
• Background in process chemistry or pharmaceutical development
• Proven success preparing documentation used during regulatory inspections
• Experience as a documentation authority within MSAT or Technical Operations

---

Key Competencies

• Expert?level technical writing and editing
• Ability to independently synthesize complex scientific information
• Strong judgment and attention to detail in a regulated environment
• Effective communication across technical and non?technical teams
• Ability to manage multiple complex documents and timelines autonomously

---

Location & Travel

• US Remote, or Hybrid (PA)
• Up to 5–10% travel to domestic or international manufacturing sites

]]> Mon, 13 Apr 2026 00:00:00 EDT 0 Join Our Team as a Clinical Supply Operations (CSO) Technician based in Merseyside and Play a Vital Role in Advancing Clinical Research

Are you detail-oriented with a passion for quality in a fast-paced GMP environment? We are seeking a dedicated and organized Clinical Supply Operations (CSO) Technician to support critical packaging activities within our dynamic clinical operations team. This operational role offers the opportunity to contribute to groundbreaking clinical trials, ensuring the safe and accurate packaging of investigational medicinal products.

What You'll Do:

• Execute start-up, routine, and completion activities for clinical trial packaging in accordance with SOPs, GMP standards, and EHS guidelines.
• Perform primary packaging tasks such as bottle filling of oral dosage forms, and assemble and label supplies including syringes, vials, and wallets using automated and manual equipment.
• Maintain accurate electronic batch records, equipment logbooks, and documentation throughout all production stages.
• Monitor and control production processes, troubleshoot equipment issues, and escalate concerns as needed to ensure consistent quality.
• Collaborate with team members and operate independently to meet daily production targets.
• Participate in internal audits and contribute to continuous process improvements, always prioritizing safety, quality, and customer service.

Required Skills:

• Prior experience in GMP packaging and labelling, preferably within clinical trial environments.
• Familiarity with electronic systems such as SAP.
• Proven ability to follow SOPs, GMP practices, and health and safety requirements.
• High attention to detail and accuracy.
• Strong problem-solving, communication, and teamwork skills.
• Computer literacy and willingness to learn and share knowledge.

Nice to Have Skills:

• Clinical trial packaging experience.
• Experience with automated labelling and walleting equipment.
• Knowledge of clinical trial operations beyond packaging.

Preferred Education and Experience:

• A-levels or equivalent, preferably in sciences or IT-related subjects.
• Prior experience in a GMP environment with exposure to clinical packaging operations.

Other Requirements:

• This is a full-time, on-site role based in Merseyside 
• Ability to work safely, adhere to COSHH regulations, and participate in internal audits.
• The position is initially contracted for 12 months, with potential for extension.

If you're eager to make a meaningful impact in clinical research through meticulous and compliant packaging operations, we encourage you to apply now. Take the next step in your career and join a team committed to excellence and innovation in healthcare.
]]> Mon, 13 Apr 2026 00:00:00 EDT 1 Job Title: Business Analyst
Employment Type: Permanent, Full-Time
Location: Tokyo (office-based)

Role Overview
This is an excellent opportunity for a highly analytical, data-driven graduate or early-career professional to join a business analysis team within the pharmaceutical industry.

The role offers:

• Exposure to senior leadership early in your career
• Responsibility for client-facing project delivery
• Structured development and training from an experienced analyst team
• The chance to build both quantitative and qualitative analytical capability

You will work in a close-knit team environment and be encouraged to contribute ideas, insights, and new perspectives.

Key Responsibilities

• Managing multiple client projects and timelines to meet internal and external deadlines
• Working closely with Project Leaders and other analysts to interpret data and develop recommendations
• Analysing data from multiple sources using quantitative and qualitative approaches
• Reviewing and pressure-testing data to identify trends, risks, and areas for further investigation
• Building and maintaining Excel-based databases from source data
• Producing high-quality presentations and client deliverables in PowerPoint
• Supporting team members to meet deadlines and drive efficiency across local and international projects

Essential Requirements

• Degree in Economics or a science-based discipline with strong numerical content (e.g. Chemistry, Physics, Mathematics, Engineering)
• A few years’ experience in a similar analysis, consulting, or sales support role within the pharmaceutical industry is advantageous
• Strong communication skills with the ability to manage multiple stakeholders and priorities
• Advanced proficiency in Excel and PowerPoint
• Proactive, driven individual with ambition and a strong work ethic, looking to grow within a fast-paced and evolving environment

]]> Sun, 12 Apr 2026 00:00:00 EDT 1 Contribute to the safe and efficient operation of pharmaceutical manufacturing processes, ensuring high-quality production, adherence to standards, and continuous improvement. Provide technical guidance, support local projects, and help maintain a reliable, compliant manufacturing environment.
Key Responsibilities

• 
  Operate assigned production, testing, or analysis areas according to established procedures and meet requirements for safety, quality, hygiene, cost, and delivery.
  
• 
  Investigate and resolve abnormalities or deviations, implementing corrective actions in line with procedures and SOPs.
  
• 
  Prepare and maintain GMP-related documentation for production and quality management.
  
• 
  Regularly review, update, and draft SOPs for assigned areas.
  
• 
  Maintain equipment, inventory, and workplace cleanliness.
  
• 
  Support business process improvements and participate in continuous improvement initiatives.
  
• 
  Provide technical guidance and mentorship to junior team members.
  
• 
  Participate in local projects, providing expertise and support as needed.
  

Qualifications & Experience

• 
  High school graduate or equivalent; hands-on experience in solid pharmaceutical manufacturing is essential.
  
• 
  3+ years of experience in pharmaceutical manufacturing or related production environment (slightly less may be acceptable with strong skills).
  
• 
  Strong knowledge of pharmaceutical manufacturing processes, control standards, and GMP requirements.
  
• 
  Excellent interpersonal and communication skills.
  
• 
  Japanese: Native or fluent; English communication is not required.
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Top 3 technical  skills that are required for the role:

1. Experience with ERP systems – SAP

2. Experience with EUMDR

3. Experience with change control in Medical Device Quality System

 Education Required:

• Bachelors Degree in Engineering discipline and at least 2 years of relevant experience providing direct manufacturing process support, OR
• Masters’ Degree and less than 2 years of relevant experience in a manufacturing environment providing direct manufacturing process support.

Years’ Experience Required: 2 years of relevant experience providing direct manufacturing process support


 

Provides shop floor support for manufacturing methods and processes in machining, metal finishing and assembly operations for assigned product lines.  Maintains Manufacturing Process Planning documentation and insures the accuracy of labor standards.  Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.

 

• Completes activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with the company Corporate CAPA system.
• Completes activities of Lean Sigma projects and process improvements.
• Provides technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems.
• Proactively execute and support development of validation/qualifications studies.  Determine strategy with appropriate teams and ensure that groups are involved early on in the needs of the engineering group.
• Responsible for the investigation of change requests received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes.
• Working with the appropriate groups; maintains manufacturing process sheets for all machining, assembly, and finishing operations.
• Makes appropriate changes in manufacturing methods, processes and Manufacturing Process Planning documentation when dictated by engineering drawing changes. Documents all changes through the appropriate change control system.
• Coordinates entry of all master data for assigned product lines. This may include Purchase Requests, Capital Appropriation Request, Inventory Approval Forms, Material Masters, Bills of Material, routings, production versions, work centers, and document information records.
• Coordinates update of production order data as needed
• Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.  
• Performs other duties as assigned.

 
Requirements:

• Working knowledge of industry standards and regulatory requirements (including but not limited to: ISO 13485, ISO 14971, MDD 93/42 EEC, PAL, CMDR, and 21 CFR Part 820). Understands impact of compliance to the requirements and how it relates to their job, or is aware of resources available to them to assist with determining impact.
• Strong communication skills, both oral and written
• Good interpersonal skills
• Ability to work in a fast paced environment
• Ability to work well under pressure and maintain positive, enthusiastic attitude
• Eagerness to learn and expand responsibilities
• Ability to work effectively in a team environment and build strong working relationships.
• Willingness to participate in continuous improvement activities

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Support quality assurance activities for manufactured products, ensuring compliance with regulations, proper documentation, and smooth product release. Maintain and improve systems for record keeping, product standards, and regulatory notifications.
Key Responsibilities

• 
  Maintain and operate systems for manufacturing records and product standards, ensuring accurate documentation and proper usage.
  
• 
  Review production and quality testing records to ensure compliance and product integrity.
  
• 
  Coordinate with internal departments and subcontractors to promote smooth workflow and record management.
  
• 
  Oversee product shipment processes, including inspection schedule adjustments and cross-department coordination.
  
• 
  Prepare and submit required notification documents for regulatory authorities promptly.
  

Qualifications

• 
  University degree in Chemistry, Pharmacy, Biology, or a related natural science.
  
• 
  Experience in quality assurance within a regulated manufacturing environment (GMP/GQP).
  
• 
  Japanese: Native or business-level proficiency; English: Business-level proficiency.
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Join Our Team as an Outbound Sales Specialist – South France

Are you a passionate sales professional with a hunter's mindset and a flair for building lasting relationships? Do you thrive in dynamic environments where your drive and strategic approach can make a real impact? We’re seeking an Outbound Sales Specialist to spearhead our growth in the vibrant South France region. This is your chance to be part of a trusted, innovative company and help expand our footprint across European veterinary markets.

In this role, you will leverage your outbound calling expertise to reconnect with existing clients and engage new prospects, primarily through phone and video conferencing. Your mission is to cultivate strong, long-term relationships with veterinary clinics, turning one-time buyers into loyal, multi-year clients. With your proactive approach, you will identify new opportunities within your region, develop a healthy sales pipeline, and contribute meaningfully to our expanding European presence.

Required Skills:

• 3+ years of outbound sales experience, ideally within veterinary, healthcare, or related sectors
• Proven ability to generate and nurture leads, with a focus on building long-term relationships
• Strong negotiation and influence skills
• Excellent communication skills in French and English (fluency in local language essential)
• Ability to manage and prioritize a busy sales pipeline
• Knowledge of relevant medical or veterinary terminology (or willingness to learn)
• Self-motivated, confident, and results-oriented mindset

Nice to Have Skills:

• Experience selling into veterinary clinics or medical environments
• Familiarity with CRM tools and pipeline management
• Understanding of industry trends, competitors, and the veterinary market landscape
• Additional language skills beyond French and English

Preferred Education and Experience:

• Degree or diploma in business, sales, health sciences, or related field
• 3-5 years of direct outbound sales experience, with a track record of achieving or exceeding targets
• Experience working in multicultural or international environments

Other Requirements:

• Must be based in South France, excluding Nancy and Nance regions
• Willingness to travel regionally within South France
• EOR (Employer of Record) status or equivalent arrangement expected; HR confirmation pending
• Valid driver’s license and ability to research and meet clients in person when necessary

Take your sales career to the next level with a company that values proactive, relationship-focused professionals. If you’re eager to contribute to a growing, reputable business while enjoying a competitive package and the opportunity to make a real difference—apply now and help us shape the future of veterinary healthcare across Europe!
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Join Our Team as an Outbound Sales Specialist - South Netherlands

Are you passionate about building relationships and driving sales in a dynamic, growth-focused environment? We are seeking a motivated and results-oriented Outbound Sales Specialist to join our expanding team in the South Netherlands region. This is an exciting opportunity to connect with veterinary clinics, cultivate long-term partnerships, and play a key role in our European expansion. If you enjoy engaging with clients, uncovering new opportunities, and making a tangible impact, this role is perfect for you.

What You'll Do:

• Conduct proactive outbound calls and virtual meetings with veterinary clinics to nurture existing relationships and identify new business opportunities.
• Engage with warm leads, including past customers and interested prospects, to build trust and promote our products.
• Manage the sales pipeline, ensuring continuous growth with the goal of establishing long-term, loyal clients.
• Collaborate closely with the UK-based sales team and support strategic initiatives to expand our presence across Europe.
• Occasionally meet clients in person, especially when requested or when the country sales manager is unavailable.
• Track activity and provide regular updates and reports to senior leadership, contributing to the overall sales strategy.

Required Skills:

• 3-5 years of outbound sales experience, preferably in veterinary, health, or related medical sectors.
• Proven success in building and maintaining long-term customer relationships.
• Hunter mentality with a passion for sales and a drive to meet or exceed targets.
• Strong communication skills in Dutch and English, with the ability to articulate technical and product information clearly.
• Excellent negotiation skills and a customer-first approach.
• Comfortable working independently, self-motivated, and proactive in managing your pipeline.
• Proficient in using CRM systems and Microsoft Office tools.

Nice to Have Skills:

• Experience within the veterinary space or familiarity with animal health products.
• Knowledge of the European veterinary industry and market trends.
• Existing network within veterinary clinics in the South Netherlands region.
• Ability to adapt quickly to new industries or technical areas with training.
• Additional language skills relevant to the region.

Preferred Education and Experience:

• Relevant sales experience in a field-based or territory management role.
• Educational background in life sciences, veterinary medicine, or related fields is advantageous but not essential.
• Demonstrated track record of achieving significant sales targets and developing client relationships over 3-5 years.

Other Requirements:

• Fluency in Dutch and English.
• Willingness to travel within the South Netherlands region for client meetings.
• Eligibility to work in the Netherlands.
• Valid driver’s license (company car allowance provided; vehicle not supplied).

Ready to take your sales career to the next level and make a difference in the animal health industry? If you thrive on building meaningful relationships and delivering results, we want to hear from you. Apply now and become a vital part of our European growth journey!
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Part Time; On Site Role
8am-5pm (Tues, Weds, Thurs)  

 Job Description:

• Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)
• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
• Verify inventory and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders.
• Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Develop timeline assessments (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
• Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
• Maintains current and active licensure and certification(s) to administer First Aid, BLS and CPR for emergent needs in healthy volunteer clinical research studies
• Support clinical research laboratory operations as needed
• Other incidental duties as assigned

Required:

• At least 2 years in a clinical role such as Emergency Medical Technician or Medical Assistant
• Current CPR and First Aid certification from an accredited provider
• Able to work 3 days per week (Tuesday, Wednesday, and Thursday), with occasional flexibility to support full work weeks as needed

Preferred experience/qualifications:

• Associate's/Bachelor’s degree in a related field 
• >1–2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.

Pay $30-32/hr]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Job Title: Associate Director / Director, Clinical Monitoring
Location: Tokyo, Japan

Overview
A global clinical research organisation is seeking an experienced Associate Director / Director of Clinical Monitoring to lead and scale its Clinical Monitoring function in Japan. This role plays a critical leadership position within the local Clinical Operations organisation, with responsibility for people leadership, resource planning, and delivery of high-quality monitoring across a broad clinical portfolio.

The organisation supports Phase I–IV clinical development programs across multiple therapeutic areas, leveraging strong scientific, regulatory, and operational expertise to deliver studies efficiently and compliantly.

Key Responsibilities

• 
  Provide direct line management and leadership to Clinical Monitoring management teams, ensuring effective performance, engagement, and development
  
• 
  Oversee CRA resourcing and allocation across studies and sites to ensure optimal coverage and delivery
  
• 
  Contribute to workforce planning, recruitment, and retention strategies for the Clinical Monitoring function in Japan
  
• 
  Ensure robust training, onboarding, and ongoing oversight of CRA Managers and monitoring teams
  
• 
  Support local and global leadership in achieving Clinical Monitoring operational metrics, KPIs, and quality objectives
  
• 
  Act as a senior operational leader within Japan, partnering cross-functionally to support study delivery and compliance
  

Candidate Profile

• 
  Bachelor’s degree with extensive experience in Clinical Monitoring within a CRO or pharmaceutical environment
  
• 
  10+ years of industry experience, including:
  
  • 
    4+ years’ hands-on experience as a CRA
    
  • 
    6+ years’ experience in CRA management or equivalent leadership roles
    
• 
  Advanced knowledge of ICH-GCP and J-GCP requirements
  
• 
  Strong people leadership skills, with a proven ability to mentor, motivate, and develop high-performing teams
  
• 
  Excellent English communication skills (written and verbal); Japanese language skills advantageous depending on background
  
• 
  Proficient in Microsoft Office and clinical operations systems
  

Travel

• 
  Up to approximately 10%
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Job Title: Regulatory Submissions Manager
Location: Osaka, Japan

Overview
A global clinical research organisation is seeking an experienced Regulatory Submissions Manager to support clinical trial start-up and regulatory submission activities in Japan. This role sits within a well-established clinical operations team and plays a key part in ensuring regulatory readiness, submission quality, and smooth study initiation across global and local clinical programs.

The organisation supports Phase I–IV clinical development programs across multiple therapeutic areas and is known for its strong regulatory expertise, structured processes, and commitment to high-quality clinical execution.

Key Responsibilities

• 
  Lead and execute regulatory start-up activities for global and local clinical studies, ensuring timelines and quality standards are met
  
• 
  Perform quality control reviews of regulatory submission packages and site essential documents
  
• 
  Prepare, review, and approve informed consent forms in line with regulatory and ethical requirements
  
• 
  Review applicable regulations and guidelines to proactively identify and resolve start-up risks or challenges
  
• 
  Contribute to bid defenses, client meetings, capability presentations, and regulatory or quality audits as required
  

Candidate Profile

• 
  Bachelor’s degree or advanced degree (Master’s or PhD) in Life Sciences or a related discipline
  
• 
  5+ years of experience in clinical research, ideally within a CRO or pharmaceutical environment
  
• 
  Background may include experience as a CRA, Project Manager, or within regulatory start-up/submissions
  
• 
  Strong understanding of regulatory submissions activities and clinical trial start-up processes
  
• 
  Solid knowledge of ICH guidelines and applicable global and local regulatory requirements
  
• 
  Demonstrated ability to organise, guide, and coordinate team activities across multiple projects
  
• 
  Strong written and verbal communication skills
  

Language Requirements

• 
  Native-level Japanese (JLPT N1)
  
• 
  Business-level English proficiency (minimum TOEIC score of ~500 or equivalent)
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Join Our Dynamic Global HR Team as an HR Assistant – Elevate Employee Experience and Make a Difference!

Are you passionate about supporting organizations through exceptional HR administration? Do you thrive in a collaborative, client-centric environment where your meticulousness and interpersonal skills shine? We’re seeking a dedicated HR Assistant to be the backbone of our global HR functions, ensuring seamless processes from onboarding to offboarding for a diverse workforce across multiple sites. This is your opportunity to contribute to a company celebrated for its innovation, caring culture, and impactful health solutions.

What You’ll Bring:

• At least 5 years of experience in HR administration, handling employee lifecycle processes with precision.
• Strong organizational skills with a keen eye for detail.
• Excellent interpersonal and communication abilities.
• Proficiency in HR tools and internal software.
• Ability to prioritize tasks effectively and manage multiple ongoing responsibilities.
• Fluent French speaking; good command of English is appreciated.

Nice to Have:

• Experience supporting HR projects or reporting activities.
• Knowledge of payroll coordination and social security procedures.
• Previous exposure to international or multi-site HR environments.

Preferred Education & Experience:

• Bachelor’s degree (Bac +3) to Master’s degree (Bac +5) in HR or related field.
• A minimum of 5 years working within HR administration roles.

Additional Requirements:

• Based in Dijon, France, with occasional travel between sites.
• Willingness to work on-site, with a flexible approach after initial six months, including two days of remote work per month.
• Commitment to diversity and inclusion in the workplace.

If you’re eager to support a thriving international company in delivering meaningful health solutions while advancing your HR career, we invite you to apply. Your expertise can help us create a positive, reliable, and inspiring employee journey—join us today!
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Join the manufacturing team to gain hands-on experience across formulation, packaging, and quality management. Support production operations, maintain equipment, ensure product quality, and contribute to process and technology improvements. This is a generalist role ideal for early-career professionals with a science or pharmacy background.
Key Responsibilities

• 
  Operate and maintain manufacturing equipment in formulation and packaging processes.
  
• 
  Support quality assurance and quality control activities, including analytical testing and documentation for raw materials, in-process materials, and finished products.
  
• 
  Contribute to process optimization, production efficiency, and formulation technology improvements.
  
• 
  Assist in the creation, revision, and maintenance of SOPs and other GMP-related documents.
  
• 
  Collaborate with cross-functional teams across production and quality departments.
  
• 
  Participate in continuous improvement and local projects as assigned.
  

Qualifications & Experience

• 
  Graduated from a four-year science program, pharmacy program (6-year), graduate school (Master’s or Doctoral), or technical college (5–7 years).
  
• 
  At least 2 years of work experience, preferably in a manufacturing or regulated environment.
  
• 
  Business-level English proficiency (TOEIC ~600 or equivalent).
  
• 
  Strong interest in pharmaceutical manufacturing and quality processes.
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Job Title: Experienced Clinical Research Associate (CRA)
Locations: Tokyo, Japan and Osaka, Japan
Headcount: 1 position per location

Overview
A global clinical research organisation is seeking experienced Clinical Research Associates to support clinical trial delivery across Japan. These roles are based in Tokyo and Osaka and will be responsible for site-level execution and oversight of clinical studies, ensuring compliance with applicable regulations, protocols, and quality standards.

The organisation supports Phase I–IV clinical development programs across a broad range of therapeutic areas and is recognised for its structured approach to clinical operations, strong regulatory compliance, and commitment to data quality.

Key Responsibilities

• 
  Conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with study protocols, SOPs, GCP, and applicable local regulations (including J-GCP)
  
• 
  Act as the primary point of contact for investigative sites, building effective relationships with investigators, study coordinators, and site staff
  
• 
  Verify investigator qualifications, training, and site resources, including facilities, laboratories, equipment, and staffing
  
• 
  Perform source data verification and ensure accurate documentation and data entry in line with protocol and regulatory requirements
  
• 
  Identify, document, and communicate protocol deviations, ensuring appropriate corrective and preventive actions are implemented
  
• 
  Conduct on-site and remote monitoring activities using a risk-based monitoring approach, including centralized data review through clinical trial systems
  
• 
  Ensure enrolment of eligible subjects only and review regulatory documentation for completeness and accuracy
  
• 
  Oversee investigational product and/or medical device accountability and inventory
  
• 
  Review adverse events, serious adverse events, and concomitant medications to ensure accurate and timely reporting
  
• 
  Evaluate site performance related to patient recruitment and retention and provide recommendations for improvement
  
• 
  Prepare high-quality monitoring reports and follow-up letters, clearly documenting findings, risks, and required actions
  

Candidate Profile

• 
  Minimum of 1 year of experience as a Clinical Research Associate within a CRO or pharmaceutical environment
  
• 
  Bachelor’s degree in a health- or science-related discipline
  
• 
  Strong understanding of ICH-GCP and J-GCP requirements
  
• 
  Native-level Japanese (JLPT N1)
  
• 
  Business-level English proficiency (minimum TOEIC score of ~500 or equivalent)
  
• 
  Willingness to travel approximately 60–80% per month across Japan
  
• 
  Proficient in Microsoft Office and clinical trial systems
  
• 
  Strong communication, presentation, and stakeholder-management skills
  
• 
  Highly detail-oriented with strong organisational and time-management abilities
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Medical Science Liaison (MSL)
Position Overview
Medical Science Liaisons (MSLs) are field-based members of the Medical Education function and act as scientific ambassadors for the organization. In this role, MSLs educate and build trusted relationships with clinicians, researchers, payers, and other healthcare professionals.

The MSL collaborates closely with internal teams including Clinical, R&D, Marketing, and Sales to support the full product lifecycle and pipeline. As the scientific expert within an assigned territory, the MSL travels regularly to provide education, scientific exchange, and clinical support to the Sales organization.

Through external engagement and subject-matter expertise, the MSL gathers and communicates medical insights from the field to inform strategic planning and execution across the organization’s portfolio of genetic testing products. The role requires strong technological aptitude and the ability to leverage scientific and digital tools appropriately to support business objectives.
Key Responsibilities

• 
  Serve as a scientific representative to clinicians, academic institutions, and professional organizations.
  
• 
  Conduct scientific exchange and collect, analyze, and communicate insights related to marketed and pipeline products.
  
• 
  Respond to unsolicited requests for medical and scientific information from healthcare professionals.
  
• 
  Act as a medical and scientific resource for internal Sales and Marketing teams.
  
• 
  Establish and maintain relationships with Key Opinion Leaders (KOLs) within oncology and other relevant healthcare communities.
  
• 
  Develop educational materials for healthcare professionals and patients, as appropriate.
  

Qualifications
Education

• 
  Master’s degree or pharmacist license required.
  

Experience

• 
  Academic or professional background in oncology preferred, particularly in colorectal or bladder cancer.
  

Knowledge, Skills, and Abilities

• 
  Native-level Japanese and business-level English proficiency.
  
• 
  Confident, outgoing, and professional presence.
  
• 
  Strong independence of thought with the ability to communicate persuasively.
  
• 
  Proven ability to build collaborative relationships with internal stakeholders (e.g., Sales, Marketing, Regulatory, R&D) and external healthcare partners.
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Senior Regulatory Affairs Specialist

Join a forward-thinking organization at the forefront of medical device innovation as a Senior Regulatory Affairs Specialist. In this pivotal role, you will navigate the complexities of regulatory landscapes across the EMEA region, ensuring compliance and facilitating successful market access for cutting-edge products. Your expertise will directly contribute to advancing healthcare solutions and improving lives worldwide.

What You’ll Bring:

• Extensive regulatory knowledge in medical devices, including experience with international standards such as ISO 13485 and directives/regulations like 93/42/EEC and 2017/745
• Proven ability to determine global regulatory pathways, classifications, and submission strategies
• Strong familiarity with the regulatory environments of the EMEA region, including Europe, Middle East, and Africa
• Excellent attention to detail, with robust procedure development and training experience
• Outstanding communication and relationship management skills
• Proficiency in managing multiple projects simultaneously with exceptional time management
• Multilingual capabilities are a plus
• Solid IT skills, including MS 365 and Excel; familiarity with platforms like Monday and Veeva is advantageous

Preferred Education & Experience:

• Bachelor's degree or higher in biological, physical, engineering, or health sciences
• At least four years of related regulatory affairs experience in the medical device sector
• Supervisory experience is a plus

Additional Requirements:

• Ability to work on-site in Maastricht, Netherlands, three days a week, with flexible remote work options for the remaining two days
• Willingness to participate in virtual and face-to-face interviews with key stakeholders
• Commitment to continuous improvement and proactive problem-solving

This is a fantastic opportunity to be part of a growing company with a broad portfolio, dedicated to innovation and excellence. With every team member’s voice valued and a clear path for career progression, you’ll have the chance to make a meaningful impact in regulatory affairs while advancing your professional journey. Take the next step and apply now to become a vital part of this dynamic team poised for exciting future projects.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1
About the Role
In today’s hybrid go-to-market environment, combining dealer-based distribution and direct customer sales, delivering outstanding support to both customers and partners is essential. Strong leadership is required to establish, standardize, and continuously enhance customer-focused processes that drive satisfaction and operational excellence.

The organization is on a transformation journey toward service excellence and aims to further strengthen and expand its Customer Care capabilities across the region.
Key Responsibilities Geographic Scope
The role will initially oversee operations in Thailand, with a phased expansion to additional countries where regional subsidiaries operate.
Functional Scope
Oversight of the full Customer Care lifecycle, from installation through end-of-life support, including:

• 
  Field Service
  
• 
  Repair Centers
  
• 
  Administrative support
  
• 
  Spare parts logistics and warehousing
  
• 
  Helpdesk operations, including Customer Service and Level 1 and Level 2 Technical Support
  

Product Scope
Support responsibilities cover imaging systems, including X-ray and camera technologies, conservative and surgical dental equipment, and related application software.
Financial Scope
Full regional P&L accountability for Customer Care operations.
Core Objectives

• 
  Lead and manage Customer Care Operations teams in assigned countries, starting with Thailand.
  
• 
  Develop and deploy structured processes and procedures to progressively improve customer satisfaction and operational efficiency.
  
• 
  Define and implement KPIs to measure performance across customer satisfaction, governance, and financial outcomes.
  

Operational Responsibilities

• 
  Oversee daily Customer Care operations in Thailand, providing clear leadership and short- to mid-term planning.
  
• 
  Guide and support Customer Care teams across regional subsidiaries.
  
• 
  Assist dealer networks with service-related matters, including technical training initiatives.
  
• 
  Take ownership of escalated issues requiring management intervention.
  
• 
  Act as a central coordination point between customers, dealers, subsidiaries, and internal stakeholders.
  
• 
  Develop mid- and long-term Customer Care strategies in collaboration with senior regional leadership.
  

Additional Responsibilities

• 
  Coordinate resolution of complex or high-visibility service cases.
  
• 
  Ensure transparent information flow regarding technical issues between dealers, subsidiaries, manufacturing sites, quality management, R&D, and product management.
  
• 
  Contribute to regional sales support activities in alignment with regional leadership.
  

Team Structure Direct Leadership
Responsible for managing the Thailand-based Customer Care organization, including:

• 
  Field Service teams
  
• 
  Repair Center operations
  
• 
  Administrative support
  
• 
  Spare parts logistics and warehousing
  
• 
  Coordination of Helpdesk functions, including Customer Service and Level 1 and Level 2 Technical Support
  

Managerial Responsibilities

• 
  Recruit, onboard, and train team members
  
• 
  Plan and supervise departmental schedules
  
• 
  Conduct performance reviews and provide structured feedback
  
• 
  Manage disciplinary actions and employment matters in line with company policies
  
• 
  Oversee departmental training programs
  
• 
  Contribute to the budgeting process
  

Indirect Leadership
Provide guidance and operational support to Customer Care teams across regional subsidiaries, working closely with local General Managers.
Key Internal Stakeholders

• 
  Regional Sales Leadership
  
• 
  General Managers of regional subsidiaries
  
• 
  Automation and technical support leadership
  
• 
  Factory repair and advanced support managers
  
• 
  Local support functions including HR, Finance and Accounting, and IT
  

Education and Experience
Education:
Bachelor’s degree in a technical discipline such as electronics, mechatronics, mechanical engineering, IT, or a related field, or equivalent professional experience.

Experience:

• 
  Minimum 5 years in a customer-facing or service organization
  
• 
  At least 1 year in a supervisory role within an international environment in the region
  
• 
  Proficiency in Microsoft Office, experience with CRM systems, and basic ERP knowledge
  

Required Skills and Competencies

• 
  Strong leadership and people management capabilities
  
• 
  Customer-focused mindset
  
• 
  Excellent interpersonal and communication skills
  
• 
  Strong organizational and planning abilities
  
• 
  Solid understanding of technical systems including hardware and software
  
• 
  Analytical thinking and effective problem-solving
  
• 
  Ability to coach, train, and develop others
  
• 
  Comfortable working both independently and within a team environment
  
• 
  Cultural awareness and sensitivity within diverse Asian markets
  

Personal Attributes

• 
  Composed under pressure, particularly in managing complex complaints
  
• 
  Self-driven with a continuous improvement mindset
  
• 
  Comfortable operating within a matrix organization
  
• 
  Willingness to travel regionally at approximately 40 percent or more
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 *Max PR: 19/hr 

Role:
The Intake Specialist role works to support the Patient Assistance Program (PAP) through providing initial triaging of patient applications, including data entry and coordination of work through the appropriate channels as determined by established business rules.

Responsibilities:
•Completes the intake process of all applications into Customer Relationship Management System (CRM)
•Associates and tags all images to the patient, data enters all information including patient demographic information, physician information, drug information, and all relevant application data such as income information, household information and insurance information into the CRM
•Conducts initial assessment of application for missing information and completes missing information patient outreach process to obtain required data
•Completes initial assessment of simplified application
•Identify appropriate work flow based upon business rules
•Collaborate cross functionally to ensure processes are followed according to business rules and policies
•Ensure all patient cases are documented in the CRM in accordance with all business rules and policies
•Conduct renewal and year end recertification’s process as determined by the Patient Assistance Program
•Readily assists on special project within job scope to improve reimbursement optimization when requested by management
Manages incoming and outgoing mail

Qualifications:
•High school diploma or equivalent required. College or a 2-year Associate Degree is preferred
•A minimum of 1-3 years’ experience within an office or administrative setting
•Exposure to core insurance (Medical and Pharmacy Benefit) knowledge a plus
•Strong attention to detail and work independently with minimal direction
•High quality customer service skills
•Ability to express ideas clearly in both written and oral communications
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Additional position details from the manager:

Can you please confirm your top 3 skills sets required? Experience running project schedules using MS Project or similar software, experience with project risk management, excellent communication

Can you please confirm the 3 main responsibilities/day to day activities required for this role? Cross-functional project schedule development and management, leading risk management activities, leading meetings and communicating across the team and project sponsors

What products (if any) will this role support? PVH released products and/or new product development

What is your target years of experience? 7-10 years

_____________________________________________________________________________________________________
 

Within our Research & Development organization in Peripheral Vascular Health, we focus on deploying project management methodologies and practices to ensure robust planning, monitoring/controlling and execution of new product development activities, continuous improvement initiatives and released product management. Our Project Management Specialists are directly involved in all stages of the project life cycle for our innovative devices and therapies.

 

In this role, the individual will work on projects that are in various phases of product development. They will be working with internal project team members as well as suppliers and business partners to develop and sustain our product portfolio. As a core team member, this individual will be responsible for defining the scope, budget, and timeline of the project, along with managing project execution within a cross-functional team. This position requires broad cross-functional knowledge and comprehensive business management skills, working closely with team members with expertise from the following disciplines: product development, clinical, regulatory affairs, quality, operations, supplier quality and product marketing.

 

A Day in the Life:

 

·         Represent the Research & Development Portfolio Operations group on teams as the PMO representative

·         Build cross functional project schedules from first principles.

·         Identify and escalate project risks and issues.

·         Lead project management activities such as project planning, tracking, risk management, and communications. 

·         Implement best practice tools and techniques in project management within projects and within PVH R&D.

·         Track and monitor project performance and progress and provide regular updates to stakeholders

·         Manage changing priorities on projects through effective schedule management and deployment of PM methodologies.

·         Keep the Team Leader and key Sponsors and Stakeholders informed of capacity constraints and portfolio risks.

·         Act as a role model by striving for continuous improvement and being an agent of change.

·         Support continuous improvement initiatives within the PMO.

 

Nice to Have

• Experience working in Technical Project Management environment

• Experience with medical device design control is desirable.

• Cross-functional team experience.
 

 Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Job Title: Business Development Manager
Location: Tokyo, Japan (office-based)
Employment Type: Permanent
Reporting Line: Operations Director Overview
An established and growing regulatory services organisation in Japan is seeking a Business Development Manager to support its continued expansion in the domestic market.

The company currently partners extensively with international pharmaceutical and biotech companies entering Japan and is now investing in strengthening its presence with Japan-based clients. This hire will play a key role in developing local business opportunities and supporting broader commercial growth.

This is a hands-on business development role. It is not a senior leadership or strategic director position. The successful candidate will actively manage pipeline activity, generate new opportunities, and support commercial expansion across Regulatory Affairs and Marketing Authorisation Holder (MAH) services.

The role suits someone commercially driven, comfortable working independently, and confident engaging with pharmaceutical and biotech stakeholders in Japan.
Key Responsibilities

• Drive day-to-day business development activity
• Identify, qualify, and pursue new business opportunities across regulatory and MAH services
• Manage inbound enquiries and generate outbound opportunities
• Build and maintain relationships with pharmaceutical and biotech clients (domestic and international)
• Prepare proposals, presentations, and commercial documentation
• Collaborate with internal Regulatory, QA, and MAH teams to scope and position services
• Track pipeline activity and maintain accurate reporting
• Support client meetings, follow-ups, and ongoing account development

Candidate Profile

• 3–7+ years’ experience in business development, sales, or commercial roles
• Background within pharma, biotech, CRO, regulatory consulting, MAH services, or related life sciences sectors
• Comfortable with hands-on execution rather than purely strategic oversight
• Strong communication skills with the ability to engage credibly with clients
• Good understanding of the Japanese pharmaceutical and regulatory landscape preferred

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Job Description: 
The Clinical Data Manager I will, at the direction of the Lead Clinical Data Managers, review data for multiple studies and perform User Acceptance Testing (UAT).
Clinical Data Manager will recommend process improvements related to their job responsibilities that can be used or developed to increase efficiency.

What will you do?
Data Review:
• At the direction of the Lead Clinical Data Manager perform regular data review across studies to identify quality issues, data trends/outliers and generate queries as necessary. Data Management Documentation:
• Participate in the updating of the Data Management Plans, Data Review Guidelines and CRF Completion Guidelines. User Acceptance Testing:
• At the direction of the Lead Clinical Programmer, perform User Acceptance Testing (UAT) of the clinical databases including EDC. Collaboration with Cross-Functional Teams:
• At the direction of the Lead Data Manager, provide ongoing day-to-day support to Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved.
• Collaborate with internal team and stakeholders to ensure deliverables meet timelines.
Process Improvement:
• Recommend process improvements related to their job responsibilities that can be used or developed to increase efficiency.

Requirements
How will you get here?
• 0-2 years of experience working in clinical data management, preferably in the pharmaceutical or medical device industry
• Multi-tasking, problem-solving and verbal and written communication skills essential
• Excellent verbal and written communication skills
• Ability to work well with others •
Bachelor's Degree BS or higher in biological science, nursing or other health-related discipline Preferred

Pay $26-34/hr based on experience ]]> Fri, 10 Apr 2026 00:00:00 EDT 1 As a Senior DevOps Engineer you will be the primary builder and operator of cloud-native Digital Pathology infrastructure. You will focus on automating the secure, scalable hosting of image management systems (VMS) and AI workloads primarily within AWS, while managing connectivity to enterprise applications in Microsoft Azure. You will own the “Infrastructure as Code” (IaC) strategy, ensuring that the massive storage requirements of Whole Slide Imaging (WSI) and the burst-compute needs of AI inference are handled with efficiency, security, and strict GxP compliance. This role acts as the bridge between on-premise scientific computing and the limitless scale of the cloud.

Responsibilities:
Design and implement secure, scalable cloud architecture on AWS (S3, EC2, Batch, Lambda) using Infrastructure as Code (IaC) tools such as Terraform or CloudFormation
Automate intelligent storage lifecycle and tiering policies (for example, S3 Intelligent-Tiering and Glacier) to manage petabyte-scale pathology image archives cost-effectively while ensuring rapid retrieval for clinical review
Build and maintain robust CI/CD pipelines (for example, Jenkins, GitHub Actions, or Azure DevOps) to automate testing and deployment of AI models, integration scripts, and application updates
Implement comprehensive observability and reliability practices using monitoring and alerting tools (CloudWatch, Datadog, Splunk) to track system health, API latency, and data pipeline performance, ensuring high availability for clinical services
Manage secure cross-cloud networking and API connectivity between the AWS data plane and Azure-based enterprise systems (such as LIMS, billing, and ESB), ensuring seamless identity management and data flow
Enforce security-by-design principles by managing IAM roles, encryption keys (KMS), and network security controls to maintain compliance with HIPAA, GDPR, and GxP standards
Manage containerized workloads using Docker and Kubernetes to support portable AI inference and microservices that scale dynamically based on lab volume
Education, Experience & Qualifications:
Bachelor’s Degree or equivalent work experience required
5 or more years of experience in DevOps or Cloud Engineering with a primary focus on AWS environments required
Previous experience managing Azure resources in Terraform preferred
Extensive experience with Infrastructure as Code (IaC), specifically Terraform (preferred) or AWS CloudFormation
Proven track record of managing hybrid cloud networking (Direct Connect/VPN) and cross-cloud integrations, including connecting AWS services to Azure AD or API Management
Experience in regulated industries (healthcare, finance, biotech) managing sensitive data (PHI/PII) is strongly preferred
Hands-on experience with container orchestration (EKS, ECS, or Kubernetes) and serverless computing
AWS mastery with deep knowledge of core services, including S3 (object locking and lifecycle), EC2 and Auto Scaling, VPC networking, IAM, and Lambda
Proficiency in Python, Bash, or Go for automation and glue code
Expertise in building CI/CD pipelines using Jenkins, GitLab CI, GitHub Actions, or Azure DevOps
Strong understanding of encryption standards (TLS, AES), secrets management (Vault or Secrets Manager), and least-privilege access control
Functional knowledge of Azure AD, Azure Functions, or Azure API Management to support integration tasks ]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Position Summary:

The Hematopathologist will be responsible for providing contemporary Hematopathology services that integrate morphological examination with Flow Cytometry, Cytogenetics, FISH and Molecular genetics. The ideal candidate will have 5 years post-fellowship experience in Hematopathology, though outstanding candidates with less than 5 years of experience may be considered.  

Core Responsibilities:

• Performs diagnostic interpretation of biopsy and/or cytology material to include gross and microscopic evaluation, dictation and electronic release of reviewed cases.
• Reads and interprets laboratory data.
• Performs quality control and assurance procedures and participates in departmental professional quality control and quality assurance activities.
• Participates in several functions involved in day-to-day operations, including case consultation sign out responsibilities with full time availability to interact with our clients for Pre-Analytical, Analytical, and Post-Analytical questions.
• Provides expertise and assistance to technologists and technicians to resolve case issues.
• Serves as Delegated Clinical Consultant when assigned by site Medical Director.
• Works closely with clinical and administrative staff to insure the highest standards of TAT, quality, and customer service are maintained
• Builds effective relationships with referring physicians and ensures excellent client follow-up.

Experience & Required Qualifications:

• M.D. or D.O. degree and board certification/eligibility in Anatomic and Clinical Pathology preferred, board certification in Hematopathology required
• At least Five (5) years of attending level experience in hematopathology is strongly encouraged
• Active or eligibility for an unrestricted Medical License in the state of FL required. Eligibility for NY, CA and TX a plus.
• Proven track record as a productive member of a multi-disciplinary team, including a demonstrated ability to work collaboratively with peers in senior management
• A proven record of obtaining required information related to identifying needs and potential solutions, analyzing or improvising the most appropriate solution, and determining and documenting the most appropriate course of action.
• Proven experience using an automated laboratory information system (LIS) which features on-line transcription and reporting, and electronic signature.

]]> Fri, 10 Apr 2026 00:00:00 EDT 1   Duties:
B shift:  Schedule is 1:00pm - 9:00pm Monday-Friday

 

Quality control is responsible for the analysis or inspection of products or processes for compliance with specifications and standards. Demonstrates detailed oriented attention in all facets of responsibilities. Performs analytical evaluation or test of products or processes. Demonstrates knowledge of testing methods, product usage, and applicable regulations and standards. Adheres to established policies and procedures. Establishes test methodology. Provides technical guidance and training to others on SOPs and quality guidelines. Responsible to visually inspect in-process/finished material. Consult with Quality Assurance personnel or immediate supervisor on clarification of specifications or acceptability of product as required. Refer to procedures manual, sampling charts, blueprints and/or specifications to determine number of samples, specifications to check and method to testing Product Assembly Process Sheets. Obtain samples and by use of inspection devices and visual inspection evaluates acceptability of components and finished products. Prepare required inspection reports. Consult immediate Supervisor and QA Supervisor/ Technician for clarification if questions regarding quality issues of defects, workmanship, etc. for direction and corrective action. Responsible for correct recording of traceability information, production information, cleaning and safety check documentation that is required by your assigned duties. Observe department’s safety regulations and to use personal protective equipment as required. Practice department’s good manufacturing and housekeeping procedures and complete cleaning verification checklists as required. Adhere to plant/Corporate policies/procedures, department safety and environmental regulations, Good Manufacturing Practices (GMPs) and ISO 13485 Standards. Report any unusual circumstances to immediate supervisor and perform other miscellaneous duties as assigned. Report any machine malfunction to designated individual for course of action and recommend equipment modifications to achieve improved operation. Monitor machine efficiencies and report to designated individual any machines not performing to standard.
Skills:
Applies acquired knowledge and skills to complete standard tasks Readily learns and applies new information and methods to work in assigned area Maintains appropriate licenses, training and certifications Works on routine assignments that require some problem resolution Works within clearly defined standard operating procedures and/or scientific methods Adheres to all quality guidelines Works under moderate degree of supervision Work typically involves regular review of output by work lead or supervisor Refers complex unusual problems to supervisor
Education:
HS Diploma, GED or equivalent experience, preferred 1-2 years experience in related field, preferred
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Job Summary
The Gene Therapy group is seeking to hire a Scientist I (temporary) to become an integral part of the gene therapy drug development effort. We seek candidates who think critically and have the desire and ability to learn new techniques. This position requires adaptability and an ability to perform at a high level in a fast-paced environment. The ideal candidate will leverage their mass spectrometry and chromatography expertise to develop assays in support of gene therapy programs. 

Qualifications

• Ph.D. with 1-3 years, M.S. with 6+ years, or B.S. with 8+ years of industry experience in analytical chemistry, chemical biology, biochemistry or a related field.
• Creativity and the ability to work within an interdisciplinary team to achieve technical and corporate milestones.
• Strong verbal and written communication, critical thinking, and problem-solving skills.

Technical Requirements and Skills:

• Extensive expertise in the development of targeted proteomic assays to support drug product characterization
• Hands-on experience using LC-MS QQQ/QTrap for MRM/SRM analysis (Shimadzu, Agilent, Waters, ExionLC AE, Sciex), including method development, routine instrument maintenance, and troubleshooting.
• Analyze quantitative proteomics data using proteomics analysis software (Skyline, SciexOS) and bioinformatics tools for protein and peptide quantification
• Research literature and external sources to identify new techniques and procedures
• Ideal candidate will have familiarity with ELNs (i.e. Benchling)
• Strong record-keeping and organizational skills.

Nice to Have:

• Working knowledge with recombinant protein downstream purification and characterization
• Familiarity with Olink-based proteomics, MSD, Western blot, metabolomics and unbiased proteomics analysis.

]]> Fri, 10 Apr 2026 00:00:00 EDT 0
Summary:
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints. Project will be focused on validating (IQ, OQ, PQ) of equipment.

This role is critical to accelerating equipment validation timelines and requires a candidate who can contribute immediately with minimal onboarding.

Job Responsibilities:
• Expert knowledge of Installation, Operational and Performance Qualification (IQ, OQ, PQ) of complex systems and equipment
• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
• Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
• Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
• Evaluate data and write reports to validate or indicate deviations from existing standards.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).

Must-Have Requirements:
• Hands-on experience with IQ, OQ, and PQ execution
• Experience in medical device validation
• Ability to clearly explain validation concepts (IQ/OQ/PQ)
• Ability to work independently with minimal ramp-up

Nice-to-Have:
• Prior experience with similar environments
• Experience as a repeat contractor in regulated environments
• Exposure to software validation within equipment systems

Soft Skills:
• Strong communication skills
• Ability to collaborate across teams
• Comfortable in fast-paced, high-priority environments
• Not siloed; team-oriented approach

Top Candidate Indicators:
• Can hit the ground running
• Requires minimal guidance
• Quickly understands project scope
• Demonstrates deep validation experience

Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 years experience required.]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Device Industrialisation Engineer

Join a dynamic team dedicated to advancing medical device innovation at the forefront of healthcare. As a Device Industrialisation Engineer, you will play a pivotal role within the Industrialisation Team at the Device Development Centre, contributing to cutting-edge projects in complex generics and biosimilar workstreams. This is an exciting opportunity to influence the scale-up, manufacturing, and transfer of life-changing medical devices and combination products, ensuring they meet stringent industry standards and regulations.

What You’ll Bring:

• Proven experience (5+ years) in medical device and/or combination product development within the pharmaceutical, medical devices, or related industry.
• Strong expertise in tech/design transfer activities moving from R&D into production.
• Proficiency in writing and reviewing manufacturing-related documentation, including DHF sections.
• Solid understanding of supplier management, capital equipment procurement, and process development tools.
• Knowledge of risk management and validation methods aligned with industry standards such as ISO13485, ISO14971, cGMP, and CFR210/211.
• Hands-on experience in device scale-up activities, including DFM, DFA, precision component moulding, and assembly.
• Ability to operate within a matrix management structure and interface effectively with external CMOs and suppliers.
• Fluency in English and a relevant degree in mechanical, chemical, process engineering, pharmaceutical sciences, or a related field.

Nice to Have:

• Expertise in secondary & tertiary packaging development and manufacturing.
• Experience with shipping & transport testing for medical products.
• Additional certifications or training related to industry standards and risk management.
• Exposure to sterile injectables, fill-finish processes, and assembly.

Preferred Education & Experience:

• Master’s degree, PhD, or university degree in a relevant scientific or engineering discipline.
• Demonstrable track record managing complex projects involving tech transfer and scale-up of MedTech products.
• Proven ability to lead collaboration with CMOs and equipment suppliers to deliver results.

Other Requirements:

• At least 50% of work in the Cambridge office post-induction; some travel may be necessary.
• Availability to start ASAP; contract duration approximately 12 months.

Ready to make an impact in medical technology innovation? Apply now and bring your expertise to a team committed to improving lives worldwide!
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Target PR Range: 39-49/hr DOE

Purpose/Primary Job Function
This position is in the Biologics Purification Development team of the Product Development Science & Technology department at Bioresearch Center. The candidate will be involved with all aspects of protein purification to support biopharmaceutical process development.

Key responsibilities:
• Develop purification processes utilizing clarification, chromatography, and membrane filtration technologies for recombinant proteins
• Design and execute innovative process development and characterization activities, including impurity and viral clearance studies
• Responsible for technology transfer to scale-up labs and manufacturing facilities, as well as troubleshooting and investigation activities
• Perform data acquisition, analysis, and documentation in electronic lab notebooks
• Possess strong oral, written, and collaborative skills to effectively communicate experimental procedures and results
• Provide technical support for pilot and/or GMP manufacturing of clinical materials as appropriate
• Execute evaluations of new technologies and innovations for purification processes
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 The primary functions of this position is the performance of analytical testing on raw ingredients, in-process and finished product and plant utilities.  This also includes testing for release of product to manufacturing for further processing, filling and finishing. Entry level position with growth ability within the quality lab and microbiology lab. Relocation unavailable.

Major Responsibilities:

•    Conducts raw ingredient analysis - Includes simple titrations, identity, sediment testing, etc.
•    Conducts in-process and finished product testing including:  vitamin analysis, protein analysis, mineral analysis, fat by Mojonnier extraction technique and CEM Hybrid Determination Trac, total solids determination, Iodide and chloride testing, vitamin C testing, mineral analysis, choline determination, lactose and fatty acid profiles by Gas Chromatography.       
•    Performs Standardization for test and check can (preparation, sterilization and evaluation of test and check can), KOH, potassium citrate, citric acid and final water calculations and physical tests such as pH, viscosity, grain color, sensory evaluation.
•    Makes batch adjustments by generating appropriate documentation for batch corrections and optimizations. Makes batch calculations by generation and distribution of work orders and associated controlled documentation.
•    Conduct special testing required under an Interim Operating Procedure or any testing required under certification or validation protocols and assist in investigations into testing problems as required under the Retest Policy.
•    Observes all safety rules and regulations.  Reports incidents, near misses chemical spills in the proper manner to crew leader and/or supervisor. 
•    Completes project work as assigned by supervision and management.  This may include troubleshooting and maintenance of analytical equipment and test methods, maintaining related documentation, coordinating efforts with vendors/plant/Division personnel, developing appropriate training classes.
•    Responsible for maintaining an adequate inventory of all supplies related to the analytical laboratory. Responsible for training new chemists on all laboratory operations which includes methods, procedures, documentation, maintenance, and safety.
•    Conducts control sample analysis to determine validity of concurrent testing per method, water testing of minerals and volatile organic contaminants, Clean in place (CIP) Residual testing, testing of compressed gases for moisture and hydrocarbons, daily flavor and aroma of oils and weekly peroxide testing of oils, and completes any associated documentation and housekeeping responsibilities.  Completes Daily, Weekly, Monthly and Quarterly standardization, maintenance, system suit abilities and testing.
•    The job description is illustrative of the types of duties typically performed by this job. It is not intended to be exhaustive listing of each and every essential function of the job. Because job content may change from time to time, the Company reserves the right to modify this job description at any time.


Education:

• High School Diploma or GED required and a college math and science course.  
• Bachelors Degree of Science (preferably Chemistry) preferred

Background:

•    Ability to follow verbal instructions, recognize signs, follow written directions, prepare simple reports, read and record gauge and display readings and use their knowledge of chemistry acquired through formal education with moderate assistance from supervisor.  Mathematics knowledge would include addition, subtraction, multiplication, division, decimals, fractions, proportions, and basic keyboard skills, computer skills and statistical comprehension is desirable.
•    Physical requirements for lifting and pushing 20-25 lbs. in addition to normal laboratory work.
•    The ability to effectively communicate with other chemists, operators, crew leaders and management with varying levels of education and experience.  Also recognizing the sometimes conflicting roles of manufacturing and quality assurance, and the ability to maintain clear priorities, and stay in compliance at all times.
•    Able to effectively train new chemists on all procedures and methods in the laboratories.  
This position requires a high level of flexibility, adaptability and personal accountability due to the type and timing of the work involved.
This position is NonExempt. Hours over 40 will be paid at Time and a Half. 

Pay ranges between 20-22/hr based on experience ]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Fri, 10 Apr 2026 00:00:00 EDT 1 Target PR Range: 20-27/hr
*Depending on experience

Description

Product Development Science and Technology (PDS&T), Analytical Development - Lake County (AD-LC) is a global analytical sciences organization responsible for all CMC analytical activities related to the development of therapeutic biologic products.  Our scope includes diverse pipeline of innovative therapeutic biologics medicines, including monoclonal antibodies, antibody drug conjugates (ADC), and other novel modalities, and spans support from clinical proof of concept through the transition of analytical methods and testing to commercial labs to support product launch. 

The Analytical Development – Lake County group within PDS&T is responsible for support of programs that are preparing for commercial development.  The team leads commercial method development, optimization, robustness, and validation.  In collaboration with cross-functional partners, the team supports commercial formulation and process development studies.  The team also leads tech transfer of final methods to commercial testing labs in Operations QC across the network.  Key deliverables include product control strategies informed by analytical data and method understanding; robust analytical methods suitable for commercial QC labs; comprehensive data packages that drive product and process understanding; clinical supplies release testing and stability studies to establish clinical product dating; substantial clinical trial application and marketing authorization submission content.

The Analytical Development – Lake County group within PDS&T is looking for a contractor to support laboratory activities and routine testing.  Additional laboratory testing to be assigned as appropriate.  Associated training will be provided.

 

Key Responsibilities and Qualifications

 

•            BS in Chemistry (or similar field) 0 - 2 years of experience.

•            Experience with routine laboratory activities (e.g., sample preparation, weighing, pipetting, pH measurement, solution preparation, etc.) preferred.

•            Ability to maintain a laboratory notebook in compliance with Good Laboratory/Manufacturing Practices preferred.

•            Independent understanding and execution of established methods and techniques including operation of the relevant software required once training is complete.

•            Ability to multitask and work within timelines required
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 This role is responsible for executing Quality function deliverables to support Contract Manufacturing Organizations (CMOs) involved in the production of drug substance in support of rapidly growing Clinical and Commercial Programs. This hybrid role is expected to support Monday – Friday during the hours of 8am to 4pm.  Expected to be on-site in Cambridge, MA location, three (3) days per week with Thurs being a required on-site day.  The remining 2 on-site days can be discretionary.  

This position will manage QA tasks such as deviations, change controls, and investigations involved in production of drug substance. In this role, the person will be responsible for internal QA review and approval of documentation required to support batch manufacturing and disposition. The QA Specialist role ensures that establishes standards and practices and maintains documented procedures and instructions to satisfy cGMPs and Good Documentation Practices for all clinical and commercial drug disposition activities. This individual will work closely with Quality Assurance, External Manufacturing, Quality Control, Process Sciences and Regulatory teams.

Summary of Key Responsibilities:
•Ensure product quality at drug substance contract manufacturing operations, while developing and maintaining relationships.
•Perform functions and make decisions consistent with cGMPs, GDPs and quality governance
•Provide QA support for the transfer of manufacturing processes and analytical methods for products to CMOs
•Independent review and approval of change controls, deviations, OOS, CAPA, and metrics. 
•Gather and provide metric information 
•Perform Batch Disposition in accordance with all applicable SOPs
•Review and approval of Master Batch Records and executed Batch Records.
•Support SOP generation and revisions
•Review of Protocols, Reports, Stability data and associated reports as needed
•Support of Process performance qualification (PPQ) activities, including review of relevant validation protocols and reports
•Support and preparation for company and Agency Inspections conducted at our CMOs, as needed.
•Maintain 100% training compliance
•Additional duties as assigned.
 
Qualifications
•A minimum of Bachelor’s degree in sciences or engineering
•A minimum of 3 years of QA operations experience in a GMP manufacturing facility
•Excellent understanding of FDA, EMA regulations and ICH guidelines
•Excellent organizational, communication, and interpersonal skills
•Experience with electronic Quality Management Systems (experience with Veeva is a plus)
•Experience with electronic enterprise resource planning systems (experience in SAP is a plus)

Pay ranges between 55-63/hr based on experience ]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Role Summary
The EU MDR Manufacturing Site Lead / Project Manager / Manufacturing Engineer is responsible for overseeing and managing all EU MDR implementation activities at a designated manufacturing site. This role is site?based and accountable for driving execution of MDR deliverables in alignment with the approved implementation schedule. The individual serves as the primary point of contact and liaison between the Spine EU MDR Program team and local Manufacturing, Quality, Engineering, and Operations leaders to ensure timely, compliant implementation.

Key Responsibilities
Responsibilities may include, but are not limited to, the following:

• Lead and manage all Spine EU MDR implementation activities within the assigned manufacturing site.
• Own site?level execution plans and schedules, ensuring alignment with the overarching Spine EU MDR implementation timeline.
• Serve as the primary point of contact between the EU MDR Program Lead and site Manufacturing leadership.
• Coordinate site execution across Manufacturing, Quality, Engineering, Supply Chain, and Operations teams.
• Ensure site readiness and timely completion of MDR implementation deliverables, including ECO/MCO/SMECO execution, documentation updates, and system readiness.
• Track progress against milestones, identify risks or constraints, and develop mitigation plans to protect committed timelines.
• Escalate execution issues, capacity constraints, or dependency risks to the EU MDR Program team as needed.
• Support audits, inspections, and internal reviews by ensuring implementation activities are properly documented and traceable.
• Drive adherence to standardized MDR implementation processes while accounting for site?specific execution constraints.
  Coordinates entry of all master data for assigned product lines
  Provides shop floor support for manufacturing methods and processes in machining, metal finishing and assembly operations for assigned product lines.  Maintains Manufacturing Process Planning documentation and ensures the accuracy of labor standards.  Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.

Differentiating Factors Autonomy

• Translates program?level EU MDR implementation strategy into executable, site?specific plans.
• Operates with significant autonomy to manage execution sequencing, resource coordination, and issue resolution at the site level.

Organizational Impact

• Directly impacts regulatory compliance, manufacturing execution, and supply continuity for Spine products.
• Decisions influence site schedules, resource utilization, and the ability to meet fixed EU MDR deadlines.
• Acts as the site owner for MDR implementation performance and readiness.

Innovation and Complexity

• Operates in a highly constrained regulatory environment with limited schedule flexibility.
• Addresses complex, interdependent execution challenges involving engineering changes, quality approvals, manufacturing readiness, and supply chain coordination.
• Adapts standardized MDR implementation approaches to local site realities without compromising compliance.

Communication and Influence

• Communicates regularly with site leadership, EU MDR Program leadership, and cross?functional stakeholders.
• Influences across functions to align priorities, resolve conflicts, and maintain execution momentum.
• Serves as the authoritative site voice for MDR implementation status, risks, and mitigation actions.

Required Knowledge and Experience

• Strong project or program management experience within a manufacturing environment.
• Experience leading site?based execution of regulated changes (regulatory, quality, engineering, or operations preferred).
• Solid understanding of manufacturing processes, change control, and cross?functional coordination.
• Ability to operate effectively within fixed regulatory deadlines and constrained schedules.
• Bachelor’s degree in Engineering discipline required.
• Minimum of 7 years of relevant experience, including 5+ years in project management or site leadership roles; or
• Advanced degree with a minimum of 5 years of relevant experience and 5+ years of project or site leadership experience.

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Company Description:
A clinical-stage biotechnology company based in South Korea focused on developing novel targeted protein degradation therapies for oncology.

Roles and Responsibilities:

• 
  Lead and manage small-molecule drug discovery projects.
  
• 
  Oversee collaborative research projects and national research programs.
  
• 
  Supervise laboratory operations and external research partners.
  

Qualification Requirements:

• 
  Ph.D. in Life Sciences, Chemistry, Pharmacy, Veterinary Medicine, or a related field.
  
• 
  7+ years in the biotech/pharma industry, with at least 3 years in small-molecule drug discovery.
  
• 
  Experience with clinical trial planning and approvals is a plus.
  
• 
  Fluency in English.
  

Preferred:

• 
  Experience with emerging drug modalities such as molecular glues or PROTACs.
  
• 
  Experience in end-to-end small-molecule drug development.
  
• 
  Ability to interact with international experts and stakeholders.
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 The Opportunity:  The Director, Regulatory Affairs – Business Excellence & Execution

The Director, Regulatory Affairs – Business Excellence & Execution supports operational coordination and execution across Global Regulatory Affairs (GRA), enabling alignment, communication, and follow-through between the Sr. Vice President of Regulatory Affairs and the broader regulatory organization.

This role partners closely with the Sr. VP and Regulatory Leadership Team (RegLT) to support department priorities, manage leadership team operations, and coordinate activities across regulatory subfunctions.

The position focuses on keeping priorities moving forward by facilitating cross-functional coordination, maintaining visibility into execution, and ensuring consistent follow-through across GRA. This includes supporting governance forums, enabling communication across functions, and providing insight into progress, risks, and key activities.

Primary Responsibilities

Regulatory Leadership & Governance

• 
  Coordinate RegLT meetings and department-wide offsites, including agenda development, content coordination, and action tracking.
  
• 
  Support follow-through on leadership decisions, ensuring clear ownership and timelines.
  
• 
  Lead the Regulatory Working Group to support alignment of cross-functional priorities, policies, and procedures.
  
• 
  Facilitate discussions, support decision-making, and track execution of agreed actions.
  

Leadership Support & Cross-Functional Coordination

• 
  Support communication and alignment between the Sr. VP of Regulatory Affairs and regulatory subfunctions.
  
• 
  Provide coordination and follow-through on leadership priorities and initiatives.
  
• 
  Coordinate cross-functional regulatory activities, including planning, tracking, and issue escalation as needed.
  
• 
  Liaise across subfunctions to ensure consistent communication and awareness of key activities.
  

Execution Tracking & Reporting

• 
  Maintain visibility into key regulatory activities, deliverables, and commitments across subfunctions.
  
• 
  Develop and maintain dashboards and reports to track progress, risks, and execution gaps.
  
• 
  Provide regular updates to support awareness and decision-making across leadership.
  

Process & Business Excellence

• 
  Support development and refinement of regulatory processes and ways of working.
  
• 
  Coordinate cross-functional input into procedural documentation to ensure consistency and alignment.
  
• 
  Contribute to continuous improvement efforts to enhance efficiency and clarity across GRA.
  

Required Skills, Experience and Education:

• 
  Minimum of 8–12 years of experience in Regulatory Affairs, with experience in business operations, project management, or functional execution within the life sciences industry.
  
• 
  Strong understanding of how Regulatory Science and supporting regulatory subfunctions interact.
  
• 
  Proven ability to manage multiple priorities with strong attention to detail and consistent follow-through.
  
• 
  Experience working in a cross-functional, matrixed environment.
  
• 
  Demonstrated ability to coordinate stakeholders and support execution of complex initiatives.
  
• 
  Strong communication and interpersonal skills, with the ability to engage effectively across all levels, including senior leadership.
  
• 
  Ability to operate independently, driving work forward with minimal direction in a fast-paced environment.
  
• 
  Strong organizational skills and judgment, with the ability to navigate ambiguity.
  

Preferred Skills:

• 
  Experience supporting leadership team operations (e.g., meetings, offsites, action tracking) .
  
• 
  Experience working closely with or supporting senior leadership.
  
• 
  Experience facilitating cross-functional forums or structured discussions.
  
• 
  Experience developing dashboards or reports to track execution and progress.
  
• 
  Familiarity with regulatory systems (e.g., RIMS) and project management tools (e.g., Smartsheet).
  
• 
  Experience contributing to process improvement or operational initiatives.
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 0
Summary:
The main function of a buyer is to purchase machinery, equipment, tools, parts, supplies or services necessary for the operation of an establishment. A typical buyer is responsible for buying goods and services for use by their company or organization. A purchasing agent is responsible for the purchase of machinery, equipment, parts, or services necessary for the operation of an establishment.

Job Responsibilities:
• Review and potentially optimize suppliers based on price, quality, selection, service, support, availability and other relevant factors.
• Approve purchases of the highest quality merchandise at the lowest possible price and in correct amounts.
• Approve purchase orders, solicit bid proposals, and review requisitions for goods and services.
• Instruct staff on how to resolve problems related to undelivered goods.
• Instruct staff on methods of negotiation, renegotiation and administration of contracts with suppliers, vendors and other representatives.
• Confer with staff, users, and vendors to discuss defective or unacceptable goods or services and determine corrective action.
• Evaluate and monitor contract performance to ensure compliance with contractual obligations and to determine need for changes.
• Manage just-in-time inventory.
• Attend trade shows.

Skills:
• Verbal and written communication skills, attention to detail, negotiation skills and interpersonal skills.
• Ability to analyze financial reports, price proposals and other technical data.
• Ability to accurately document and record customer/client information.
• Basic mentoring skills necessary to provide support and constructive performance feedback.
• Ability to evaluate suppliers.
• Knowledge of applicable laws and regulations related to purchasing.
• Knowledge of supply chain management.
• Previous experience with computer applications, such as Microsoft Word and Excel.

Education/Experience:
• Bachelor's degree in finance or a related business field required.
• 5-7 years finance related experience required.]]> Fri, 10 Apr 2026 00:00:00 EDT 1 *depending on experience

Summary:
The main function of a Quality engineer II is to support movement of production lines from one building to another. The Quality Engineer will support tasks assigned by the project engineer lead for the production line movement activities. The Quality engineer will help create, execute, and review validations and qualifications associated with the production lines being moved.

Job Responsibilities:
• Support validation and qualification activities associated with moving production manufacturing lines between buildings.
• Create, execute and review protocols and reports associated with requalification and validation activities.
• Support process confirmation activities for manufacturing line moves.
• Support calibration and confirmation activities associated with inspection and testing equipment
• Support physical movement of portable equipment between buildings as necessary.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Experience as a quality engineer working in medical device industry.
• Ability to create and execute protocols and reports related to qualification and validation activities.
• Background in validation of manufacturing lines, inspections, test methods, etc.

Education/Experience:
• Bachelor's degree in engineering required.
• 2-4 years experience as a Quality Engineer required]]> Fri, 10 Apr 2026 00:00:00 EDT 1 The Opportunity:  Clinical Trial Assistant I

This is a unique opportunity for an entry-level Clinical Operations Professional. As a Clinical Trial Assistant I (CTA I), you will be responsible for acting as an integral member of the clinical study team(s) and will be tasked to support the execution and management of clinical trials. Reporting into the Director (D) you will play a critical role in ensuring trials and studies align with all applicable standards.

Responsibilities:

• 
  Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) Guideline
  
• 
  Assist in the development, review, distribution, and archiving of study specific documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
  
• 
  Will lead the set-up and maintenance of the trial master files (TMF), if applicable, and work with the contract research organization (CRO) to audit and resolve discrepancies.
  
• 
  Assist project team(s) with sample management and generate trial progress tracking systems.
  
• 
  Tracks and prepare study-specific information utilizing databases, trackers, and other study tools.
  
• 
  Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal study team meetings.
  
• 
  Gather investigator and site information to support study start-up, maintenance, and close-out activities.
  
• 
  Assist in contacting investigator sites to provide study specific information.
  
• 
  May serve as the point of contact for study sites and study monitors for clinical supplies, document collection, and preparation for close-out visits.
  
• 
  Work with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
  
• 
  Liaise with Clinical Supply and other cross functional teams with processing shipments, returns, and assists with in-house drug, specimen, and ancillary supply reconciliation.
  
• 
  Support other clinical operations activities as appropriate.
  

Required Skills, Experience and Education:

• 
  Bachelor’s degree in biological sciences or health-related field required.
  
• 
  1-3 years relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
  
• 
  Has knowledge of GCP ICH Guidelines .
  
• 
  Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  
• 
  Excellent written/verbal communication and interpersonal skills.
  
• 
  Demonstrate proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  
• 
  Travel may be required (~10%).
  

Preferred Skills:

• 
  Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
  
• 
  Oncology experience preferred.
  
• 
  Attention to detail.
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 0 Job Summary

As part of our CMS Sales Team, you will be responsible for selling our non-invasive wearable cardiac defibrillator system, and other products such as our portfolio of cardiac diagnostic services to Health Care Professionals in the hospital and out of hospital setting. This includes the initial sales call as well as support activities to promote consistent use (Local Medical Education Programs, Tradeshows, clinical symposiums and conferences). Call points include: Physicians (Cardiologists, Electrophysiologists, Hospitalists, CT Surgeons etc.), Nurse Practitioners, Physician Assistants, nurses, case managers and administrators. Other duties include selling the value of the Patient Management System (ZPM) to clinicians as well as educating HCP's and staff about the types of patients indicated for a WCD and all essential ordering and billing requirements.

Essential Functions

 

• 
  Provide customers with relevant clinical data that supports the risk of Sudden Cardiac Death in certain patient types and the role of the WCD in protecting these patients
  
• 
  Provide customers with relevant clinical, reporting, and technical information that supports the utilization of Cardiac Diagnostic products for appropriate patients.
  
• 
  Responsible for sales and supporting activities to drive consistent utilization
  
• 
  Responsible for achieving assigned sales objectives
  
• 
  Responsible for selling the value of the Patient Management (ZPM) to clinicians as well as educating HCP’s and staff about all essential ordering and billing requirements for the WCD
  
• 
  Maintain database of accounts, prepare and submit reports
  
• 
  Maintain a yearly and quarterly business plan
  
• 
  Manage field expenses and submit reports in a timely manner
  
• 
  Attend key Medical Education Programs, exhibits and conventions
  
• 
  Become a company expert and resource on both products and relevant industry trends
  
• 
  Master both Customer Centric Selling and Integrity Selling skills
  
• 
  Maintain a collaborative and professional working relationship with all business partners
  
• 
  Represent  in a professional and ethical manner. Always maintain a positive attitude
  
• 
  Communicate openly and share information with others
  
• 
  Analyze and report on trends that you observe within your territory
  
• 
  Ensure all relevant information and documentation is provided to intake and reimbursement to ensure appropriate and timely filing of billing claims
  
• 
  Maintain credentialing/access to all assigned accounts at all times
  

Required/Preferred Education and Experience

• 
  Bachelor's Degree From four-year college or university required
  
• 
  3-5 years sales experience in medical equipment sales or specialized/hospital based pharmaceutical sales or 5 years of successful sales experience, with at least one of those years in healthcare sales required
  
• 
  Cardiology experience preferred
  
• 
  Valid state driver’s license Required
  

Knowledge, Skills and Abilities

• 
  Ability to be credentialed/have access privileges in all assigned customer accounts.
  
• 
  Documented history of sales success
  
• 
  Proficient with Microsoft Office Suite
  
• 
  Must live within the assigned territory
  
• 
  Internal candidates that do not meet the sales experience criteria above may be hired if they have demonstrated a sustained ability to meet the expectations of a sales role and have been in a sales support role for a minimum of 1 year OR have successfully performed within a Associate Territory Manager role.
  

Physical Demands

• 
  This position requires the employee to sit, stand, walk, talk, listen, hear and speak on a regular basis. May occasionally be required to stoop and bend.
  
• 
  Must be able to drive an automobile and may be required to travel by train or airplane as needed.
  

Working Conditions

• 
  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
• 
  This job is a field-based position. Employee will be responsible for working daily in hospitals, doctors’ offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs.
  

]]> Fri, 10 Apr 2026 00:00:00 EDT 0
Summary:
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings, and read and interpret blueprints.

Job Responsibilities:
Non-Conformance Reporting (NCRs)

Document, track, and manage NCRs for products, processes, or materials that fail to meet specifications.

Ensure NCRs are written clearly, accurately, and in compliance with company and regulatory standards.

Maintain NCR logs and databases for traceability and audits.

Supporting Duties
Collaborate with production, engineering, and supply chain teams to gather details for NCRs.

Ensure NCRs include root cause information, corrective/preventive actions, and disposition status.

Follow up with stakeholders to close NCRs in a timely manner.

Prepare NCR summaries for management reviews and audits.

Skills & Qualifications
Strong attention to detail and technical writing skills.

Familiarity with quality management systems (ISO 13485, FDA QSR, or industry-specific).

Ability to work with cross-functional teams to collect accurate information.

Experience with NCR software tools or ERP/QMS systems.

Education/Experience:
• Bachelor's degree in engineering required.
• 2-4 years experience required.]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Join Our Team as a Quality Technician - III 

Are you passionate about ensuring the highest quality standards and eager to contribute to a dynamic, innovative environment?. This pivotal role offers the opportunity to work in a collaborative setting, supporting continuous improvement and excellence in manufacturing processes. If you thrive in a fast-paced environment and possess a keen eye for detail, this is your chance to make a significant impact!

What You’ll Do:

As a Quality Technician, you will be responsible for performing detailed inspections, audits, and testing to uphold strict quality standards. Your role will involve analyzing data, documenting findings, and collaborating with cross-functional teams to resolve quality issues swiftly and efficiently. Your contribution ensures that our products meet regulatory requirements and customer expectations, making you an essential part of our quality assurance team.

Required Skills:

• Proven experience in quality inspection or a similar role within manufacturing or industrial settings.
• Strong attention to detail with excellent analytical and problem-solving skills.
• Proficiency in using measurement tools and quality testing equipment.
• Good understanding of quality standards and regulatory requirements.
• Effective communication skills, both written and verbal.
• Ability to work independently and as part of a team.

Nice to Have Skills:

• Knowledge of Lean, Six Sigma, or other quality improvement methodologies.
• Experience with data analysis software or quality management systems.
• Previous experience working in a regulated industry such as pharmaceuticals or medical devices.
• Certification in quality or inspection (e.g., CQI, IRCA).

Preferred Education and Experience:

• A minimum of a high school diploma; technical qualification or degree in Quality, Engineering, or related fields is advantageous.
• Prior experience in a similar quality inspection role is preferred, ideally with at least 2 years of relevant experience.

 

Take the next step in your quality assurance career and apply today to be part of a forward-thinking organization committed to excellence. We look forward to reviewing your application!
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 A global B2B solutions provider serving pharmaceutical manufacturers is appointing a senior commercial leader to take full ownership of the Germany and Switzerland region. This role carries strategic and people leadership responsibility, with direct accountability for growth, team performance and customer impact.

Reporting into the European Commercial VP, you will lead an established regional organisation, combining direct line management with broader matrix influence. This is a hands on leadership role for someone who has built and scaled high performing sales teams in complex, consultative environments.

Scope of the role

You will own the commercial strategy and execution across Germany and Switzerland, ensuring consistent performance, strong customer relationships and sustained growth.

Key responsibilities include

• Full commercial ownership for the DACH region across revenue growth and profitability
• Direct leadership of senior sales managers with broader responsibility for an extended sales organisation
• Coaching and developing regional sales leaders and field teams to consistently raise performance
• Driving disciplined execution across forecasting, pipeline management and account strategy
• Partnering closely with European leadership on regional strategy and investment decisions
• Acting as senior commercial interface to key pharmaceutical manufacturing customers
• Translating regional objectives into clear priorities and execution plans for the field

Your background

This role requires proven senior level commercial leadership within B2B environments serving pharmaceutical manufacturers.

Essential experience includes

• Experience leading teams of regional sales managers and sales representatives
• Minimum five years selling B2B solutions to pharmaceutical manufacturers
• Track record in consultative selling of complex products or services such as chemicals or technical solutions
• Demonstrated success growing revenue and improving team performance with clear, measurable results
• Strong strategic mindset combined with operational discipline

Skills and profile

• Commercially sharp with the ability to challenge and elevate team performance
• Credible at executive customer level
• Structured, data driven and confident managing through others
• Comfortable operating in an international, matrix led organisation

Languages

• Native level German
• Strong working English

]]> Fri, 10 Apr 2026 00:00:00 EDT 1
Job Details:

Mass spectrometry scientist and analytical protein chemist with a consistent track record in biopharmaceutical protein support, scientific eminence and leadership and mentoring skills.

In this vital role you will be part of the BEAM group providing scientific and technical expertise to support early discovery research through to later stage molecule optimization and late-stage selection pipeline of drug candidates. This position is an exciting opportunity to unlock the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics.

Experience using analytical characterization techniques such as RPLC-MS for intact protein, reduced and subunit protein mass analysis. Experience using high-throughput MS like Rapidfire-MS is a plus.

Experience with protein digestion and RPLC-MS/MS to map and characterize post translational modifications such as deamidation, isomerization and oxidation and associated data processing would be a plus.

Experience generating, processing and using large LC-MS analytical data sets

Experience with both ESI and MALDI techniques would be useful

Communicate (verbal and in written) scientific concepts and results

Work independently in advancing projects and studies within required deadlines

Follow protocols and procedures, maintain accurate records in an electronic lab notebook

Basic Qualifications:

Masters degree and 2 years of biopharmaceutical Analytical Chemistry, Biochemistry or equivalent

Or

Bachelors degree and 4 years of biopharmaceutical Analytical Chemistry, Biochemistry or equivalent

Preferred Qualifications

Masters degree and 2 years of biopharmaceutical Analytical Chemistry, Biochemistry or equivalent

Knowledge of multiple mass spectrometric (MassHunter, XCalibur, MassLynx) chromatographic (ChemStation, Chromeleon) control software is preferred. Knowledge of Protein Metrics data processing software is a plus.

Knowledge of statistical processing of data, including related software such as, but not limited to Excel, Spotfire or JMP is preferred]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Join Our Team as an Omnichannel Strategist – Drive Seamless Customer Experiences

Are you passionate about creating integrated, innovative marketing strategies that connect across all channels? We’re seeking a dynamic Omnichannel Strategist to lead the development and execution of comprehensive omnichannel plans that elevate brand engagement and deliver exceptional customer journeys. If you thrive in a fast-paced environment and have a knack for aligning digital, physical, and social touchpoints, this is your chance to make a meaningful impact in a forward-thinking organization.

What You’ll Need to Succeed:

• Proven experience in developing and implementing omnichannel marketing strategies
• Strong understanding of digital marketing, social media, and brick-and-mortar retail integration
• Excellent analytical skills to interpret data and optimize campaigns
• Creative thinking coupled with strategic planning ability
• Excellent communication and collaboration skills
• Knowledge of marketing technology platforms and analytics tools

Nice to Have Skills:

• Experience with CRM systems and marketing automation tools
• Familiarity with customer journey mapping
• Ability to manage cross-functional teams and vendors
• Knowledge of emerging marketing channels and trends

Preferred Education and Experience:

• Bachelor’s degree in Marketing, Business, Communications, or related field
• Minimum of 3-5 years of experience in omnichannel marketing or a related role

Other Requirements:

• Willingness to stay updated on evolving marketing technologies and industry best practices
• Strong project management skills and attention to detail

If you’re ready to shape and execute innovative omnichannel strategies that drive success, we want to hear from you. Take the next step in your career and apply now — your future as an Omnichannel Strategist awaits!
]]> Fri, 10 Apr 2026 00:00:00 EDT 1

An established cardiovascular device business is strengthening its clinical field team and is recruiting a Clinical Specialist to support TAVI and coronary therapies across the Czech Republic. This role is centred on procedural excellence, clinical education and long term therapy adoption within leading cardiac centres.

You will spend the majority of your time in the cath lab, working side by side with interventional cardiologists and clinical teams during live procedures. Acting as the clinical and technical expert, you will support safe device use, troubleshoot in real time and help teams build confidence with complex interventions.

Beyond case support, you will play a key role in training physicians, nurses and hospital staff on best practice and therapy integration. You will support new site start ups, help existing centres expand their programmes and act as the clinical bridge between hospitals and the wider organisation.

This position suits someone who is comfortable in high pressure clinical environments and motivated by patient outcomes rather than sales targets. Collaboration with sales colleagues is essential, but responsibility for revenue does not sit within this role.

What you bring

You have hands on experience in interventional cardiology, structural heart or a closely related cardiovascular field. Exposure to TAVI, coronary interventions or implantable devices is essential. You understand cath lab workflows, communicate confidently with senior clinicians and are able to work independently across a national territory. A life sciences or clinical degree is required.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 18 month contract I full -time

A global organisation in a regulated laboratory environment is investing in a multi year lab digitalisation programme. The lab estate is currently highly paper based with a clear roadmap to become fully digital and AI ready within the next two to three years.

Following the completion of a detailed analysis phase delivered by an external partner, this programme is now moving into delivery. An experienced Infrastructure Engineer with strong laboratory systems exposure is required to take ownership of execution and to manage multiple specialist partners.

This is a long term onsite friendly engagement with home working flexibility when operationally possible and a strong likelihood of permanent conversion at the end of the initial term.

---

The role

• You will act as the technical lead for lab infrastructure and connectivity across a complex regulated environment.
• You will build and maintain core lab networks, domains and data flows while ensuring reliable integration of laboratory instruments and digital systems.
• You will personally install and configure middleware and device integration layers while also coordinating third parties including equipment vendors, system integrators and software providers.
• You will oversee delivery of recommendations coming out of the analysis phase and translate them into stable compliant production systems.
• You will work closely with lab users, quality teams and IT stakeholders to modernise the lab landscape without disrupting ongoing operations.

---

Required experience

• Infrastructure Engineer with broad end to end systems experience across networks, domains and lab environments
• Strong understanding of lab data flows, instrument connectivity and device integration
• Hands on experience building and maintaining middleware and lab integration layers such as SDSm environments
• Proven ability to manage third party delivery including integration partners, equipment providers, ELN and LIMS vendors and internal network teams
• Deep experience working in regulated laboratory environments with strong knowledge of GxP, CSV and data integrity requirements
• Experience maintaining lab systems including virtualised environments, VMware, electronic lab notebooks and LIMS platforms
• Comfortable working onsite when required with flexibility to work from home when appropriate
• German language skills highly desirable

]]> Fri, 10 Apr 2026 00:00:00 EDT 1

A medical device organisation is expanding its structural heart sales team and is hiring two TAVI Sales Representatives to support growth across the Czech Republic. These roles focus on driving adoption within key cardiac centres and building long term clinical partnerships in a complex, high value therapy area.

The role

You will be responsible for sales performance within a defined territory, working closely with interventional cardiology teams to increase procedure volumes and embed the TAVI solution into routine clinical practice.

Key responsibilities include

1. Driving sales growth of a TAVI portfolio across assigned Czech regions
2. Building strong relationships with interventional cardiologists, cardiac surgeons, cath lab staff and hospital stakeholders
3. Supporting case coverage and on site clinical activity to enable safe and effective use of the technology
4. Developing new accounts while expanding utilisation in existing centres
5. Managing hospital procurement processes and tender activity
6. Maintaining accurate forecasts and sharing market insights with regional leadership

Your background

This role suits commercial professionals with experience in complex hospital sales who are ready to grow within structural heart.

Essential experience includes

1. Medical device sales experience within cardiology or interventional therapies
2. Exposure to TAVI, structural heart, cath lab or implantable technologies
3. Strong knowledge of hospital decision making and purchasing frameworks in the Czech Republic
4. Ability to engage credibly with senior clinicians and influence clinical practice
5. A proactive, resilient mindset with clear ownership of territory results

Why this opportunity

These positions offer the chance to join a growing TAVI business with strong clinical relevance and long term market potential. You will gain visibility, autonomy and the opportunity to build deep expertise within a flagship cardiovascular therapy.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1

A cardiovascular medical device organisation is building its local marketing capability and is recruiting a Marketing Specialist to support the TAVI business in Spain. This role sits at the intersection of strategy, execution and field collaboration, with a strong emphasis on market activation and therapy growth.

You will be responsible for translating regional strategy into effective local marketing activity that supports adoption across Spanish cardiac centres. Working closely with sales and clinical teams, you will develop campaigns, tools and messaging that resonate with both clinical and hospital stakeholders.

The role has broad exposure, covering product positioning, launch support, customer events and ongoing programme optimisation. You will own adaptation of global materials for the Spanish market, ensure consistency of messaging and provide feedback based on field insight and market dynamics.

This is a hands on role suited to someone who enjoys execution as much as planning and who is comfortable operating in a fast moving, highly specialised therapy area.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Position: Area Sales Manager (TAVI)
Location: Portugal/ Remote 

We are currently partnered with a client who are global world class leaders in designing, manufacturing and distributing clinically relevant, state-of-the-art medical devices to alleviate human suffering and improve their quality of life.
They are always growing and with their current plans, they are looking for multiple clinical application specialists to join them and bring experience in working within Cardio/TAVI.
The ideal candidate will identify and secure sales opportunities to drive company revenue. Responsibilities also involve formulating, executing, and assessing sales strategies. This role requires robust leadership and mentoring abilities to foster the sales team's growth. Previous Sales experience in TAVI.

Responsibilities:
• Support sales team development
• Collaborate with representatives to cultivate and meet potential leads
• Monitor and document all sales activities
• Develop and implement sales strategies based on market analysis
• Achieve business growth targets while adhering to organizational guidelines
• Manage a team of senior executives, aiding in their development with open and constructive dialogues
• Review and strategize monthly action plans to meet sales budgets
• Create and execute plans for promotional activities, CRM strategies, and ensure effective implementation of marketing strategies to meet sales objectives
• Assess territory potential, considering market trends and competitor activities
• Profile and enlist new doctors as per business needs
• Coordinate with government sales teams for product availability and demand generation at various institutions
• Cultivate enduring relationships with Key Opinion Leaders/Business leaders through regular scientific engagements and adequate coverage frequency in the assigned territory
• Follow up with customers to address concerns and ensure satisfaction, collaborating with other departments for timely resolutions

Qualifications:
• Bachelor’s degree in Life Sciences or Biotechnology preferred
• 3+ years of medical devices sales experience
• Experience selling TAVI products
• Experience with TAVI products needs to be within the last 2-3 years
• Strong decision-making and financial management skills
• Proficient in regional language both in written and verbal communication, intermediate level in English
• Flexibility for occasional travel and overnight stays as per business requirements
 ]]> Fri, 10 Apr 2026 00:00:00 EDT 1
Duties:    
JOB SUMMARY:
We are seeking a Compliance Specialist to contribute to our growing Analytical Development team. The Compliance Specialist will participate in all aspects of compliance and development management in Analytical Development, working closely with cross-functional teams to onboard instruments/equipment, performing data/document/record review, and authoring various compliance documents.
This position may also require hands-on laboratory experience from time-to-time working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for company projects.
This is an on-site, technical laboratory-based position that involves development, validation, and execution of analytical methods for testing of biologics. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, R&D, Formulation Development, QC, and other technical groups by providing analytical testing support and compliance management.

Job Responsibilities:

• Work closely with the CMC team to manage and coordinate analytical activities
• Manage early and/or late phase drug substance and drug product analytical activities at contract testing laboratories (method development, method qualifications/validations, method transfers, analytical investigations support)
• Execute technical analytical methodologies to support development and validation of test methods.
• Author and review raw data (e.g. stability data packages and ad hoc testing), analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control.
• Assist in authoring and reviewing various regulatory submission and interaction documents
• Assist in the developing, authoring, and/or reviewing standard operating procedures
• Manage reference materials and reference standards inventory and (re)qualification testing
• Manage vendor maintenance and calibration for AD-owned equipment, instruments, and systems
• Ensure adherence to GMPs, GLPs, GCPs and GDPs where required.

Skills:    

• Experience in drafting protocols, methods, reports, and/or procedures.
• Experience in performing change control, deviation, laboratory investigation, and/or other quality records.
• Be able to communicate technically and strategically across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics; R, Python, or other statistical tools preferred.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.

Preferred Qualifications:

• Demonstrated experience in managing outsourced analytical activities
• Demonstrated experience in QC data review of release and stability data packages
• Experience in Liquid Chromatography and/or Immunoassays is highly desired.

Education:    

• Bachelor’s degree in biological sciences or related field with 4+ years of progressive experience in the biotechnology or pharmaceutical industry.
• 3+ years of experience in a regulated/GMP environment.
• 2+ years of experience in a quality function (QC or QA organization)

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Target PR Range: 43-53/hr DOE
JOB DESCRIPTION
SUMMARY/JOB PURPOSE: Seeking a Staff Accountant/Senior Accountant for a six-month assignment.

The position will support R&D Accrual team with day to day accounting tasks during system Implementation

Job Description:

• Interpret R&D contracts and determine appropriate accrual schedules and/or models
• Update clinical site accrual models based on current patient enrollment data and latest site budgets
• Analyze, review, and examine R&D related invoices and related support to populate R&D accrual accordingly
• Ensure monthly R&D accrual schedule is complete and ready for manager review
• Work closely with accounting on month end and quarter end close processes, including but not limit to accruals, reporting and reconciliations, etc.
• Prepare complex journal entries on monthly/quarterly basis
• Collaborate with internal and external stakeholders and vendors to ensure accuracy and accrual completeness
• Support both external quarterly and annual audits
• Ensure compliance with Company policies and the application of Generally Accepted Accounting Principles (US GAAP)
• Assist in process improvements and system implementations as needed
• Support ad hoc projects as needed

]]> Fri, 10 Apr 2026 00:00:00 EDT 1

A cardiovascular medical device organisation is strengthening its clinical field presence and is recruiting a Clinical Specialist to support TAVI and coronary therapies across Portugal. This role is focused on procedural support, clinical education and long term therapy adoption within key cardiac centres.

You will work directly in the cath lab environment, supporting physicians and clinical teams during live cases and acting as the clinical and technical expert for complex cardiovascular procedures. The role is non?commercial, but closely aligned with sales colleagues to ensure safe adoption and sustained use of the therapy.

The role

You will play a central role in building clinical confidence and ensuring procedural excellence.

Key responsibilities include

• Providing on site clinical and technical support during TAVI and coronary procedures
• Supporting physicians, nurses and cath lab teams with device use and procedural best practice
• Acting as the primary clinical expert during cases, including troubleshooting and real time guidance
• Supporting new site start ups and expansion of existing programmes
• Delivering structured training and education to hospital teams
• Working closely with sales partners to support therapy adoption and utilisation
• Feeding back clinical insights and unmet needs to internal teams

Your background

This role suits a hands on clinical professional who is confident working in high pressure procedural environments.

Key requirements include

• Experience as a clinical specialist or similar role within interventional cardiology or structural heart
• Direct exposure to TAVI, coronary interventions or implantable cardiovascular devices
• Strong understanding of cath lab workflows and hospital clinical practices
• Ability to work independently across a national territory
• Clear, confident communication with senior physicians and multidisciplinary teams

Education and languages

• Degree in nursing, biomedical science or a related life science discipline
• Fluency in Portuguese with good working English

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Global Submission Lead

Are you a strategic thinker with a passion for orchestrating complex global submissions? We are seeking an experienced and dynamic Global Submission Lead to drive critical regulatory submissions across international markets. This pivotal role offers the opportunity to lead cross-functional teams, ensure compliance, and streamline global submission processes, making a significant impact in a fast-paced and innovative environment.

Overview
As the Global Submission Lead, you will be at the forefront of coordinating and executing global regulatory submissions to ensure timely and compliant product approvals. Your leadership and meticulous attention to detail will be essential in navigating complex regulatory landscapes, collaborating with international teams, and driving submission excellence. This is your chance to contribute to groundbreaking initiatives and shape the future of global healthcare products.

Required Skills

• Proven experience in global pharmaceutical or biotech submission processes
• Strong knowledge of regulatory requirements and guidelines across multiple regions
• Excellent project management and organizational skills
• Ability to lead cross-functional teams and coordinate multiple stakeholders
• Superior communication and writing skills to prepare clear, comprehensive documentation
• Proficiency with regulatory submission systems

Nice to Have Skills

• Experience with electronic Common Technical Document (eCTD) submissions
• Familiarity with regulatory authorities’ specific submission portals and procedures
• Prior experience working in a highly regulated environment within the healthcare industry
• Multilingual abilities are a plus

Preferred Education and Experience

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degrees are advantageous
• Minimum of 5 years’ experience in regulatory affairs or submission management for pharmaceutical/biotech products
• Demonstrated success in managing global submission projects from inception to approval

Take the next step in your career by leading global regulatory submissions and making a meaningful impact in the healthcare industry. Apply now to join a dedicated team committed to excellence and innovation!
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 --

Responsibilities:
• Supports global laboratories with ongoing projects related to Laboratory Information Management Systems (LIMS), in particular Thermo SampleManager.
• Works with Global Quality Systems support team on creating and routing document change controls including administrative updates to procedures and training.
• Works with global and site resources to manage requests related to inventory management.
• Assists with global digital readiness preparation and other project activities on an as needed basis.
• Willingness to learn and provide support

Desired experience:
• Lab administration, supporting quality systems used by the laboratory, especially LIMS such as SampleManager.
• Laboratory analyst with chromatography experience is a plus but not required.
• Scientific background with experience following analytical test methods.
• Multi-site or multi-stakeholder project work supporting laboratory quality systems.

*CO/NYC candidates might not be considered
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Can you please confirm your top 3 skills sets required?  Production support, communication, production transfer, critical thinking  

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Production Support, Product transfer, Process validation

What products (if any) will this role support?  Cryo-Ablation Probes

What is your target years of experience?  1-5 years of experience

 
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Position Summary:
 
As a Pathology assistant you will work closely with supervising pathologists to perform tissue transfer and large specimen grossing with appropriate tissue sampling and gross description composition.  
 
Responsibilities:
 
•    Gross pathology prosection and description with submission of appropriate tissue for thorough pathology evaluation
•    Assist with preparation of frozen section slides
•    Prosect and assist in report generation of rare fetal and adult autopsies
•    Assist in appropriate quality control and quality assurance measures
•    Assist pathologists in preparing for tumor board or other presentations
 
Experience & Required Qualifications:
 
•    Master’s Degree in Pathologist Assistant (PA) from an accredited college or university, graduation from a NAACLS-accredited Pathologists’ Assistant program preferred, Bachelor’s Degree from an accredited college or university in one of the chemical, physical, or biological sciences 
•    Pathologist assistant certification under ASCP
•    Five years of laboratory experience as pathology assistant  
•    (Exceptions to these requirements are in respect to individuals qualifying prior to April 1, 1972 (see NYCRR section 58-1.5(5).) ]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Target PR Range: 38-48/hr
*Depending on experience

The ideal candidate is expected to demonstrate working knowledge and understanding of formulation and manufacturing process development for sterile liquid drug products, including solutions, emulsions, and suspensions. Knowledge of polymer sciences is highly desired. Experience with various sterilization techniques for liquid drug products, such as filtration, and autoclaving, is desired. The candidate should have experience with analytical measurements and characterization techniques such as pH, osmolality, viscosity/rheology, turbidity, particle size, and physical appearance. Hands-on experience with HPLC and UPLC (with detectors such as UV, PDA, and RI) is also desired but not required.

Key Responsibilities:

Th essential responsibilities of this position include:
o Conducting laboratory experiments for development of pharmaceutical products, with focus on sterile liquid dosage forms under supervision and guidance of the group members.
o Conducting analytical & characterization experiments to generate scientifically sound data supporting the formulation and manufacturing process development efforts of liquid dosage forms.
o Designing and interpreting experiments independently whenever the situation demands.
o Employing problem-solving and creative scientific skills.
o Working independently to generate accurate, reliable data on time and accurately documenting in electronic laboratory notebooks.
o Practicing good communication (oral and written) and interpersonal skills.

Upon assignment given by the team, the candidate will independently plan and execute lab-scale experiments related to sterile liquid formulation and manufacturing process development. Prompt and accurate documentation of experiments, results, and conclusions to ensure data integrity and accuracy is critical. The candidate independently analyzes and interprets technical data and utilizes statistical techniques as needed.

Additional responsibilities include proper maintenance of laboratory equipment and instrumentation to ensure laboratory operational capability.

MINIMUM REQUIREMENTS FOR EDUCATION AND EXPERIENCE:

This position requires a bachelor’s degree in chemistry, chemical engineering, pharmacy, or other relevant scientific discipline with 3-5 years of relevant industry experience or a master’s degree in chemistry, chemical engineering, pharmacy or other relevant scientific discipline with 2 years of relevant industry experience.

Strong technical writing and communication skills. Must be proficient using Word, Excel, and statistical software. Knowledge of fundamental application of statistics is preferred.

Experience in analyzing data and writing technical reports is desired.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Onsite role, Irvine, CA, medical device experience preferred

Role Purpose

Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

Essential Job Functions

Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout

Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).

Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan

Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel

Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance.

Assist with any site remediation activities, as applicable

Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training

Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas

Required

Bachelor's Degree or Equivalent Life Sciences or Nursing

3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry

Experience with electronic data capture.

Preferred

Licenses and Certifications: Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)

Pay $45-57/hr based on experience
]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Seeking a contract Process Engineer/Research Associate to provide hands-on laboratory and manufacturing support of AAV (rAAV) vector research and late-stage clinical gene therapy programs.

This role is execution-focused, supporting upstream and downstream manufacturing operations, routine experiments, and process development studies working in close coordination with manufacturing and MSAT staff. The contractor will contribute to the timely completion of manufacturing and laboratory studies, data collection, and manufacturing readiness ensuring alignment with existing protocols to support early-stage gene therapy programs, technology development, and internal research priorities.

This is a laboratory-based contract role intended to support day-to-day manufacturing and experimental execution working closely with pre-clinical manufacturing and MSAT scientists. This role does not carry people-management or long-term program ownership responsibilities and is well suited for individuals who thrive in an execution-driven environment.

Key Responsibilities

• · Execute routine and defined rAAV manufacturing and laboratory activities for research and GLP-grade studies following established protocols and batch records.
• · Perform hands-on upstream and downstream operations, including:
  • o Cell culture and maintenance
  • o Vector production in shake flasks, WAVE bioreactors, and/or stirred-tank bioreactors
  • o Centrifugation, filtration, chromatography, and related purification steps
• · Support process development and experimental studies, including process characterization and robustness testing, at small and pilot-scale by executing assigned experiments and manufacturing runs according to approved protocols, batch records, and study plans, ensuring accurate data generation and traceability.
• · Maintain clear, real time and accurate documentation of laboratory activities, experimental results, and manufacturing data in paper or electronic systems in accordance with department procedures to ensure compliance and data integrity.
• · Assist with batch record completion, data compilation, and data review.
• · Communicate experimental progress, observations, and results to project stakeholders in a clear and timely manner.
• · Support manufacturing investigations and troubleshooting activities, including execution of confirmatory experiments and data collection to inform root-cause analysis.
• · Contribute to technical protocols, experimental reports, and summary presentations describing executed work and generated data, as needed.
• · Support daily laboratory operations, including:
  • o Equipment setup, operation, and routine maintenance
  • o Coordination and execution of laboratory activities
  • o Maintaining a clean, organized, and inspection-ready lab environment
  • o Ensuring materials, consumables, and reagents are available for assigned experiments in coordination with lab management and solution prep teams.
• · Follow established safety procedures, SOPs, and documentation practices at all times.
• · Adhere to all safety, quality, and data integrity requirements during laboratory and manufacturing-support activities.

Required Qualifications

• · BS or MS degree in a biological or engineering discipline required (Biotechnology, Chemistry/Biochemistry, Chemical/Biochemical Engineering, or equivalent)
• · Minimum 2 years (BS)/0 years (MS) of relevant experience in laboratory research, biologics manufacturing and a desire to continue in a laboratory-focused role, preferably within:
  • o Manufacturing
  • o MSAT
  • o Process Development
• · Experience or familiarity with upstream and/or downstream bioprocess operations
• · Comfort executing experiments under direction, following protocols, and meeting scheduled deliverables
• · Ability to work on-site in a fast-paced laboratory environment
• Preferred Experience
• · Prior exposure to cGMP manufacturing environments or manufacturing-support laboratories
• · Hands-on experience executing scale-up, scale-down, or process characterization experiments
• · Familiarity with DOE concepts and experimental execution (design and analysis support may be provided by others)
• · Experience using JMP or similar statistical tools (execution-focused)
• · Strong working knowledge of Microsoft Word, Excel, and PowerPoint
• · Excellent attention to detail and data accuracy

Ideal Contractor Profile

• · Execution-oriented with a strong preference for hands-on laboratory work
• · Comfortable working under established protocols and technical direction
• · Organized, reliable, and able to manage assigned experiments independently once trained
• · Adaptable to changing project priorities and manufacturing timelines
• · Collaborative team player who communicates clearly with scientists, engineers, and manufacturing stakeholders
• · Willing to support on-site manufacturing or lab schedule needs, including periodic weekend coverage.

]]> Fri, 10 Apr 2026 00:00:00 EDT 1 Job Summary

As a valued member of our North American Sales management team, this individual will be responsible for the direct management of CMS Territory Managers (sales representatives) and Sales Associates within an assigned region.

Essential Functions

• Manages medical equipment sales activities and is responsible for planning, organizing, and implementing sales programs for the assigned region.
• Engages with key accounts and builds relationships throughout the region.
• Responsible for consistently meeting or exceeding region performance objectives, including order counts, booked revenue quotas and profit.
• Maintain a positive attitude, control discounts and expenses to contribute positively to our profitability.
• Hires, educates, retains and promotes talented sales professionals.
• Foster a team environment within your region. Lead by example, motivate and inspire your team.
• Communicate, implement, and monitor the CMS Strategic Plan.
• Develop Territory Managers through coaching and positive reinforcement.
• Spend an average of four days per week working in the field with your TM''s.
• Manage and assess Territory Managers adherence with regional expectations to improve performance. Become a company expert and resource on both internal and competitive landscape.
• Responsible for field reinforcement of products and positioning strategy.
• Represent company in a professional and ethical manner.
• Communicate openly and share information with others.
• Analyze and report on trends that you observe within your region.
• Directly supervises Territory Managers in the field. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Required/Preferred Education and Experience

• Bachelor's Degree required
• At least three (3) years of field sales experience – client focus within cardiology, medical device and/or pharma industries required
• Five or more years of experience in medical equipment sales management – preferably cardiology. Demonstrated business acumen within the medical industry.

Knowledge, Skills and Abilities

• Proven sales leadership.
• A valid driver’s license

Travel Requirements

• 60% This job is a field-based position and requires that you reside within the assigned Region. Employee will be responsible for working daily in hospitals, doctors’ offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs. This position will require at least 60% travel. Travel may be outside the local area and overnight and could be for an extended period.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Occasionally
• Lifting - Occasionally
• Talking - Occasionally
• Hearing - Occasionally

]]> Fri, 10 Apr 2026 00:00:00 EDT 0 Target PR Range: 39-49/hr DOE

3-5 years of experience. Prefer someone who has worked or has 3-5 years of industry experience.

This opportunity is in the Cell Line Engineering group within Biotherapeutics Discovery which plays a key role in enabling reagent generation supporting diverse applications throughout therapeutic development process. Under supervision of a senior scientist in the group, the individual will primarily support mammalian cell culture work, cell line engineering, including KO, KI and OE cell lines development, cellular assays, as well as assist with lab and inventory management and sample digitization initiatives. Opportunities to expand proficiencies in cell and molecular biology applications, such as cell and genome engineering, vector design, technology development, cell-based assays development, receptor density quantification, flow cytometry, cell sorting and cloning, and other cell line development technologies also exist.

Key responsibilities include:
• Mammalian cell culture (immortalized, cancer and primary lines)
• Generation and maintenance of cell-lines for antibody discovery and assay development.
• Cellular assays
• FACS analysis and sorting
• Technology development for cell line engineering
• Consolidation of historical and recent cell line assets into digital inventory solution.
• Expansion and banking of core cell lines to ensure adequate inventories.
• Coordination of cell line inventory stocks across multiple sites, providing a foundation for Cell Bank establishment.
]]> Fri, 10 Apr 2026 00:00:00 EDT 1
Scientist, III – Biocompatibility, Tissue Material Sciences (Contractor)

JOB SUMMARY:
The Senior Scientist I - Biocompatibility is a SME related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of R&D. This individual must possess an extensive knowledge of ISO-10993 Standards and prior experience working in biocompatibility. The position will be responsible for cross-functional and cross-site collaborations and recommendations of biocompatibility activities, including establishing requirements, planning, execution and approval of biocompatibility requirements in support of regulatory submissions, project teams, operations, with a large focus on manufacturing and change control (product support).

KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE:

• Function as Subject Matter Expert for ISO-10993 (biocompatibility) assessment management with minimal supervision. This will include the design, execution and interpretation of biocompatibility evaluation strategies and programs according to relevant regulatory requirements, including biological risk assessments, technical reports, technical memoranda and other documents for internal and external distribution, including regulatory submissions.
• Responsible for creating detailed Project Plans including scientific strategy and realistic deliverables with timelines. Actively involved in the planning, execution and management of experimental studies for the safety characterization of novel and existing products.
• May serve as a sub-team or core-team member, providing support as needed for all project Teams.
• Support for on-market products, including global change-control activities as they relate to biocompatibility. Requires interacting with Manufacturing Sites.
• Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical device and other products. This includes performing gap analysis relevant to changes in biocompatibility standards or guidance.
• Prepare and deliver technical presentations to internal and external stakeholders with minimal supervision. Assist the team in functional training initiatives.
• Build and maintain strong connections and relationships with Contract Research Organizations, Toxicologists and Consultants for Biological Risk Assessments as needed.

Education and Experience
• Bachelor’s Degree in Life Science/Biomedical Engineering or related field with minimal 6 years of experience in a scientific role in the medical device or pharma industry or Master’s degree (with thesis) in Life Science/Biomedical Engineering or related field with at least 4 years of experience in a scientific role in the medical device or pharma industry.
• Medical device, pharmaceutical or related experience or experience in a regulated environment with a proven record of success supporting patient safety studies for R&D projects is preferred.
• Significant experience and knowledge of medical device and combination product regulations
• Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations.
• Strong technical writing and verbal communication skills.
• Experience managing outsourced contract research (GLP, non-GLP, GMP activities).
• Strong familiarity with the product development process for medical devices or biologics
• Demonstrate critical thinking and problem-solving skills, including analysis and presentation of data.
• Self-motivated and proactive; ability to execute with minimal supervision and direction. Can work independently or part of a team.
• Ability to communicate complex technical information in a clear and easy-to-understand way (both verbally and in writing).
• Author internal reports and procedures as well as collaborating on manuscripts and abstracts for external submissions.
• Knowledge of Good Documentation Practices, maintain accurate documentation & related record retention documentation.
• Knowledge of Good Laboratory Practices (21 CFR, Part 58) and ISO-10993 standards .
• Proficient in required software including Word, Excel, PowerPoint, and Outlook, and statistical software]]> Fri, 10 Apr 2026 00:00:00 EDT 1
This position reports into the Packaging Engineering group under Combination Products Operations (CPO) in Thousand Oaks, CA. This position will apply engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. Knowledge of primary and secondary packaging systems and material science is essential to the position. The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. Day to day commercial support, and Lifecycle Management.

This position is responsible and accountable for the following:

• Support for testing and evaluation leading to recommendation and selection of primary and secondary packaging materials
• Familiarity with Material Testing standards, requirements and equipment is essential
• Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components
• Writing technical specifications, creating engineering drawings, and developing artwork templates
• Competent with AutoCAD, Illustrator, or similar software application to create, modify and approve engineering drawings
• Support line trials and packaging validation activities prior to introduction of any new or change in components/processes
• Collaborate with cross-functional teams (i.e. Quality, Device Engineering, Supply Chain, Artwork, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities

Qualifications: Masters degree OR Bachelors degree and 2+ years of engineering/scientific experience

Preferred Qualifications:

• BS Packaging, Mechanical Engineering, Chemical Engineering or Life Sciences
• 3+ years general packaging/engineering experience is strongly preferred
• Knowledge of primary and secondary packaging systems and material science is essential to the position
• The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment
• Independent problem solver with demonstrated skills working in teams or leading project teams
• Strong Interpersonal and communication skills]]> Thu, 09 Apr 2026 00:00:00 EDT 1
The ideal candidate is a hands-on Senior Scientist with strong experience in lab automation/robotics and/or molecular biology, capable of quickly stepping into an onsite role in a fast-paced protein engineering environment. This individual should demonstrate strong troubleshooting and workflow validation skills, along with high accountability, organization, and the ability to work independently. While a PhD is preferred, the manager is equally open to candidates with extensive industry experience who can hit the ground running. Experience with Hamilton scripting, Python, or NGS sequencing is a plus but not required. Given the short-term nature of the assignment, candidates must be comfortable with a contract role and able to work onsite consistently, with flexibility and speed being critical to success.

Job Post: We are seeking a highly motivated scientist. The ideal candidate will have a PhD and approximately 3-5 years of relevant experience, with a strong background in molecular biology and a balanced skill set spanning both wet-lab experimentation and data analysis. Experience with Bioinformatics and laboratory automation and robotics is essential. Familiarity with Hamilton scripting is highly desirable, and Python scripting is preferred but not required. Exposure to machine learning is a plus.

Key Responsibilities
-Plan, conduct, monitor, analyze, and document experiments with limited supervision.
-Follow established experimental designs and protocols to generate robust, reproducible, and reliable data.
-Adapt methods from the scientific literature for lab implementation and modify them as needed.
-Develop and implement new protocols with moderate review for automation integration.
-Interpret data (NGS sequencing data) and communicate findings clearly to the work group.
- Participate in scientific discussions and contribute to problem-solving efforts.
- Develop systems and practices to ensure high-quality data generation and organization.
- Operate, troubleshoot, and optimize standard laboratory equipment and major instruments/techniques.
- Resolve experimental and equipment-related issues effectively.
- Contribute to reports, presentations, publications, regulatory documents, invention disclosures, and/or patent submissions, as needed.
-Exercise sound judgment in determining when to work independently and when to seek input.

Basic Qualifications
PhD in Molecular Biology, Cell Biology, Bioengineering, Biotechnology, or a related scientific field.
Approximately 3-5 years of relevant experience in industry, academia, or postdoctoral research.
Strong background in molecular biology.
Experience independently conducting and troubleshooting laboratory experiments.
Ability to analyze, interpret, and communicate experimental data effectively.
Preferred Qualifications
Balanced experience in both wet-lab work and data analysis.
Hands-on experience with laboratory automation and robotic platforms.
Experience with Hamilton liquid handler scripting is highly desirable.
Python scripting experience is desirable, but not required.
Familiarity with automation workflows in a research or development environment is strongly preferred.
Exposure to machine learning is a plus.]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Japanese–English Interpreter (Engineering / CAPEX Project – Pharmaceutical Industry)
About the Role

We are supporting a large-scale CAPEX project for a global pharmaceutical manufacturing organisation, focused on the development of an Oral Solid Dosage (OSD) facility.

This role will be responsible for enabling clear and effective communication between Japanese and English-speaking teams across engineering, construction, and project delivery functions. You will work closely with cross-functional teams on-site, supporting day-to-day coordination and technical discussions throughout the project lifecycle.
 
Key Responsibilities

• Provide Japanese? English interpretation during meetings, site activities, and technical discussions
• Translate technical documentation and project materials
• Support communication between local contractors, vendors, and global project teams
• Assist international engineers and site personnel with day-to-day coordination
• Ensure all interpretation and translation is technically accurate and culturally appropriate
• Support general project coordination and administrative tasks as required

Requirements
Essential:

• Proven experience as a Japanese–English interpreter/translator within an industrial or engineering environment
• Strong understanding of technical terminology (mechanical, electrical, civil, or process engineering)
• Business fluent (or native) Japanese and English
• Comfortable working in a fast-paced, multicultural project environment
• Willingness to work on-site

Preferred:

• Experience supporting pharmaceutical or regulated manufacturing projects

]]> Thu, 09 Apr 2026 00:00:00 EDT 1 *depending on experience

SUMMARY OF ESSENTIAL FUNCTIONS:
• This position is responsible for the scheduling, processing, and auditing of clinical supply orders based on client request.
SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES INCLUDED BUT ARE NOT LIMITED TO:
• Coordinate and dispatch shipments of clinical trial material to clinical sites.
• Work with Project Management to define study specific distribution needs.
• Process orders, assemble folders (on-site and offshore generated).
• Audit folders for accuracy against customer requests and source documentation.
• Run reports to understand and coordinate workflow based on daily and weekly outlooks
• Ensure orders are processed and dispatched based on agreed turnaround time.
• Responsible for 95% completion of work to floor the day before and adhere to shift processing expectations set
by supervisor.
• Coordinate with Distribution Project Coordinators and support issues resolution solutioning.
• Coordinate destructions of existing material on site
• Create and maintain just in time labeling worksheets
• Maintain distribution group mailboxes and ensure shipments are scheduled accordingly.
• Support distribution execution group to resolve operational and document related issues.
• Work with Quality, IT, Inventory, and other supply chain functions to resolve issues regarding order processing.
• Coordinate with Import / Export Coordinator and Distribution Project Coordinator with international order
processing and documentation preparation.
• Responsible for Fedex and non-FedEx bookings, invoice creation and green light attainment.
• Understand and use source documentation i.e. Distribution Summary, Distribution Master Checklist in
conformance to Catalent Standards.
• Ensuring that clinical supplies are shipped in compliance with all applicable SOPs and in accordance with the
customer approved study specific Distribution Summary Protocol/Checklist.
• Acknowledge shipment is dispatched in IVRS when required.
• Generating shipment documents for the requested Clinical Trial Materials.
• Support / Review Commercial (proforma) Invoice templates in conjunction with Distribution Project Coordinators.
• Understand and adhere to all relevant standard operating procedures (SOPs) and GMP requirements.
• Perform related duties, special projects and/or other functions as required.
POSITION REQUIREMENTS:
• Required to have a high-level attention to detail while managing multiple projects and/or priorities under tight
deadlines.
• Strong computer skills are required – (including, but not limited to, Microsoft Word, Power Point, and Excel)
• Distribution and Supply Chain experience is preferred.
• Excellent written, verbal, and interpersonal communication skills are required.
• Ability to understand and process written and verbal instructions effectively.
• Demonstrate strong analytical skills and problem-solving skills
PHYSICAL REQUIREMENTS
• Able to walk, stand, and sit for an extended period of time depending on assigned task.
EDUCATION OR EQUIVALENT:
• High School Degree required with a minimum of 2-4 years of relevant industry experience.
• Associates Degree preferred]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Drive Customer Engagement and Lead Transformation as Our Next CRM Manager

Are you a seasoned CRM professional ready to make a significant impact? Join our dynamic team as a CRM Manager and play a pivotal role in shaping the future of our global CRM platform. This is a unique opportunity to lead operational excellence, collaborate with cross-functional teams, and drive innovative solutions in a fast-paced, innovative environment. If you thrive on strategic thinking, stakeholder management, and transforming CRM ecosystems, we want to hear from you!

What You’ll Do:

• Manage and optimize current CRM functionalities and data processes, ensuring the highest quality standards.
• Coordinate with master data teams to maintain accurate product access and data integrity.
• Maintain and improve CRM integrations with global customer databases, supporting seamless data flow.
• Gather and analyze business requirements for ongoing operations and future platform enhancements.
• Design and deliver comprehensive CRM training tailored to diverse user groups.
• Serve as a primary contact for internal and external stakeholders, aligning project objectives and timelines.
• Lead the transformation efforts towards a next-generation CRM platform, including process redesign and go-live preparations.
• Support a large user base (approximately 2,500–3,000 users) to ensure smooth CRM operations and user adoption.

Required Skills:

• 5+ years of proven experience in CRM management, ideally with Veeva and/or Salesforce systems.
• Deep understanding of CRM data processes and data quality management.
• Demonstrated experience in stakeholder management and cross-functional collaboration.
• Excellent communication skills with the ability to influence and lead teams informally.
• Strong project management, organization, and prioritization skills.
• Full professional proficiency in English.
• Operational mindset with the ability to support large user groups.
• Strategic, solution-oriented approach to complex challenges.

Nice to Have Skills:

• Experience within the pharmaceutical industry.
• Knowledge of AI-related systems or innovative technologies.
• Multilingual abilities (French or Dutch advantageous but not essential).
• Past involvement in large-scale transformation or migration projects.

Preferred Education and Experience:

• A relevant degree combined with extensive experience in CRM operations and platform transformation.
• A track record of successfully leading CRM projects in complex organizational environments.

This is an exciting chance to lead transformative projects and shape the future of our CRM landscape. If you’re ready to bring your expertise to a global team and make a tangible impact, apply now and take the next step in your career!
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Join a Dynamic Manufacturing Team as a Production Operator - II

Are you ready to play a vital role in the heart of Ireland's manufacturing industry? We are seeking a dedicated Production Operator - II to join a thriving team. This full-time, onsite position offers a fantastic opportunity to contribute to high-quality production processes within a cutting-edge facility, ensuring products meet the highest standards of quality and efficiency.

What You'll Do:

As a Production Operator - II, you will oversee key manufacturing and production operations, including assembly, machinery operation, processing, and packaging. You'll set and follow production schedules based on demand, equipment efficiency, material supply, and staffing. Your expertise will ensure that all preparatory and finishing work aligns with regulatory standards, maintaining strict quality controls in qualified production areas. This role requires moderate supervision and relies on your skills and knowledge to deliver consistent results.

Essential Skills:

• Proven experience in manufacturing or production environments
• Strong understanding of machinery operation and production processes
• Ability to read and interpret production schedules and technical instructions
• Attention to detail and commitment to quality standards
• Good communication and teamwork skills
• Ability to work safely and adhere to health and safety regulations

Nice to Have Skills:

• Previous experience in a regulated manufacturing environment
• Basic knowledge of GMP, ISO, or related standards
• Experience with automated machinery or processing equipment
• Forklift certification or other relevant process certifications

Preferred Education and Experience:

• Educational background in engineering, manufacturing, or related field preferred
• Prior experience working in a similar production role is highly desirable

If you are a motivated and skilled production professional eager to contribute to a leading manufacturing operation, we encourage you to apply now. Take your career to the next level and be part of a team committed to excellence!
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Job Summary

As part of our CMS Sales Team, you will be responsible for selling our non-invasive wearable cardiac defibrillator system, and other products such as our portfolio of cardiac diagnostic services to Health Care Professionals in the hospital and out of hospital setting. This includes the initial sales call as well as support activities to promote consistent use (Local Medical Education Programs, Tradeshows, clinical symposiums and conferences). Call points include: Physicians (Cardiologists, Electrophysiologists, Hospitalists, CT Surgeons etc.), Nurse Practitioners, Physician Assistants, nurses, case managers and administrators. Other duties include selling the value of the Patient Management System (ZPM) to clinicians as well as educating HCP's and staff about the types of patients indicated for a WCD and all essential ordering and billing requirements.

Essential Functions

 

• 
  Provide customers with relevant clinical data that supports the risk of Sudden Cardiac Death in certain patient types and the role of the WCD in protecting these patients
  
• 
  Provide customers with relevant clinical, reporting, and technical information that supports the utilization of Cardiac Diagnostic products for appropriate patients.
  
• 
  Responsible for sales and supporting activities to drive consistent utilization
  
• 
  Responsible for achieving assigned sales objectives
  
• 
  Responsible for selling the value of the Patient Management (ZPM) to clinicians as well as educating HCP’s and staff about all essential ordering and billing requirements for the WCD
  
• 
  Maintain database of accounts, prepare and submit reports
  
• 
  Maintain a yearly and quarterly business plan
  
• 
  Manage field expenses and submit reports in a timely manner
  
• 
  Attend key Medical Education Programs, exhibits and conventions
  
• 
  Become a company expert and resource on both products and relevant industry trends
  
• 
  Master both Customer Centric Selling and Integrity Selling skills
  
• 
  Maintain a collaborative and professional working relationship with all business partners
  
• 
  Represent  in a professional and ethical manner. Always maintain a positive attitude
  
• 
  Communicate openly and share information with others
  
• 
  Analyze and report on trends that you observe within your territory
  
• 
  Ensure all relevant information and documentation is provided to intake and reimbursement to ensure appropriate and timely filing of billing claims
  
• 
  Maintain credentialing/access to all assigned accounts at all times
  

Required/Preferred Education and Experience

• 
  Bachelor's Degree From four-year college or university required
  
• 
  3-5 years sales experience in medical equipment sales or specialized/hospital based pharmaceutical sales or 5 years of successful sales experience, with at least one of those years in healthcare sales required
  
• 
  Cardiology experience preferred
  
• 
  Valid state driver’s license Required
  

Knowledge, Skills and Abilities

• 
  Ability to be credentialed/have access privileges in all assigned customer accounts.
  
• 
  Documented history of sales success
  
• 
  Proficient with Microsoft Office Suite
  
• 
  Must live within the assigned territory
  
• 
  Internal candidates that do not meet the sales experience criteria above may be hired if they have demonstrated a sustained ability to meet the expectations of a sales role and have been in a sales support role for a minimum of 1 year OR have successfully performed within a Associate Territory Manager role.
  

Physical Demands

• 
  This position requires the employee to sit, stand, walk, talk, listen, hear and speak on a regular basis. May occasionally be required to stoop and bend.
  
• 
  Must be able to drive an automobile and may be required to travel by train or airplane as needed.
  

Working Conditions

• 
  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
• 
  This job is a field-based position. Employee will be responsible for working daily in hospitals, doctors’ offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs.
  

]]> Thu, 09 Apr 2026 00:00:00 EDT 0 *Depending on experience

As the candidate for this largely laboratory-based position, you will be responsible for driving cutting-edge analytical support and technology development impacting process and product development teams. You will work cross-functionally and across Process Development sites as you use analytical science to help drive efficient development and scalable understanding of processes and products.

Minimum Basic Qualifications
Master’s degree
OR
Bachelor’s degree and 2 years of experience
OR
Associate’s degree and 4 years of experience
OR
High school diploma / GED and 6 years of experience


Preferred Qualifications
* Master's degree in Analytical Chemistry, Physical or Pharmaceutical or Life Sciences or Engineering related discipline.
* Strong theoretical understanding, research in, and hands-on experience in small molecule/peptide analysis in support of process development/scale up activities and formulation development in GMP and non-GMP environments
* Experience with a broad array of chromatographic and spectroscopic techniques.
* Demonstrate independence and ability to produce quality results under minimal direction
* Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook
* High energy individual who can multi-task and handle a fast-pace, dynamic work environment
* Operate specialized laboratory equipment and instrumentation
* Perform general laboratory housekeeping activities
* Complete training on assigned tasks
* Comply with safety guidelines and site specific procedures which include but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books]]> Thu, 09 Apr 2026 00:00:00 EDT 1 'The main issue was we needed someone who thinks like an engineer and willing to focus on secure product design, documentation, and maintaining the security of the devices. I think we end up with a lot of security IT people who are used to monitoring network infrastructure and things like that vs. thinking about building a product with secure features.'

HM's Top Need:

1. Background in security (education and/or certifications)
2. Willingness to create and maintain documentation
3. Excellent communication skills and willingness to work with less technical team members to understand security concepts

Education Required: Bachelors
Years’ Experience Required: 2

Location: Lafayette, Colorado – 4 days in office per week.

Education Required: Bachelor's degree related to computer science or cybersecurity

Years’ Experience Required: 2 or more

Title: Cybersecurity Specialist

Job Description:

The Acute Care & Monitoring group develops products that are designed to collect patient information from around the hospital and ensure that caregivers can make the right decisions at the right time. We strive to improve patient outcomes by ensuring that when a problem emerges at the bedside, caregivers are aware of it and can respond quickly. We analyze and learn from patient data to find better ways to provide quality care for patients. Our products are deployed in care facilities across the globe and help to save and improve lives every day. A career here is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.

This position is primarily responsible for supporting pre-market project teams in building security deliverables.  You will work with R&D teams to help them understand how to build products securely by design and how to maintain their security for their product lifetime.

 Top 3 Tasks or Responsibilities in scope for this role:

1. Working with medical device product teams to build security deliverables and documentation
2. Building and updating SBOMs
3. Building threat models for medical devices

 Top 3 things the manager is looking for in a candidate:

1. Experience with threat modeling
2. Experience with SBOMs (Software Bill of Materials)
3. Experience with CVSS scoring

 Travel: N/A

Position Responsibilities:

-Build threat models for products and assess threats for risk and possible mitigations

- Build SBOMs for products and review their accuracy

- Review and interpret CVEs for impact on products

- Review and interpret penetration testing results

- Work with technical experts and product owners to measure risk associated with vulnerabilities

- Document risk assessments

- Recommend mitigations for security risks

 

Minimum Qualifications:

- Bachelor’s degree in computer engineering, software engineering, cybersecurity, computer science, or related field

- 2 years of experience in a cybersecurity-related role

- Experience with networking concepts

- Effective communication both verbally and in written form

- Experience with threat modeling tools, such as Microsoft Threat Modeling Tool

- Experience with vulnerability monitoring tools such as Dependency-Track

- Experience with using the NVD

- Familiarity with the CycloneDX SBOM specification

- Experience with CVE interpretation

- Experience with CWE interpretation

- Experience with CVSS scoring methodology

- Experience explaining technical concepts to non-technical individuals

- Familiarity with FDA Pre and Post-market guidance

- Familiarity with the OWASP Top 10

- Familiarity with standards such as IEC 81001-5-1 and IEC 62304
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Job Summary

As a valued member of our North American Sales management team, this individual will be responsible for the direct management of CMS Territory Managers (sales representatives) and Sales Associates within an assigned region.

Essential Functions

• Manages medical equipment sales activities and is responsible for planning, organizing, and implementing sales programs for the assigned region.
• Engages with key accounts and builds relationships throughout the region.
• Responsible for consistently meeting or exceeding region performance objectives, including order counts, booked revenue quotas and profit.
• Maintain a positive attitude, control discounts and expenses to contribute positively to our profitability.
• Hires, educates, retains and promotes talented sales professionals.
• Foster a team environment within your region. Lead by example, motivate and inspire your team.
• Communicate, implement, and monitor the CMS Strategic Plan.
• Develop Territory Managers through coaching and positive reinforcement.
• Spend an average of four days per week working in the field with your TM''s.
• Manage and assess Territory Managers adherence with regional expectations to improve performance. Become a company expert and resource on both internal and competitive landscape.
• Responsible for field reinforcement of products and positioning strategy.
• Represent company in a professional and ethical manner.
• Communicate openly and share information with others.
• Analyze and report on trends that you observe within your region.
• Directly supervises Territory Managers in the field. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Required/Preferred Education and Experience

• Bachelor's Degree required
• At least three (3) years of field sales experience – client focus within cardiology, medical device and/or pharma industries required
• Five or more years of experience in medical equipment sales management – preferably cardiology. Demonstrated business acumen within the medical industry.

Knowledge, Skills and Abilities

• Proven sales leadership.
• A valid driver’s license

Travel Requirements

• 60% This job is a field-based position and requires that you reside within the assigned Region. Employee will be responsible for working daily in hospitals, doctors’ offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs. This position will require at least 60% travel. Travel may be outside the local area and overnight and could be for an extended period.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Occasionally
• Lifting - Occasionally
• Talking - Occasionally
• Hearing - Occasionally

]]> Thu, 09 Apr 2026 00:00:00 EDT 0 Job Summary

As part of our CMS Sales Team, you will be responsible for selling our non-invasive wearable cardiac defibrillator system, and other products such as our portfolio of cardiac diagnostic services to Health Care Professionals in the hospital and out of hospital setting. This includes the initial sales call as well as support activities to promote consistent use (Local Medical Education Programs, Tradeshows, clinical symposiums and conferences). Call points include: Physicians (Cardiologists, Electrophysiologists, Hospitalists, CT Surgeons etc.), Nurse Practitioners, Physician Assistants, nurses, case managers and administrators. Other duties include selling the value of the Patient Management System (ZPM) to clinicians as well as educating HCP's and staff about the types of patients indicated for a WCD and all essential ordering and billing requirements.

Essential Functions

 

• 
  Provide customers with relevant clinical data that supports the risk of Sudden Cardiac Death in certain patient types and the role of the WCD in protecting these patients
  
• 
  Provide customers with relevant clinical, reporting, and technical information that supports the utilization of Cardiac Diagnostic products for appropriate patients.
  
• 
  Responsible for sales and supporting activities to drive consistent utilization
  
• 
  Responsible for achieving assigned sales objectives
  
• 
  Responsible for selling the value of the Patient Management (ZPM) to clinicians as well as educating HCP’s and staff about all essential ordering and billing requirements for the WCD
  
• 
  Maintain database of accounts, prepare and submit reports
  
• 
  Maintain a yearly and quarterly business plan
  
• 
  Manage field expenses and submit reports in a timely manner
  
• 
  Attend key Medical Education Programs, exhibits and conventions
  
• 
  Become a company expert and resource on both products and relevant industry trends
  
• 
  Master both Customer Centric Selling and Integrity Selling skills
  
• 
  Maintain a collaborative and professional working relationship with all business partners
  
• 
  Represent  in a professional and ethical manner. Always maintain a positive attitude
  
• 
  Communicate openly and share information with others
  
• 
  Analyze and report on trends that you observe within your territory
  
• 
  Ensure all relevant information and documentation is provided to intake and reimbursement to ensure appropriate and timely filing of billing claims
  
• 
  Maintain credentialing/access to all assigned accounts at all times
  

Required/Preferred Education and Experience

• 
  Bachelor's Degree From four-year college or university required
  
• 
  3-5 years sales experience in medical equipment sales or specialized/hospital based pharmaceutical sales or 5 years of successful sales experience, with at least one of those years in healthcare sales required
  
• 
  Cardiology experience preferred
  
• 
  Valid state driver’s license Required
  

Knowledge, Skills and Abilities

• 
  Ability to be credentialed/have access privileges in all assigned customer accounts.
  
• 
  Documented history of sales success
  
• 
  Proficient with Microsoft Office Suite
  
• 
  Must live within the assigned territory
  
• 
  Internal candidates that do not meet the sales experience criteria above may be hired if they have demonstrated a sustained ability to meet the expectations of a sales role and have been in a sales support role for a minimum of 1 year OR have successfully performed within a Associate Territory Manager role.
  

Physical Demands

• 
  This position requires the employee to sit, stand, walk, talk, listen, hear and speak on a regular basis. May occasionally be required to stoop and bend.
  
• 
  Must be able to drive an automobile and may be required to travel by train or airplane as needed.
  

Working Conditions

• 
  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
• 
  This job is a field-based position. Employee will be responsible for working daily in hospitals, doctors’ offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs.
  

]]> Thu, 09 Apr 2026 00:00:00 EDT 0 Target PR Range: 57-67/hr
*Depending on experience

Project Manager I (non IT)
Responsible for coordinating, planning, and executing Eye Care brand team initiatives and projects within IMCO. The Project Manager will manage timelines, resources, and communications to ensure project goals are achieved on time and within budget. This role is also accountable for creating and maintaining a strong governance process to track project progress, ensure compliance, and drive accountability across all team activities.

Key Responsibilities:
• Lead and coordinate Eye Care brand team projects, delivering initiatives on-time and within budget. Ensure all projects align with IMCO standards, with regular monitoring and reporting against these key success criteria.
• Develop, implement, and maintain a robust governance process, prioritizing performance tracking for both financial and strategic imperatives.
• Manage budget processes (monthly forecasts, purchase orders, and vendor management).
• Oversee and enhance internal communications, manage team portals/sites and key documentation for easy access.
• Drive process improvements and support the implementation of modular content marketing plans in partnership with ACE and Marketing.
• Manage and maintain the Eye Care team calendar of events to coordinate activities and ensure alignment with key milestones and deliverables.

Qualifications
• 5+ years of project/program management experience, preferably in healthcare or related industries.
• Strong project management and financial (budget) acumen.
• Proven internal communication and stakeholder management skills.
• Experience with digital tools and project management platforms (e.g., SmartSheet, Content Management Systems).
• Demonstrated ability to establish governance processes and keep projects on track.
Success Criteria:
• Effective, on-time, and within-budget delivery of Eye Care projects.
• Strong, transparent governance with regular progress tracking and reporting.
• Positive collaboration across cross-functional teams.
• Compliance with all IMCO policies and procedures.
]]> Thu, 09 Apr 2026 00:00:00 EDT 1
Basic Function:
This position contributes significantly to the successful timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying out required preformulation, formulation and process activities.

Specific Activities, and Responsibilities:

• Responsibility for the maintenance and cleaning of laboratory instruments and equipment; maintaining the laboratory in a clean and organized state
• Maintains inventory of glassware, chemicals, reagents, raw materials/excipients, consumables, media and materials needed for preformulation and formulation activities
• Disposes of hazardous waste according to environmental regulations and company/ departmental procedures.
• Receive, label and store receipts of solvents and other analytical reagents.
• Prepares reagents, standards, media, etc. needed for analysis
• Sets up, uses and cleans isolator
• Supports preparation of solubility, compatibility samples
• Sets up, operates and cleans mixers, laboratory scale encapsulation machine, coating pan and/or other equipment
• Prepares laboratory fill mixes
• Prepares gel swatches
• Executes drying studies
• Washes, inspects and packages laboratory batches
• Performs fill moisture, water activity, hardness, fill and shell weight, rheology, burst strength, impact/drop testing, disintegration and/or other testing
• Records the results in approved notebooks, batch records, reports and logbooks.
• Washes glassware used to perform analysis if needed
• Ships samples to customers (animal PK samples, airfills, etc.) as needed
• Files and maintains laboratory records
• May provide training to new or existing personnel
• Required to read and execute departmental guidance and SOPs.
• Performs other miscellaneous duties as required
• May be required to work with highly potent compounds, hormones.

Knowledge Requirements:

Education or Equivalent:
• Requires High School education, and preferably with some college course work in related sciences.
• Prefer prior experience in a laboratory setting.
• Must possess good interpersonal skills.
• Ability to effectively communicate with co-workers.
• Good organizational skills required

Knowledge/Skills Requirements:
• Must have accurate and legible documentation skills
• Knowledge of software applications (MS Word and Excel)
• Experience with analytical equipment (balances) preferred
• Required to use laboratory equipment

Physical/Mental Requirements:
• Ability to work effectively under pressure to meet deadlines
• Ability to stand, walk and reach regularly.
• Individual is required to sit, stand, walk, stoop, kneel, crouch regularly and lift to 40 pounds; no lifting greater than 44.09 pounds without assistance.
• Can access laboratory, office areas and manufacturing with ability to comply with gowning requirements.
• Can use required laboratory and office equipment
• Vision requirements include reading of written documents and frequent use of a computer monitor.
• Vision requirements include ability to differentiate color, have 20/30 vision with or without corrective lenses, read written documents and frequent use of a computer monitor.]]> Thu, 09 Apr 2026 00:00:00 EDT 1 • Lead end to end program management for CLIA based diagnostic initiatives, including IUO assay design and development, analytical verification, assay transfer, and CLIA validation.
• Drive Design Control rigor across design inputs/outputs, risk management, traceability, design reviews, and Design History File (DHF) readiness in alignment with established TM QMS.
• Partner with Pathology/IHC, Molecular Diagnostics, Device Quality, Regulatory Affairs, and Lab Compliance to ensure compliant and timely clinical enablement.
• Integrate diagnostic strategies into clinical protocols to support patient stratification and early development decision making.

Bioanalysis Program Management (GLP)
• Coordinate GLP compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies, including oversight of assay timelines, critical reagents, data transfers, and CRO deliverables.
• Ensure alignment of bioanalytical execution with IND enabling and clinical milestone expectations, in partnership with Regulatory and QA.
• Proactively manage interdependencies between diagnostics and bioanalysis where programs require coordinated execution.
• Provide program management for GLP quality execution, including inspection readiness, audit/inspection coordination, and CAPA governance in partnership with QA and study teams as needed

Quality, Compliance & Data Integrity
• Operationalize QMSR/21 CFR 820, GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11 requirements across laboratory operations, vendors, and data flows.
• Enforce Good Documentation Practices (GDP) and ALCOA/ALCOA+ principles across sample, method, and data lifecycles.
• Maintain inspection ready execution through disciplined documentation, validated systems (LIMS/EDMS), and audit ready records.
External Partnerships & Vendor Oversight
• Serve as the primary program interface with CROs, CLIA laboratories, IVD/CDx partners, and specialty vendors.
• Define scopes of work, timelines, and deliverables; manage risks, issues, and escalations with a patient impact lens.
• Ensure vendors meet quality, compliance, and performance expectations.
Program, Portfolio & Financial Management
• Build and manage integrated project plans, risks, and dependencies across diagnostics and bioanalysis.
• Track timelines, forecast resources, and support budget visibility for program leadership.
• Provide concise, decision focused updates to stakeholders and leadership; escalate risks early with data backed mitigation options.
Ways of Working & Culture
• Model Behaviors: Urgency & Agility, Accountability, Innovation, Integrity, and Passion for Excellence.
• Simplify interfaces, reduce operational friction, and apply data driven and AI enabled workflows where appropriate to accelerate execution.

Qualifications
Required
• Bachelor’s degree in a scientific or engineering discipline; MS preferred.
• 6+ years of experience in GxP regulated environments, spanning Precision Medicine / Diagnostics and/or Bioanalysis.
• Hands on experience with Design Control execution for IVD/CDx or IUO assays.
• Strong working knowledge of FDA QMSR (21 CFR 820), GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11.
• Proven ability to lead complex, cross functional programs in matrixed organizations.  
Pay Rate Range: $55.00 - $61.00/hr/hr depending on experience ]]> Thu, 09 Apr 2026 00:00:00 EDT 1 *depending on exp

PV Scientist serves as a product lead for Pharmacovigilance activities within Safety. The PV Scientist may be responsible for overseeing day to day safety operations of clinical trials for the assigned product(s), supporting and/or leading the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings) and RMPs, responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV activities. The PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information.

What You’ll Do
Support and/or leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Support and/or leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
Support and/or leads process for responding to safety questions from regulatory authorities while collaborating with cross-functional team as necessary.
Support and/or leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Plans (REMS), and Risk Management Plans (RMPs).
Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned to ensure alignment with safety strategy and risk communications.
Responsible for day-to-day safety operations and safety management plans for assigned clinical trials

Qualifications Required Skills
Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management experience.
Bachelor’s Degree in biologic or natural science; or health case discipline required. Advanced degree (PhD, MPH, NP, PharmD, etc.) preferred.
Knowledge of MedDRA terminology and its application
Must have excellent analytical and problem-solving ability
Strong computer skills and advanced application MS capability desirable, particularly Excel
Ability to work in fast-paced environment with multiple competing priorities]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Thu, 09 Apr 2026 00:00:00 EDT 1
JOB DESCRIPTION

The selected candidate will work in the Separations and Biophysical Assays team within the Analytical Sciences group to assist in the advancement of the company's therapeutics for clinical evaluation and potential commercialization. The candidate will be responsible for method development (separations), provide routine testing and characterization support to partner groups to help with early candidate selection, process development, and drug substance and drug product process characterization. The ideal candidate will have hands-on experience working with biologics including but not limited to proteins, peptides, protein-conjugates, enzymes, biologics with a focus on method development and in-depth characterization. The ideal candidate will be able to perform quality work under limited supervision, apply problem solving techniques to maintain accurate results, promote improvements, and assure a safe, stable, on-target operation within the laboratory. The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment.

RESPONSIBILITIES

Primary responsibility is to support the Separations and Biophysics group within Analytical Sciences

Be a hands-on presence in the laboratory, supporting biophysical/ biochemical assay development and qualification using HPLC and CE (must have) for various modalities (preferably biologics). LC-MS (high-res) experience is also desirable.

Provide routine analytical characterization & testing support to partner groups including Upstream and Downstream PD, Formulations, and Research & Early Development (RED).

Document experimental results in the company electronic lab notebook (Benchling), author procedures, and contribute to technical documentation (test methods, development reports).

Actively participate in the operational aspects of the laboratory by conducting safety inspections, lab organization, ordering supplies, and performing routine equipment maintenance.

Present scientific literature and results from ongoing studies at group meetings and other discussion forums at the company.

Other duties as assigned.

Skills

Required Skills:

Hands-on experience in the biotechnology industry or academic setting with a broad range of analytical techniques focused on analytical testing and characterization for proteins, peptides, and protein-conjugates is required.

Experience with biochemical characterization methods is required:

SEC, SCX, RP-HPLC experience is a must (Agilent/Waters/Thermo LC instruments)

Capillary Electrophoresis (PA800 or BioPhase8800) based methods (SDS for size separation, glycan profiling)

cIEF (Maurice) experience is highly desirable

LC-MS (Orbitrap/QToF/QQQ) method development experience also desirable

Technical understanding of all aspects of analytical testing, phase appropriate regulatory requirements, method qualifications, and method transfers.

Ability to independently troubleshoot issues, ideate, and develop insights into technical challenges and propose solutions to solve them.

Demonstrates attention-to-detail and “right-the-first time’ approach

Excellent written and oral communication skills, with the ability to communicate complex information. Be able to present data/ideas to functional and cross-functional teams.

Ability to influence others effectively and develop collaborative relationships with partner teams.

Familiar with use of statistical software, electronic document management, and laboratory information management.

Ability to effectively analyze complex problems and present results effectively within and beyond the department

Ability to flexibly adapt to changing business needs and meet timelines.

Strong organizational skills with the ability to effectively multi-task and prioritize.

Desired Skills:

Experience in method development, qualification, and transfer to/from other laboratories such as development, quality control.

Knowledge of biopharmaceutical process development is a plus.

Experience with automation is a plus.

Experience working in a cross-functional environment.

Good understanding of root cause analysis methodology.

Education

Bachelor’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 6+ years of experience in a Biologics or Pharmaceutical environment.

Master’s degree in Chemistry, Biochemistry, Analytical Chemistry, Chemical Engineering or a related field with 4+ years of experience in a Biologics or Pharmaceutical environment.
 ]]> Thu, 09 Apr 2026 00:00:00 EDT 1 POSITION OVERVIEW:
Working on implementing and managing analytical activities to support new product development, formulations, and early-stage clinical studies.

The associate scientist, under the supervision of a lead scientist, will contribute to developing and executing analytical test methods in a laboratory environment. The associate scientist will also be required to document experiments, analyze data sets, and prepare reports.

This position is expected to communicate data both verbally and through written documents and technical reports and be able to comfortably multitask across projects and disciplines.

RESPONSIBILITIES:
• Operate and maintain analytical equipment such as HPLC/UPLC, FTIR, Dissolution, UV-Vis Spectrophotometer etc., and other common analytical instruments used to determine potency, purity, and in-vitro performance of drug substance and drug product.
• Perform routine testing of samples, generate and analyze data in alignment with project goals.
• Contribute to experimental design, support troubleshooting, optimization and data analysis as needed.
• Utilize a scientific background to support analytical method development and validation under supervision.
• Support a safe, organized, and operational laboratory environment, including coordination of equipment calibration/maintenance, procurement of supplies, etc.
• Maintain timely and accurate laboratory records consistent with good documentation practices.
• Effectively communication with team members and ensuring GLP compliance and adherence to safety standards.

Requirements Qualifications:
1-2 years of experience in the following is required:
• Scientific background in analytical laboratories, and experience in operating high performance liquid chromatography (HPLC).
• Hands-on knowledge of chemical analysis principles, chromatographic theories and technologies.
• Analytical, meticulous, highly organized, and able to analyze data and implement solutions.
• Excellent communication skills and be comfortable in a team-oriented environment.

EDUCATION:
Bachelors degree in Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or other relevant scientific field, and a minimum of 1-2 years related experience.

Pay $26-33 based on experience level
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 CQV Manager (Commissioning, Qualification & Validation)
About the Role

We are supporting a large-scale greenfield pharmaceutical manufacturing project and are seeking an experienced CQV Manager to lead commissioning, qualification, and validation activities across the project lifecycle.

This role will oversee CQV strategy, execution, and compliance, working closely with engineering, EPC contractors, and cross-functional project teams to ensure timely and high-quality delivery.
Key Responsibilities

• Lead and manage all CQV activities across the project lifecycle
• Develop and execute CQV strategy, plans, and reporting aligned to project requirements
• Oversee EPC contractor deliverables, ensuring alignment with project scope, timelines, and quality standards
• Review and manage engineering documentation (PFDs, P&IDs, layouts, equipment specs, etc.)
• Ensure compliance with GMP, GEP, and validation standards across all systems
• Act as SME for validation strategy, including computerized systems and automation
• Coordinate qualification and validation activities, ensuring documentation and traceability
• Manage project interfaces across engineering, quality, and operations teams
• Monitor project progress, identify risks, and implement corrective actions
• Support inspections, audits, and handover to operations

Requirements
Essential:

• Degree in Engineering, Life Sciences, or related technical field
• 7+ years’ experience in CQV within pharmaceutical or life sciences manufacturing
• Strong experience with equipment and system qualification
• Deep understanding of GMP, validation lifecycle, and engineering quality processes
• Fluent English
• Ability to operate in complex, cross-functional project environments

Preferred:

• Japanese language capability
• Experience on large-scale CAPEX or greenfield projects
• Exposure to automation systems and computerized system validation

Summary
This is a high-impact role on a major pharmaceutical build, offering the opportunity to lead CQV delivery on a complex, large-scale project in a highly regulated environment.
]]> Thu, 09 Apr 2026 00:00:00 EDT 1
This role is highly execution-oriented and requires strong program management discipline, systems fluency (SAP, Ariba, contract lifecycle tools), and the ability to design pragmatic interim processes that evolve into steady-state operating models.

Key Responsibilities
Integration Planning & Program Management

• Design and own the procurement integration roadmap, including Day 1 readiness, interim state, and steady-state transition milestones.

• Develop and maintain detailed timelines of activities, dependencies, and decision points across supplier onboarding, contracting, PO/invoicing, and system cutovers.

• Identify critical path items and risks (e.g., employee wave transitions, invoice approval gaps, supplier ownership changes) and proactively drive mitigation plans.

• Coordinate with the Integration Management Office (IMO) to align procurement activities with broader integration waves and change milestones.

E2E Procurement Process Design
• Design and document end-to-end procurement workflows (Source-to-Contract, Procure-to-Pay) tailored to integration scenarios.

• Create swimlane process maps that clearly define roles and responsibilities across:
o Legacy entity stakeholders
o New parent/company stakeholders
o Procurement
o Finance / FP&A
o Legal / Legal Ops
o AP / Shared Services

• Define differentiated workflows for:
o Existing vs. new suppliers
o Existing vs. new spend
o Expedited / critical supplier scenarios
o Dual-system environments

Cross-Functional Governance & Decision Enablement
• Establish clear decision frameworks for retain / terminate / amend contracts and suppliers.
• Ensure business ownership is explicitly assigned for suppliers, contracts, POs, and invoice approvals at every stage of the integration.
• Facilitate cross-functional alignment sessions to drive timely decisions on:
o Budget approvals
o Spend thresholds and escalation paths
o Contract ownership transitions
o Supplier communication timing and messaging
o Additional identified dependencies

• Act as a neutral facilitator to resolve ambiguity where ownership, authority, or policy interpretation is unclear.

Supplier & Contract Transition Management
• Partner with Procurement, Legal, and business stakeholders to:
o Identify critical suppliers and contracts
o Support contract review, amendment, termination, or novation activities
o Coordinate bulk uploads into contract lifecycle systems
• Oversee supplier communication plans related to acquisition notices, onboarding changes, and billing updates.
• Ensure continuity of supplier performance management during ownership transitions.

Systems & Controls Enablement
• Design and coordinate procurement system strategies during integration, including:
o Interim dual-system operations
o Supplier and PO transition timing
o Controls to prevent payment disruption

• Partner with Finance and AP to define interim approval documentation and audit-ready controls.
• Support reconciliation and reporting requirements across systems during transition periods.

Documentation, Training & Change Enablement
• Produce clear, reusable integration artifacts, including:
o Process overviews and playbooks
o Role-based guidance for business stakeholders
o Approval matrices and escalation models
• Support training for managers, IMO partners, and procurement contractors on new or interim workflows.
• Capture lessons learned and continuously improve integration templates and standards.

Required Qualifications
• 8+ years of experience in procurement, sourcing, finance operations, or transformation roles
• Demonstrated experience leading complex, cross-functional programs (M&A integration experience is required
• Deep understanding of Source-to-Pay / Procure-to-Pay processes
• Hands-on experience with procurement and finance systems (e.g., SAP, Ariba, NetSuite, contract lifecycle tools)
• Strong ability to translate ambiguity into structured plans, workflows, and decisions
• Excellent stakeholder management, facilitation, and communication skills

Success Measures
• Day 1 readiness achieved with no disruption to critical suppliers or payments
• Clear, adopted E2E workflows with documented ownership and approvals
• Timely contract and supplier transition decisions aligned to integration waves
• Reduced operational risk and rework during system cutovers
• Positive stakeholder feedback on clarity, execution, and decision enablement

Working Style & Mindset
• Highly organized, detail-oriented, and comfortable operating in ambiguity
• Pragmatic problem-solver who balances policy adherence with business continuity
• Collaborative leader who builds trust across Procurement, Finance, Legal, and the business
• Continuous improvement mindset with a focus on reusable integration standards

Pay ranges between 88-93/hr based on experience ]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Responsible for supporting the development, integration, improvement, and maintenance of complex custom automation systems in a regulated biotechnology environment. This role applies advanced engineering knowledge across mechanical, electrical, and software domains to ensure reliable system performance, regulatory compliance, and effective troubleshooting. Working independently within defined project objectives and quality standards, the role collaborates with cross functional teams to support system verification and validation, resolve complex technical issues, and contribute to successful product development.

DUTIES AND RESPONSIBILITIES:
• Apply advanced engineering principles to support the design, integration, and operation of custom automation systems, including hardware and software components.
• Understand system requirements, operational scenarios, and success criteria, and contribute to system level integration efforts to ensure reliable interoperability.
• Support verification and validation activities, including functional testing, to confirm systems meet defined requirements and quality standards.
• Troubleshoot complex automation issues, perform root cause analysis, and implement effective corrective actions in environments where system uptime is critical.
• Develop, maintain, and update engineering documentation, system specifications, test protocols, and technical reports in accordance with internal quality processes.
• Ensure compliance with applicable industry standards, regulatory requirements, and internal procedures, including GxP principles and FDA regulations as applicable.
• Collaborate with cross-functional teams, stakeholders, and key opinion leaders to ensure seamless integration and successful project delivery.
• Continue to build technical expertise through mentorship, training, and exposure to the full product development lifecycle.

EDUCATION AND EXPERIENCE:
• Bachelor’s degree in Engineering, or a related engineering discipline.
• Minimum 5 years of relevant experience in automation engineering, hardware design, or a biotechnology or regulated industry environment.
Experience with liquid handling equipment and processes

Pay $55-70/hr based on experience level]]> Thu, 09 Apr 2026 00:00:00 EDT 0 Übernehmen Sie eine zentrale Rolle im Ausbau innovativer kardiovaskulärer Lösungen und unterstützen Sie Kliniken in ganz Österreich bei der Einführung und Anwendung moderner TAVI? und Koronartherapien. In dieser strategischen und klinisch geprägten Vertriebsposition arbeiten Sie eng mit Herzkatheterlaboren, Kardiologieabteilungen und relevanten Entscheidungsträgern zusammen.
Ihre Aufgaben

• Betreuung Ihres Vertriebsgebiets mit Fokus auf TAVI? und Koronarprodukte; Weiterentwicklung etablierter Zentren sowie Identifikation neuer Marktchancen.
• Durchführung klinischer, technischer und kommerzieller Gespräche zur Positionierung des Portfolios in interventionellen Kardiologien und strukturellen Herzzentren.
• Aufbau und Pflege langfristiger Beziehungen zu Ärztinnen und Ärzten, Pflegepersonal, Medizintechnikerinnen und?technikern, Einkaufsteams sowie weiteren Stakeholdern.
• Unterstützung klinischer Abläufe im Herzkatheterlabor und kompetente Begleitung von Anwendungen während Eingriffen.
• Analyse regionaler Marktpotenziale und Umsetzung gezielter Verkaufsstrategien zur Erreichung definierter Wachstumsziele.
• Planung und Durchführung von Produktschulungen, Workshops und klinischen Education?Sessions.
• Repräsentation des Unternehmens auf Fachkongressen, Veranstaltungen und regionalen Events.
• Strukturierte Dokumentation im CRM sowie aktives Pipeline?Management.
• Eigenständige Organisation Ihrer Reisetätigkeit innerhalb Österreichs.

Ihr Profil

• Klinischer oder medizintechnischer Hintergrund, idealerweise mit Erfahrung im Herzkatheterumfeld oder in kardiovaskulären Therapien.
• Mehrjährige Vertriebserfahrung in der Medizintechnik, vorzugsweise in komplexen oder prozeduralen Bereichen.
• Hohe kommunikative Kompetenz und Fähigkeit, nachhaltige Beziehungen auf allen Hierarchieebenen aufzubauen.
• Bereitschaft und Routine, klinische Verfahren operativ zu begleiten und im prozeduralen Umfeld sicher aufzutreten.
• Selbstständige, proaktive und lösungsorientierte Arbeitsweise mit klarer Ergebnisorientierung.
• Organisationsgeschick und strukturierter Arbeitsstil.
• Sehr gute Deutschkenntnisse; gute Englischkenntnisse für internationale Zusammenarbeit.
• Reisebereitschaft innerhalb Österreichs.

]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Description 
The Senior Manager/ Associate Director, Engagement Platforms and Reporting will support roadmap, implementation and maintenance of technology platforms and measurement reporting for Medical Engagement activities across Global Medical Affairs (GMAF). He/she will support functional Medical Engagement Leads with platform implementation and ongoing maintenance with emphasis on field medical related-systems. Additionally, he/she will implement key measurement framework and reports across breadth of external engagements including field medical, congresses, society engagements, medical education, and other activities.

This role will sit within the Medical Engagement (ME) group as part of the larger Medical Excellence Team within GMAF. He/she will support the various Leads across Medical Engagements, partner closely with our commercial teams, Information Technology, and partner with GMAF colleagues, specifically from strategic markets, to maximize end user implementation. This role will maintain a focus on key strategic markets and assets / indications in line with company priorities.
 
Key areas of responsibility:

• Oversee the development, implementation, evaluation and maintenance of key platforms, systems, technology and associated trainings to support GMAF Medical Engagement
• Develop engagement measurement framework on key activities to enhance impact of medical affairs
• Lead reporting for GMAF with prioritization against GMAF needs and strategic capabilities
• Support GMAF roadmap execution through respective digital activities
• Manage vendor relationships and collaboration for project execution
• Ensure effective data capture across medical activities to quantify KPIs, metrics and overall impact
• Liaise with key stakeholders across medical affairs to ensure technology is enhancing user workflow and evolving ways of working
• Key point of contact with enterprise stakeholders including commercial digital, information technology, etc. to ensure alignment with enterprise level projects
• Manage project logistics including overall phasing, budget and resourcing throughout lifecycle
• Serve as single point of contact for digital platform, systems and technology needs
•  

 
Additional responsibilities may include:

• Working cross-functionally and collaboratively to communicate the ME priorities and roadmap internally; ensure alignment, coordination, and resourcing to execute the strategic plans with leadership and matrix teams appropriately
• Collaboration with the Medical teams and additional cross-functional internal stakeholders to create and initiate innovative strategies, programs, and tactics in alignment with the company's business objectives and specific therapeutic area strategic imperatives
• Develop partnership with internal and external stakeholders
• Collaborate cross-functionally across GMAF organization, regions/ countries, and enterprise partners

Qualifications (from An Accredited College Or University)

• 4+ years experience in a pharma / biotech preferred,
  • Key consulting or technology experience may be considered

• Experience in key Pharma / Biotech technology systems such as Veeva suite, Salesforce suite, etc. preferred
• Experience in measurement / reporting of medical affairs activities preferred
• Experience in project development and execution with IT, legal, compliance

• Demonstrated expertise in working successfully with cross-functional teams to achieve results preferred
• Scientific training (PharmD, PhD, or MD) optional

]]> Thu, 09 Apr 2026 00:00:00 EDT 1 --

The Data Entry Clerk, Manufacturing will work closely with all of the Manufacturing teams to understand and streamline Manufacturing production processes. This position will be responsible for processing production orders, creating labels for Quality Control (QC) samples and bulks made by the Manufacturing teams, working closely with inventory controllers to create Bin locations for purified and conjugated bulks and maintaining their accuracy, and reviewing, verifying, and scanning/attaching batch records into Enterprise Resource Planning (ERP) system. This position will also be responsible for helping the Inventory and Planning teams to resubmit re-test samples and will perform other duties as necessary.

Skills: 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

· Enter relevant manufacturing data into ERP systems to help complete production orders, and create production labels.

· Assist with batch records; review, verify, and scan batch records.

· Assist manufacturing teams with a variety of administrative tasks.

· Generate weekly and daily electronic reports

· File and maintain data printouts

· Maintain sample and controls inventories

· Perform job duties under ISO requirements and follow SOPs and/or work instructions

· Other projects or responsibilities as required.

Education: 

· High school diploma (or GED) with 6 months of data entry experience; Or

· Associates degree in a science or related field; Or

· Biotechnology Certificate

Preferred Qualifications:

· Prior hands-on experience with Microsoft Navision System (NAV) or other ERP systems

· Some academic or industry laboratory experience

· Basic understanding of manufacturing processes

 

Applicants must be currently authorized to work in the United States on a full-time basis for any employer.
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Can you please confirm your top 3 skills sets required?

• • Hands-on experience in mobile software development
  • Experience creating and managing backlogs, tracking execution, and driving delivery
  • Strong communication skills and ability to collaborate effectively across teams

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• • Own end-to-end delivery of an assigned mobile software release
  • Translate product features and requirements into structured, execution-ready backlogs and user stories
  • Track delivery metrics and drive execution discipline across development and test teams.

What is your target years of experience?  Bachelor’s degree in Software Engineering, Computer Science or equivalent with 5 to 8 years of managing delivery of advanced applications for mobile platform. 

 
TECHNICAL SKILLS
Must Have

• 2 years of experience writing Software, Java, Python, C
• Agile Metrics
• Agile Product Owner
• agile sprint
• Android
• Mobile Software Development
• Project Planning
• Software Project Management
• Technical Leadership
• technical software project management

Nice To Have

• DevOps tools like GitHub
  GitLab
  Kotlin
  Kotlin Multiplatform (KMM)
  PTC Codebeamer

 
Careers That Change Lives 

The Pelvic Health R&D team is one of the most cutting edge groups within the company, defining and executing on technology and architectural strategy using skills that span a variety of domains including Mobile Apps (Android), cloud, data analytics, web services, 2d/3d visualization, machine learning, and interfacing with embedded software for management and control of interconnected medical devices.

As a Senior Software Engineer (Project Engineer – Mobile), you will lead execution for a defined mobile software release pipeline, working with motivated, diverse, and knowledgeable development teams. You will collaborate with Product Engineering, Development, and Test Leads to translate requirements into actionable plans, create structured backlogs, and drive high-quality delivery. This role requires a mix of technical expertise, project execution, and leadership to deliver reliable, impactful mobile software that improves the quality of life of people around the world.
 

A Day in the Life 

• Own end-to-end delivery of an assigned mobile software release
• Translate product features and requirements into structured, execution-ready backlogs and user stories
• Lead backlog refinement, sprint planning, and overall release planning
• Approve and accept completed work in the ALM system using technical and quality judgment
• Apply technical judgment to evaluate approaches, challenge assumptions, and ensure architectural alignment and quality
• Partner with Product Engineering, Development, and Test Leads to ensure scope clarity, accurate task breakdown, and alignment with product intent
• Support prioritization discussions and maintain alignment with product strategy and system dependencies
• Identify risks and dependencies and drive mitigation plans
• Track delivery metrics and drive execution discipline across development and test teams
• Collaborate with stakeholders and communicate status, risks, and dependencies to leadership
• Ensure compliance with quality systems and software lifecycle processes
• Support regulatory deliverables in collaboration with engineering and test leads
• Promote engineering best practices and continuous improvement

 

Must Have: Minimum Requirements

• Bachelor’s degree in Software Engineering, Computer Science or equivalent with 8 to 10 years of managing delivery of advanced applications for mobile platform.
• Hands-on experience in mobile software development
• Android development experience (Kotlin or Java); familiarity with Kotlin Multiplatform (KMM) is a plus
• Understanding of mobile testing strategies and quality practices
• Experience working in Agile/Sprint-based development environments
• Ability to work at both technical detail and release-level view
• Experience creating and managing backlogs, tracking execution, and driving delivery
• Strong communication skills and ability to collaborate effectively across teams
• Strong attention to detail and an ability to deal with ambiguity

 

Nice to Have

• Good understanding of Continuous Integration environments (Jenkins, Bamboo, ElectricCloud)
• Experience with iOS platforms.
• Experience with configuration management tools and best practices (GIT, SVN, etc.).
• Ability to think strategically and execute methodically.
• Excellent written and oral communication skills. 
• Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
• Ability to influence cross-functional teams without formal authority.

]]> Thu, 09 Apr 2026 00:00:00 EDT 1
The marketing consultant is a key member of a product marketing team and will contribute to driving growth for the approved indication and/or preparing for entry into new disease areas. The marketing consultant will partner with the marketing team members and support the pull through of key print and digital tactics for HCPs and/or caregivers.

Responsibilities may include the following:
• Work closely with brand team members to develop and develop and roll out promotional materials (e.g., panels, leave behinds, rep triggered emails) to support branded and/or unbranded campaigns
• Partner with brand team members to provide operational support for key brand related activities including speaker programs, advisory boards, conferences and sales meetings
• Work with agency partners and guide the development of key marketing materials
• Partner with the team to develop and shape initiatives which could help generate brand demand
• Financial stewardship: Budgeting, managing the contracting, accrual and reconciliation process, etc.
• This position may require travel, such as attending various brand related events including key conferences, training events, and speaker events. The marketing team is based on on the San Rafael campus (hybrid); however, marketing consultants who wish to work remotely will be considered

Required skills and experience
• Pharma / biotech in-house marketing experience
• Project management experience
• Vendor / agency management experience
• Must be comfortable working in a fast-paced environment
• Demonstrated ability to optimize messages and claims in collaboration with the promotional review team (medical, regulatory, legal)

Preferred skills and experience
• Experience across multiple therapeutic areas; rare-disease experience a plus
• Prior pharma sales experience a plus


Education
• Bachelor's degree required
• Advanced degree (master's or higher) preferred

Required experience

4+ years experience in U.S. biotech / pharma marketing. Experience with the following programs and systems preferred: Veeva PromoMats, MS Word, Excel, Outlook, PowerPoint, Adobe Acrobat, MS Teams. Understanding of U.S. regulatory environment to support development of marketing materials and deliver key brand related initiatives.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.]]> Thu, 09 Apr 2026 00:00:00 EDT 1 This role applies advanced systems engineering principles to translate requirements into robust, compliant, and scalable solutions. The position operates with a high degree of autonomy, exercising sound engineering judgment to resolve complex technical challenges and ensure system performance in regulated, uptime critical environments.

DUTIES AND RESPONSIBILITIES:
• Lead the definition and interpretation of system requirements, operational scenarios, and success criteria for complex automation and biotechnology systems.
• Contribute to and influence system architecture and design concepts, applying engineering first principles to develop functional, elegant, and scalable solutions.
• Drive system integration activities across hardware, software, and controls, ensuring reliable interoperability and performance.
• Develop and execute verification and validation strategies, including functional testing, to confirm compliance with requirements, quality standards, and regulatory expectations.
• Create and apply analytical models to evaluate design alternatives, assess risk, and select robust technical solutions.
• Diagnose and resolve complex system failures, performing root cause analysis in environments where system uptime and reliability are critical.
• Produce and maintain system documentation, specifications, and technical reports to support development, testing, and lifecycle management.
• Ensure adherence to internal quality systems, industry standards, and applicable regulatory requirements throughout system development and deployment.
• Collaborate closely with cross functional partners (engineering, scientific, quality, and operations teams) to support successful project execution and system delivery.
• Provide technical guidance and knowledge sharing to peers and project teams as a subject matter contributor.

EDUCATION AND EXPERIENCE:
• Bachelor’s degree in Mechanical, Electrical, Computer, Biomedical, or Systems Engineering, or a related discipline.
• Minimum of 5 years of professional experience in systems engineering, automation, hardware development, or biotechnology related environments.

Target pay $75-80/hr based on experience ]]> Thu, 09 Apr 2026 00:00:00 EDT 0 Project Scheduler Electrical Infrastructure

Location
Fully on site five days per week

Contract Length
Twelve month contract with potential to extend

Start Timing
Targeting a start within two to three weeks

Engagement
Contract

Rate
Max pay rate on this 
Overview
Our Client is seeking an experienced Project Scheduler to support a large scale electrical infrastructure program. This role will focus on scheduling support for a major capital project portfolio and will work closely with a tight knit collaborative project team on site. The Project Scheduler will partner with an existing Project Manager and engineering stakeholders to plan maintain and optimize schedules across a high visibility electrical investment.
Key Responsibilities
The Project Scheduler will develop maintain and manage detailed project schedules for electrical infrastructure projects totaling approximately one hundred twenty seven million dollars. Responsibilities include supporting scheduling activities related to switchgear replacement and broader electrical infrastructure initiatives as well as partnering closely with the Project Manager and engineering teams to ensure schedules align with execution strategies. The role requires proactive identification of schedule risks constraints and dependencies with clear communication of impacts to stakeholders. The Scheduler will also provide scheduling support across additional engineering portfolios as project needs evolve while maintaining accurate up to date schedules and reporting tools.
Required Qualifications
Candidates must have a minimum of five years of experience in project scheduling project controls or a related role. An engineering background is preferred including mechanical electrical or general engineering. Strong hands on experience with Smartsheet is required. Candidates must be able to work fully on site five days per week and demonstrate excellent communication and interpersonal skills with a strong collaborative mindset. The ideal candidate is organized proactive and comfortable working within a close knit project team.
Additional Details
This position is not cGMP. It is a fully on site role and candidates must be within a reasonable commuting distance as long distance commutes may not be optimal for this engagement.
Why This Role
This is an opportunity to support a high impact capital intensive electrical infrastructure program with long term visibility and meaningful scope. The role offers the chance to work alongside an established Project Manager and experienced engineering team in an environment that values collaboration communication and team fit.
]]> Thu, 09 Apr 2026 00:00:00 EDT 0 Position Summary:
We are seeking a hands-on Director or Senior Director of Translational & Nonclinical Development with a “builder mindset” to lead nonclinical strategy and execution as we advance toward IND and clinical development.

This individual will lead a focused nonclinical safety (toxicology) and pharmacology strategy, working closely with experienced external partners and advisors on GLP toxicology and translational pharmacology studies to support first-in-human dosing and clinical development.

In parallel, this role will play a central role in advancing next-generation C7 program, including early-stage mechanistic studies, in vitro and in vivo model development, and evaluation of engineered variants designed to improve stability and efficacy.

This broad, high-ownership role is cross-functional and execution-oriented, requiring close coordination with CMC, regulatory, and external partners (CROs, academic collaborators).

---

Key Responsibilities:
• Nonclinical Strategy and IND-Enabling Development:

• Refine and execute a nonclinical strategy to support IND submission and early clinical development
• Design and oversee a focused set of GLP toxicology studies, supported by CRO’s and advisors, including:
  • 28-day repeat-dose systemic toxicity study
  • Local toxicity evaluation in disease-relevant wound model
• Leverage external toxicology expertise to ensure study alignment with regulatory expectations and Pre-IND feedback
• Refine dose strategy for first-in-human studies

• Pharmacology & Translational Development

• Lead design and execution of follow-up pharmacology studies to demonstrate biological activity and dose-response
• Integrate internal and external data to inform dosing strategy and trial design
• Support development of biomarkers and in vivo assays to evaluate drug activity and durability
• Lead preparation of nonclinical sections of regulatory submissions (IND)

• Next-Generation C7 Program Leadership

• Lead early-stage development of degradation-resistant next-gen C7 variants
• Oversee studies to:
  • Characterize C7 degradation
  • Identify sites and mechanisms
  • Evaluate engineered variants for improved stability and retained function
  • Guide development of in silico, in vitro and in vivo screening systems for variant prioritization
• Coordinate external partners (CROs, protein engineering groups) and internal efforts to advance program milestones

• External Partner & Study Management

• Select and manage CROs and academic collaborators executing toxicology, pharmacology, and translational studies
• Ensure studies are executed with high quality, rigor, and on timeline
• Provide hands-on scientific direction and maintain efficient execution

• Cross-Functional Leadership

• Partner closely with:
  • CMC on material selection and study readiness
  • Regulatory on strategy and agency interactions
  • Leadership / investors on program updates and key decisions
• Contribute to integrated development plans, including timeline, budget, and risk management
• Support broader company strategy across lead and next-gen programs

---

Qualifications:

• Advanced degree in pharmacology, toxicology, biomedical sciences, or related field
• ~10+ years of experience in nonclinical development, ideally with biologics or protein therapeutics
• Direct experience overseeing GLP toxicology studies and IND-enabling packages
• Strong understanding of regulatory expectations for biologics
• Experience with translational pharmacology and disease-relevant models
• Demonstrated ability to manage external partners (CROs, academic groups)
• Experience working in small, fast-paced biotech environments preferred
• Ability to communicate and work effectively with cross-functional teams and valued advisors

---

What We Offer:

• Opportunity to lead nonclinical and translational strategy at a formative stage company
• High ownership across both lead clinical program and next-generation pipeline
• Significant growth potential as the company advances into clinical development
• Competitive salary, equity, and benefits

]]> Thu, 09 Apr 2026 00:00:00 EDT 0 Support manufacturing operations by improving process efficiency, maintaining stable production, and ensuring high-quality output. Troubleshoot issues, conduct trials, and coordinate technology transfer and validation activities for new and existing products.
Key Responsibilities
Manufacturing Process Control & Documentation

• 
  Develop, maintain, and revise manufacturing specifications, product history documents, SOPs, and regulatory-related documentation.
  
• 
  Participate in project teams for process improvements and technology implementations.
  
• 
  Prepare annual process review reports and maintain records for compliance purposes.
  

Process Optimization & Trials

• 
  Design and conduct experiments and pilot-scale trials to improve manufacturing efficiency.
  
• 
  Summarize findings and implement improvements in formulation processes.
  
• 
  Stay updated on industry and formulation technologies and share insights with the team.
  

Problem Solving & Validation

• 
  Troubleshoot production issues from a pharmaceutical perspective.
  
• 
  Plan and execute validation and trial activities, including drafting plans, conducting tests, and reporting results.
  
• 
  Acquire knowledge and maintain operational expertise for formulation equipment.
  

Technology Transfer & Cross-Site Coordination

• 
  Plan and implement manufacturing technology transfers for new products or between sites.
  
• 
  Coordinate with relevant departments to ensure smooth transitions.
  
• 
  Execute associated validation plans and document outcomes.
  

Continuous Improvement & EHS

• 
  Identify and implement process improvements to enhance efficiency and product quality.
  
• 
  Promote multi-skill development to balance workloads effectively.
  
• 
  Implement workplace safety, health, and environmental initiatives, including 5S activities.
  

Qualifications & Experience

• 
  University graduate in Pharmacy, Chemistry, or a related scientific field.
  
• 
  Practical experience in pharmaceutical manufacturing processes, including technology transfer for solid dosage forms.
  
• 
  Strong knowledge of GMP, pharmaceutical production principles, and regulatory requirements.
  
• 
  Ability to work independently, adapt to changing priorities, and take initiative to deliver results.
  

Skills & Attributes

• 
  Analytical and problem-solving mindset
  
• 
  Effective communication and teamwork
  
• 
  Strong organizational and documentation skills
  
• 
  Commitment to quality, safety, and operational excellence
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 As a Project Manager, INDIGO, you will support in advancing a comprehensive AI strategy through our INDIGO program, an enterprise-wide initiative to expand the impact of machine learning and AI capabilities across our business. Your role will involve leading cross-functional projects supporting the Foundational AI workstream within INDIGO and partnering closely with the INDIGO Program Manager to further establish the team’s agile transformation. By aligning outcomes and processes with strategic goals and ensuring that projects are delivered on time and in budget, you will be pivotal in contributing to best practices, shaping INDIGO operations, and ensuring successful outcomes on investments in ML and AI technologies and products.

Competitive candidates must demonstrate strengths in collaboration, organization, problem solving, facilitation, communication, and thrive in a fast paced environment. They bring deep experience in agile project management, and AI applications within the pharmaceutical or life-sciences industry, along with a solid conceptual background in artificial intelligence and information technology. The candidate must be an experienced and certified Project Manager in AI and IT initiatives using SCRUM and Agile methodologies. This role is based in our Waltham location and follows a hybrid office schedule.

Key Responsibilities
• Define and Clarify Objectives: Establish clear project objectives, scope, and success criteria, aligning both Agile and traditional planning approaches,
• Develop Project Plans: Build and maintain hybrid project plans that combine iterative delivery (sprints, backlogs, increments) with structured timelines, milestones, and resource planning and budget alignment to ensure projects are delivered on scope, on time, and within financial targets.
• Resource Management and Capacity Management: Coordinate team capacity, skills, and resource needs across workstreams to ensure smooth execution.
• Team Leadership: guide the project team by facilitating Agile ceremonies, coordinating cross-functional workflows, assigning responsibilities, and monitoring progress toward deliverables.
• Proactive risk and issue management, identify risks early, drive mitigation strategies, resolve issues quickly, and ensure strong cross-functional communication and alignment.
• Maintain project artifacts and communication tools, develop and manage key project documents, dashboards, and communication mechanisms that support transparency and collaboration across teams.
• Support portfolio governance, contribute to portfolio level governance by applying structured frameworks, consistent reporting, and disciplined execution across hybrid delivery models.
• Foster a collaborative team environment that cultivates and promotes: a “learning” team mindset which seeks, assesses & incorporates feedback-learnings-new/evolved ideas, open and transparent communication, and constructive conflict resolution.
• Training and Support: Organize and facilitate training for users of implemented AI solutions.
• Post-Project Evaluation: Conduct evaluations to assess project success and identify areas for improvement.


Core Competencies
• Experience: Proven experience in managing AI and technology projects, with a strong emphasis on Agile methodologies.
• Skills: Strong ability to lead complex projects from initiation to delivery, including planning, budgeting, risk management, and cross functional collaboration using hybrid methodologies; excellent communication and leadership.
• Strong change management awareness with the ability to guide teams through evolving AI governance requirements.


Preferred Qualifications
• Demonstrated ability to manage global complex, cross-functional technology projects with a solid understanding of software development lifecycles, system architecture, and integration principles to effectively communicate with technical teams to ensure delivery of scalable solutions.
• Forward thinking mindset with a passion for leveraging AI to drive business value.
• Skill in translating governance policies into actionable workflows for technical and scientific teams.
• Flexibility to adapt to changing project requirements and environments.
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Can you please confirm your top 3 skills sets required?

1. 1. Hardware Engineering: Strong foundation in electrical hardware design, hardware characterization, bench testing, troubleshooting, and debug
   2. AI Tool Development and Utilization: Ability to develop, adapt, and apply AI-enabled tools to improve engineering design, development, analysis, and test workflows.
   3. PCB Design and Circuit Modeling: Experience with PCB design, schematic capture, circuit simulation, and modeling to support robust hardware development.
   4. Formal test planning, execution, and documentation in medical device or similarly regulated industry

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

1. 1. Execute hardware test, characterization, and debug activities to support electrical design development, integration, and issue resolution.
   2. Develop and drive formal characterization and verification efforts, including test planning, execution, data analysis, and documentation.
   3. Implement and apply AI-enabled tools and workflows to accelerate engineering design, development, test, analysis, and documentation activities.
   4. Experience with AI in hardware development such as embedded intelligence, edge AI, or AI-enabled hardware systems is a strong plus.

What products (if any) will this role support?  Cardiac implantable devices such as implantable monitors, pacemakers, and/or implantable defibrillators

What is your target years of experience?  3+ years of relevant experience in electrical hardware engineering, including design, characterization, testing, debug, and integration.  1+ years of experience applying automation, scripting, AI tools, or AI-enabled workflows to engineering development, analysis, or test activities is preferred.

When do you plan to start interviewing?  April

Will you be looking to hire and start ASAP or will the start date be delayed?  ASAP

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  Onsite
__________________________________________________________________________________________________________________________

Responsibilities may include the following and other duties may be assigned.
Researches, develops, designs, integrates, and tests electrical components, equipment, systems, and networks for medical devices and related platforms. Designs electrical hardware, assemblies, PCBAs, power architectures, sensing and acquisition circuits, embedded hardware, and system-level electrical interfaces for regulated products. Applies strong systems engineering discipline across requirements development, architecture, design, risk management, integration, verification, validation, and design transfer. Leverages AI-enabled engineering tools to improve engineering productivity, quality, and decision-making in areas such as requirements analysis, documentation generation, data analysis, test development, failure investigation, and workflow automation. Uses practical experience with AI/ML concepts to support electrical and hardware development, including edge or embedded AI, real-time inference considerations, model optimization for constrained compute, and hardware/software co-design. Creates and improves automated methods for engineering tasks related to functional expertise, including test automation, data reduction, reporting, and design process efficiency. Partners cross-functionally with systems, software, mechanical, quality, manufacturing, regulatory, and supplier teams to deliver robust, compliant, and scalable solutions. This is a contract position supporting the Electrical Systems Design Group.

SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty spanning electrical systems design, electrical hardware development, and AI-enabled engineering methods for medical devices. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or direct the work of lower-level professionals. The majority of time is spent delivering and overseeing projects from design through implementation while adhering to policies, quality system requirements, and specialized knowledge and skills normally acquired through advanced education and relevant industry experience.

DIFFERENTIATING FACTORS

Autonomy:
Recognized technical specialist, managing medium to large projects or processes. Exercises considerable latitude in determining deliverables, methods, tools, and technical approaches, with limited oversight from manager. Makes sound engineering decisions across electrical architecture, hardware design, integration, verification, and use of AI tools for engineering workflows. Coaches, reviews, and delegates work to lower-level specialists when appropriate.

Organizational Impact:
Contributes to defining the direction for new products, processes, technical standards, and operational plans based on business strategy, with significant impact on work group results. Helps shape how AI-enabled tools and automation are adopted within the Electrical Systems Design Group to improve speed, consistency, traceability, and design quality. May manage large projects or processes that span outside the immediate job area.

Innovation and Complexity:
Problems and issues faced are difficult, moderately complex, and often undefined, requiring detailed information gathering, analysis, and investigation. Develops solutions to moderately complex problems and/or makes moderate to significant improvements to processes, systems, or products independently to enhance performance of the job area. Applies engineering judgment to balance safety, reliability, performance, manufacturability, compliance, and schedule. Evaluates and implements practical AI/ML approaches for engineering and hardware use cases, including workflow automation, analysis of large datasets, model-assisted engineering, and deployment considerations such as latency, local compute limits, quantization, distillation, model size, and real-time behavior.

Communication and Influence:
Represents the organization as a primary contact for specific projects and initiatives; communicates with internal and external customers, suppliers, and vendors at various levels. Communicates complex electrical systems, hardware, and AI-related concepts clearly and effectively to technical and non-technical stakeholders. May negotiate with others to reach understanding or agreement, and influence decision-making related to architecture, risk, verification strategy, supplier engagement, and engineering tool adoption.

Leadership and Talent Management:
Typically provides guidance, coaching, and training to other team members within the job area. Typically leads major or moderately complex projects involving delegation of work and review of work products, at times acting as a technical team leader. In a contract capacity, is expected to provide strong technical leadership, elevate team capability, and share best practices in electrical systems development, AI tool utilization, and engineering automation.

Required Knowledge and Experience:
Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. Must have strong experience in electrical hardware and electrical systems development for medical devices, including system architecture, analog and digital design, power and signal integrity, embedded hardware, integration, bench testing, and root-cause analysis. Must have practical experience using AI tools to improve engineering output and automating functionally relevant workflows through scripting, data analysis, test automation, requirements support, documentation generation, or similar applications. Experience with AI/ML for hardware-related use cases is strongly preferred, including edge or embedded AI, real-time inference on constrained hardware, model optimization, quantization, distillation, hardware/software co-design, and evaluation of AI performance in production-like environments. Working knowledge of design controls, risk management, verification and validation, and regulated product development is required; familiarity with standards and frameworks such as IEC 60601, ISO 13485, and FDA-regulated development environments is preferred. May have broad knowledge of project management. Requires a University Degree and minimum 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Key Responsibilities
Fixed Asset Accounting & Reporting
• Manage end to end fixed asset accounting, including additions, disposals, transfers, impairments, and depreciation
• Maintain the fixed asset subledger and ensure alignment with the general ledger
• Perform monthly close activities: journal entries, reconciliations, roll forwards, and variance analysis
• Review and validate asset classifications in accordance with US GAAP and company policy
• Support internal and external audit requests related to fixed assets

CAPEX Accounting & Project Support
• Partner with project managers to monitor capital project spend and ensure proper capitalization vs. expense treatment
• Asset Under Construction (AUC) balances and drive timely project closures
• Assist in forecasting depreciation and CAPEX impacts for FP&A and business partners
• Ensure compliance with capitalization policies and support continuous process improvements

OPEX PO & Accrual Analysis

• Perform monthly OPEX purchase order (PO) reviews to ensure accuracy of commitments, proper coding, and alignment with budget expectations
• Prepare and analyze OPEX accruals, ensuring completeness and accuracy of period end expense recognition
• Partner with budget owners to investigate and explain OPEX variances, providing clear insights into drivers and trends
• Monitor open POs and goods/services receipts to validate timing of expense recognition and identify items requiring cleanup or closure
• Support monthly OPEX reporting packages, including variance commentary and analysis for FP&A and business partners
• Strengthen OPEX-related controls and contribute to process improvements that enhance transparency, accuracy, and efficiency in operating expense management

Controls, Compliance & Process Improvement
• Maintain strong internal controls over fixed asset and CAPEX processes
• Support SOX documentation, testing, and remediation activities
• Identify opportunities to streamline workflows, enhance reporting, and improve data integrity
• Contribute to system enhancements or ERP projects impacting fixed asset accounting
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Qualifications
Required
• Bachelor’s degree in accounting, Finance, or related field
• 5+ years of relevant accounting experience, including 3+ years focused on fixed assets and/or CAPEX
• Strong understanding of US GAAP, including capitalization rules and depreciation methodologies
• Advanced Excel skills and experience working with large data sets
• Experience with major ERP systems (SAP, Oracle, NetSuite, or similar)

Preferred
• CPA or CPA eligible
• Experience in biotech, pharma, manufacturing, or other capital-intensive industries
• Familiarity with SOX controls and audit processes
• Experience with project accounting modules or fixed asset subledger systems

Key Competencies
• Strong analytical and problem-solving skills
• High attention to detail and accuracy
• Ability to manage multiple priorities and meet deadlines]]> Thu, 09 Apr 2026 00:00:00 EDT 1
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at Thousand Oaks and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of products. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Responsibilities include, but are not limited to, the following:
• Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
• Assist in the design and execution of experiments in order to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
• Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments
• Support development and maintenance of technology transfer tools (clinical and commercial)
• Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
• Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
• Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
• Development of digital tools and models by leveraging data analytics and programming skills
• Support at scale characterization and/or process validation runs as person in plant
Preferred Qualifications:
• B.S. in scientific or engineering discipline with 1?3 years’ experience or M.S. in scientific or engineering discipline with 0?2 years’ experience
• Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
• Knowledge of and hands-on experience with various drug product technologies
• Displayed critical thinking, problem solving and independent research skills
• Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
• Excellent project management skills and ability to escalate relevant issues to project lead and line-management
• Strong cross functional team player with good communication skills (oral and written)
• Ability to work independently and as part of a team with internal and external partners
• Good computer and organizational skills with strong attention to detail
• Self-motivated with a positive attitude]]> Thu, 09 Apr 2026 00:00:00 EDT 1 23 months
competitive bid, send candidates according to experience
Danvers MA
HM Jeffrey Witts
1 opening, 3 slots

Per HM, candidates need to have knowledge of RJG Co-pilot system and setting up DC2 and DC3 processes or they will get rejected as this is required for the role

Top 3 technical  skills that are required for the role:

1. Injection Molding Process development
2.  Scientific Molding Principles
3.  Knowledge of RJG Cavity Pressure systems 

Education Required: BS In Plastics Engineering or equivalent

Years’ Experience Required: Minimum of 7 Years Experience Required


Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects and processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Are you a visionary biostatistician with a passion for driving groundbreaking therapies? We are seeking two exceptional Lead Biostatisticians to lead statistical strategies across major indications within a dynamic, innovative biotech or pharmaceutical environment. If you thrive in a leadership role, excel in complex study design, and possess a bold approach to data, this is your chance to influence life-changing treatments and elevate your career to new heights.

What You Will Do:
As a Lead Biostatistician, you will serve as the indication expert, guiding all statistical activities across multiple assets and driving innovative approaches from early development through submission. You will develop and execute data strategies, oversee key deliverables, and collaborate closely with cross-functional teams—ensuring successful clinical program outcomes. Your leadership will influence health authority submissions and contribute to global approvals, shaping the future of patient care. 

Essential Skills & Qualifications:

• Deep expertise in biostatistics with a proven track record of leading complex clinical programs (Phase I-IV) and submissions, including BLA/NDA/MAA dossiers
• Exceptional communication skills with experience presenting to senior leadership and external stakeholders
• Extensive experience in study design, protocol development, and technical leadership
• Strong background in collaborative, cross-disciplinary teams and strategic decision-making
• Proficiency in SAS, R, and CDISC standards; Bayesian methods considered a plus
• Experience with rare diseases, orphan indications or autoimmune conditions is desirable.
• Demonstrated ability to innovate and think strategically at a game-changing level, especially in combination trials with dual mechanisms of action

Nice to Have Skills:

• Experience with complex adaptive designs or cutting-edge statistical methods
• Fluency in additional languages beyond English
• Prior experience in global regulatory interactions and submissions at late stages of development

Preferred Education & Experience:

• Master’s or Ph.D. in Statistics or a related quantitative field
• Minimum 7 years of industry experience in biotech or pharma, with significant leadership responsibilities and hands-on study design expertise
• Proven record of guiding studies through to global regulatory approvals in a high-stakes environment

Take this opportunity to lead pioneering studies, influence major clinical decisions, and drive innovations that matter. If you are a strategic thinker, a hands-on statistician, and a visionary leader ready to make a difference, we want to hear from you. Apply now to become a key player in transforming patient lives through cutting-edge biostatistics!

If you are interested in this position but don't fully match all the requirements, please do still apply to discuss your career, other opportunities with this or any of our other clients. The team at Planet Pharma will be very happy to discuss options with you and help you get to where you want to be in your career. 
]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Target Pay Rate: 45-57/hr **salary will be commensurate with experience 

Description:
Primary responsibilities of this role include the following:
Ensure efficiency and completeness in prescription processing and dispensing. Oversight of all record keeping and licensing to guarantee accuracy and compliance with state and federal pharmacy regulations. Review, update and adhere to pharmacy protocols and procedures to maintain compliance with all applicable regulatory agency regulations. Report prescription audit results and trending on monthly basis. Communication of issues with appropriate personnel including other Pharmacists from remote locations and Customer Service personnel. Communication with Customer Service personnel to perform/verify order entry quantities from customer data system. Ensures all required documentation is maintained, including exception reporting. Assures compliance with standard operating procedures (SOPs), quality assurance and JCAHO standards, local state and federal regulations, and good manufacturing practices (GMPs), if applicable. Other duties related to Pharmacy as assigned.

Job Requirements:
B.S. or PharmD from accredited School of Pharmacy and hold an active Utah pharmacist license. Candidates must have excellent interpersonal and organizational skills.]]> Thu, 09 Apr 2026 00:00:00 EDT 1 A leading organisation in medical technology is seeking a Coronary Sales Representative to support the expansion of its interventional cardiology portfolio across Spain. This position focuses on building strong clinical and commercial partnerships with cardiac centres while driving sustainable therapy growth.
About the Role
You will shape and deliver a territory strategy that strengthens relationships with interventional cardiologists cath lab teams procurement groups and hospital leaders. Working closely with clinical colleagues you will support therapy adoption ensure high quality product knowledge and deliver exceptional service across all accounts.
Key Responsibilities
• Drive commercial growth across the coronary portfolio by engaging hospitals and clinical teams throughout the region
• Build trusted relationships with interventional cardiology stakeholders and position the organisation as a valued partner
• Collaborate with clinical specialists to support case activity education sessions and training programmes
• Identify and develop new business opportunities and contribute to territory planning and therapy expansion
• Provide accurate information on products and ensure all work complies with ethical regulatory and quality standards
• Monitor market trends and communicate customer insights to support wider commercial strategy
Required Experience
• Strong background in coronary or interventional cardiology sales within the medical technology sector
• Proven track record of growing commercial accounts and influencing both clinical and procurement decision makers
• Good understanding of cath lab workflow and interventional procedures
• Excellent communication relationship building and negotiation skills
• Willingness to travel across the assigned region in Spain
Education
• Degree in life sciences business or another relevant field
]]> Thu, 09 Apr 2026 00:00:00 EDT 1
The Role
A leading medical technology organisation is seeking a Clinical Specialist to support its structural heart and interventional cardiology therapies across Switzerland. You will act as the clinical authority in TAVI and coronary interventions, providing expert case support, strengthening clinical practice, and driving therapy adoption within key cardiac centres.
Key Responsibilities

• Deliver in?lab case support for TAVI and coronary procedures across Swiss hospitals.
• Provide high?quality clinical training and ongoing education to physicians, cath lab teams and wider MDT groups.
• Act as the clinical partner to the commercial team, contributing to therapy growth and improved procedural pathways.
• Support new site activation, proctoring schedules, and competency development across accounts.
• Maintain strong knowledge of clinical data, procedural guidelines and evolving best practices.
• Feed insights into territory planning, identifying opportunities to enhance therapy utilisation and outcomes.

Required Experience

• Extensive experience supporting TAVI and/or coronary interventions within a hospital or med?tech setting.
• Strong background providing in?procedure support in cath labs or structural heart environments.
• Excellent communication skills with the ability to influence and educate senior clinicians.
• Demonstrated success working with interventional cardiology teams in complex procedures.
• Willingness to travel nationally across Switzerland.

Education

• Degree in a relevant clinical discipline such as nursing, cardiac physiology, radiography, or biomedical science.

]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Target Pay Rate: 40-50/hr **salary will be commensurate with experience 

Summary
The Environmental Health and Safety (EHS) Manager is responsible for leading and managing EHS programs for the Largo, FL Depot and UCAN Field Service Teams. This role provides strategic direction, ensures compliance with regulatory and corporate standards, and drives initiatives that reduce risk and
promote a culture of safety and environmental stewardship. The EHS Manager partners with cross-functional teams to implement best practices, deliver continuous improvement, and align operations with organizational goals.

The Essential Roles and Responsibilities
Leadership & Strategy
• Develop and execute EHS strategies that align with corporate objectives and regulatory requirements.
• Foster a proactive safety culture through leadership engagement, employee training, and continuous improvement initiatives.
• Implement proactive incident prevention initiatives and lead corrective actions to reduce future risk.
• Manage EHS-related projects from planning through execution, ensuring timely delivery and alignment with organizational priorities.
Compliance & Risk Management
• Ensure adherence to all applicable EHS laws, regulations, and policies across Depot and Field operations.
• Conduct risk assessments, inspections, and audits; implement timely corrective actions to mitigate hazards.
• Serve as the primary liaison with regulatory agencies (EPA, OSHA) for inspections, permitting, and reporting.
Program Development & Implementation
• Lead the creation and maintenance of EHS standards, procedures, and content within the Quality Management System.
• Oversee emergency preparedness and response programs, including hurricane planning and execution.
• Administer Fire Captain and First Responder programs and ensure compliance with hazardous materials shipping regulations.
Employee Engagement & Training
• Organize and manage employee safety programs (PPE distribution, blood drives, recognition events).
• Partner with UCAN Field Service Managers to reduce mobile workforce incidents and improve safety awareness.
Incident Management & Reporting
• Lead workplace injury investigations and collaborate with leadership on corrective actions.
• Manage Workers’ Compensation cases, including restricted duty and return-to-work programs.
• Collect and maintain accurate EHS data in the corporate database.
General Compliance
• Comply with all environmental, health, and safety requirements, including department-specific standards.

Required Qualifications
• Proven track record of interpersonal skills with ability to interface well with others and integrate into other team environments.
• Experience prioritizing and managing multiple and technically complex assignments concurrently.
• Organized, analytical, detail-oriented, problem-solver, project management skills and focus on results.
• Experience in influencing cross-functional teams in a fast-paced and diverse environment.
• Proven ability to deliver individual and team results.
• Ability to analyze and interpret scientific, statistical data and information to determine potential root cause and paths for process improvement.
• Strong professional writing skills and ability to prepare technical reports.
• Ability to clearly articulate information during regulatory inspections.
• Ability to understand applicable regulatory guidelines.
• Strong assessment and troubleshooting skills.
• Ability to respond to detailed inquiries and present information to groups and leaders.
• Computer proficiency in Microsoft Office and ability to use enterprise software.
• Demonstrated critical thinking and problem-solving skills.
• Possess a working knowledge of related disciplines/other functions including technical services and operations processes.
• Subject matter expert in applicable EHS&S regulations

Experience and Education
• B.S. Degree in Environmental, Safety, Engineering or related field required.
• Minimum of 5 years of EHS experience working in manufacturing, servicing of medical devices, pharmaceuticals, or biotechnology.
• Must be conversant in applicable EHS regulations.
• Professional certifications preferred]]> Thu, 09 Apr 2026 00:00:00 EDT 1 *depending on experience

Position Overview
Associate Scientist II is primarily responsible for testing samples, drafting methods and reporting data under cGMP regulatory guidance for Large Molecules/Biologics product development and related stability studies.

In support of Large Molecules/Biologics Therapeutics, will execute laboratory testing using the following techniques as required:
• Mammalian cell culture
• Sterile technique
• In vitro cell based assays (e.g., reporter gene bioassay, cell titer glo proliferation bioassay, etc.)
• ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD)
• Molecular biology (e.g., qPCR, PCR, etc.)
• Kinetic binding assessment (e.g., BLI or SPR)
• Flow cytometry
• Other technologies/methodologies as required by management

II. Essential Functions
• Reads and follows Standard Operating procedures with attention to details
• Successfully trains on 1-2 methods and/or techniques mentioned above and performs adhoc sample testing activities under cGMP as required
• Applies basic scientific and laboratory concepts and theories related to specific testing in the group
• Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance. Supports drafting of simple methods, method forms and result reports.
• Adheres to policies, processes, and procedures for operating laboratory equipment in a safe and compliant manner
• Understands the Catalent culture, programs, and communication processes regarding quality, safety, and ethical practices
• All other duties as assigned

III. Position Requirements
Education and Experience:
• Bachelor’s Degree in Life Sciences or Physical Science field. No work experience required

Knowledge/Skills Requirements:
• Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry, Biochemistry).
• Excellent written and verbal communications skills with internal customers, colleagues, and supervisor
• Well organized with ability to multitask and be flexible with daily work schedule
• Ability to work effectively under pressure to meet deadlines
• Ability to pay attention to detail and exhibit critical thinking]]> Thu, 09 Apr 2026 00:00:00 EDT 1
Job Description:
• Responsible for maintenance and repair of all building support equipment/systems including HVAC, boilers, electrical, emergency power and plumbing in a FDA regulated industry.
• Responsible for preventative maintenance and repair of laboratory equipment including autoclaves, RO/DI water system, incubators, temperature/humidity chambers, refrigerators, freezers, exhaust fans, clean rooms, laminar airflow hoods, and biological safety cabinets.
• Completes/troubleshoots unscheduled repairs of building and laboratory equipment
• Coordinates contractors and ensures completion of all tasks
• Picks up parts and supplies at local vendors.
• Assists in all phases of assigned project work including planning, scheduling, acquiring materials, and scheduling contractors. Completes project within budget and on time.
• Responds to emergency calls after scheduled working hours, weekends, and holidays.
• Assists in training.

Qualifications & Technical Competencies:
*Experience in an industry GxP setting strongly preferred 
•    High school diploma or GED required.  Associate’s degree and/or equivalent industry/trade training (e.g. apprenticeship program) preferred.
•    Minimum 5 - 7 years of related maintenance experience required
•    Knowledge of Siemens Building Automation System and Square D Lighting System.
•    Working knowledge of building renovation including framing, drywall, wiring, building codes, computer/phone cabling, T-Bar suspension ceiling and painting.
 ]]> Thu, 09 Apr 2026 00:00:00 EDT 0 A global med?tech organisation is entering the orthopaedics space across ANZ and is searching for a hands?on commercial leader to establish its presence in New Zealand. Based in Auckland, this role offers the rare opportunity to launch a portfolio, shape the commercial footprint, and build the operation from the ground up.

---

The Role
This is a field?based position focused on Hip and Knee reconstruction. You’ll oversee territory sales, surgeon engagement, distribution partnerships, operational execution and market intelligence — essentially owning the entire commercial function for NZ.

It’s well?suited to someone entrepreneurial, commercially driven and excited by building a business in a developing market.

---

What You’ll Do Sales & Market Ownership

• Manage all territory activity for Hip & Knee implant solutions.
• Build relationships with surgeons, hospitals and theatre staff across the Auckland region and beyond.
• Support cases, provide product education and ensure strong clinical engagement.
• Lead revenue growth in line with annual expectations.

Business Management

• Coordinate with hospital finance and admin teams to support payment cycles.
• Align pricing and commercial decisions with regional leadership.
• Establish distribution terms that reflect volume needs and business objectives.
• Develop understanding of hospital procurement structures and reimbursement pathways.
• Travel within and outside NZ as required.

Distributor Development

• Identify and onboard distributors, sub?distributors and agents.
• Strengthen partner capabilities through regular communication, training and operational support.
• Monitor inventory levels and ensure smooth delivery of products through the network.

Hospital Engagement & Relationship Building

• Meet with surgeons and procurement teams to share clinical insights and support purchasing discussions.
• Present clinical evidence, educational material and technical demonstrations.
• Participate in long?term planning with hospitals and buying groups.

Market Intelligence

• Map the competitive landscape and capture real?time market information.
• Maintain structured data on surgeon profiles, procedure volumes, pricing dynamics and hospital behaviours.
• Monitor upcoming tenders and shifts in purchasing policies.

Compliance & Governance

• Conduct all activities ethically and in line with organisational standards.
• Ensure engagement with clinicians and hospitals follows local regulations.
• Provide required updates or documentation to hospital stakeholders as needed.

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  Who You Are

• At least three years of experience in Hip & Knee reconstruction (specifically implants).
• Recent and active involvement with orthopaedic theatres.
• Strong commercial instincts and comfort operating independently.
• Experience building territories, partnering with distributors and working closely with surgeons.
• Highly organised and adaptable, with a proactive mindset.

]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Role: Process Lead (Senior level)
Employment Type: Full-Time or Contract
Location: Japan
Candidate Requirements:

• Must already be based in Japan
• English: Required
• Japanese: Not mandatory (nice to have)

Profile Overview
Senior Process Lead and Subject Matter Expert with extensive experience supporting greenfield pharmaceutical manufacturing facility projects, with particular expertise in Oral Solid Dosage (OSD) production environments.

Experienced in leading process design, equipment strategy, vendor oversight, and full project lifecycle support from early engineering phases through commissioning and start-up. Strong background in GMP compliance, process optimisation, and cross-functional collaboration within complex, large-scale capital projects.

Core Responsibilities
Process Design & Technical Advisory

• Acted as OSD Process SME across all project phases
• Defined and reviewed OSD process concepts including granulation, blending, compression, coating, and encapsulation
• Supported decision-making regarding process technology selection (batch vs continuous)
• Developed and reviewed Process Flow Diagrams (PFDs), material and mass balances, and detailed process descriptions
• Provided expert input on QbD frameworks, identification of CQAs and CPPs, and conducted process risk assessments

Equipment Strategy & Vendor Management

• Defined process equipment philosophy for OSD manufacturing
• Developed, reviewed, and challenged User Requirement Specifications (URS)
• Led technical evaluations of vendors, bid comparisons, and equipment selection processes
• Participated in FAT and SAT activities, providing technical oversight on behalf of the client
• Reviewed mechanical and process data sheets and vendor documentation
• Ensured compliance with specifications through vendor drawing review and inspection oversight

Greenfield Project Leadership

• Supported project delivery through basic design, detailed design, commissioning, qualification, and start-up phases
• Interfaced with engineering, automation, QA, validation, and EPCM partners
• Reviewed project deliverables to ensure GMP compliance and preservation of process intent

Engineering Oversight & Governance

• Monitored and reviewed technical deliverables from FEED/FEL and EPC contractors
• Verified alignment with engineering standards, project design bases, and process/utility requirements
• Reviewed engineering documents including PFDs, P&IDs, plot plans, hazardous area classifications, electrical diagrams, and building layouts
• Participated in HAZOPs, safety reviews, and model reviews
• Assessed contractor deviation requests and resolved specification conflicts
• Reviewed change claims and ensured technical validity

Utilities, Infrastructure & Environmental Compliance

• Reviewed utility balances and validated capacity against project requirements
• Assessed effluent material balances and treatment capacity
• Ensured compliance with environmental standards and regulatory requirements
• Supported optimisation of infrastructure, offsites, and utilities

Quality, Safety & Compliance

• Ensured adherence to GMP, quality standards, and project documentation requirements
• Reviewed engineering strategies, work processes, and standardisation approaches
• Supported safety, health, and environmental compliance
• Monitored development of operating philosophies including plant start-up and shutdown sequences
• Ensured engineering document handover aligned with EDMS requirements

Value Engineering & Optimisation

• Identified cost-saving and process optimisation opportunities
• Contributed to value engineering initiatives
• Supported development of integrated operating plans

]]> Thu, 09 Apr 2026 00:00:00 EDT 1

We are supporting a medical devices organisation seeking a Clinical Sales Specialist to join its structural heart and interventional cardiology team. This role focuses on TAVI and coronary solutions and supports cardiologists, cath lab teams, and wider clinical stakeholders across the Christchurch region.
The Opportunity
You will provide high quality clinical case support in the cath lab, build strong relationships with physicians, and help drive adoption of market leading cardiovascular technologies. You will collaborate closely with the sales team, deliver product expertise, and contribute to regional growth while ensuring outstanding patient centric support.

---

What You Will Do Cath Lab and Clinical Case Support
• Provide in procedure support for TAVI and coronary interventions
• Ensure clinicians and cath lab teams have the technical and procedural guidance required for safe and effective product use
• Deliver product demonstrations, training, and education on device preparation, deployment, and best practice
Customer Engagement and Education
• Build strong relationships with interventional cardiologists, nurses, and allied health professionals
• Organise and support workshops, in service training, and regional education events
• Be the clinical expert for the territory, offering clear guidance across TAVI and coronary portfolios
Commercial Partnership
• Partner with the sales team to support account growth and product adoption
• Identify opportunities to increase utilisation through education, clinical expertise, and customer engagement
• Maintain expert knowledge of the competitive landscape and emerging clinical practices
Territory Support
• Provide ongoing clinical presence across Christchurch and surrounding areas
• Ensure exceptional pre procedure and post procedure support for all customers

---

About You
• Clinical background in cardiology cath lab nursing physiology or related field
• Experience supporting TAVI and or coronary intervention is strongly preferred
• Strong relationship builder who communicates clearly and confidently in high pressure clinical settings
• Comfortable working in procedures with a calm and supportive manner
• Proactive organised and committed to delivering excellent patient focused outcomes
• Able to collaborate with both clinical and commercial teams
]]> Wed, 08 Apr 2026 00:00:00 EDT 1
Maintenance Mechanic 4 - US1

Summary
This position maintains and repairs the facility's structure, equipment and ground, including plumbing, electrical and HVAC.

Key Responsibilities
- Responsible for a variety of mechanical service calls and in-house repairs throughout the facility and grounds.
- Acts independently to determine methods and procedures on new assignments.
- Provides guidance and oversees other maintenance personnel.
- Performs skilled trade work, such as carpentry or painting in the construction, repair or alteration of structures such as walls, roofs, or office fixtures.
- Monitor, maintain, document, and perform preventive maintenance on HVAC system including Central Plant.
- May work from sketches, blueprints, and drawings.
- Act as liaison and supervise work of contractors.
- Be on call and able to respond 7/24/365

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position.
Changes to individual responsibilities may occur due to business needs.

Qualifications
Minimum Requirements
-High School Diploma/ GED required.
-Reliabe transportation required, on-site M-F 8-5
-Boulder location.]]> Wed, 08 Apr 2026 00:00:00 EDT 1
Position Summary:
We are seeking a highly motivated and experienced Associate in Quality Control (QC) Chemistry to support the startup and operational readiness of our QC laboratory. Working with minimal supervision, this individual will lead and contribute to critical activities including system qualifications, method transfers, and laboratory operations in a GMP-regulated environment.

Key Responsibilities:
• Collaborate cross-functionally with site teams to implement work order and preventative maintenance systems for laboratory equipment.
• Review and contribute to validation documentation to support onboarding of equipment and computerized systems.
• Draft, revise, and review technical and quality documentation such as SOPs, test methods, technical assessments, validation reports, trend reports, and safety evaluations.
• Assist in the procurement of laboratory consumables and critical reagents required for startup activities.
• Coordinate and execute training and method transfer activities for instruments including H/UPLC, TOC, Conductivity, Osmolality and other chemistry-based platforms.
• Actively participate in audits, quality initiatives, and cross-functional projects with site or global impact.
• Provide routine operational support during weekends and public holidays as required.

Preferred Qualifications:
• Bachelor's degree or higher in Chemistry, Compendial testing or a related scientific discipline.
• Minimum of 4 years of relevant laboratory experience in a GMP pharmaceutical or biopharmaceutical manufacturing environment, with a strong background in analytical testing.
• Proficient in analytical laboratory techniques and instrumentation.
• Familiarity with laboratory systems such as LIMS and LMES/CIMS.
• Demonstrated understanding of industry regulations, data integrity, and compliance standards.
• Strong technical writing, documentation, and communication skills.
• Experience with method validation, verification, and transfer.
• Excellent interpersonal skills with the ability to collaborate across teams and adapt to varying communication styles.]]> Wed, 08 Apr 2026 00:00:00 EDT 1 We need employees who are able to work within a CEA sterile cleanroom environment and are able to gown up to do so. Also, we have several COS cells within our department so being able to work in cell environment on their feet is an expectation as well.

Responsibilities may include the following and other duties may be assigned. Operates lightduty bench or floortype machine tools and equipment such as small lathes, power mills, extruding machines, can gown up and work in a clean room environment, Can work in a cell environment, drills or punch presses, power brakes, shears or saws. May set up machining machines and make adjustments, and perform maintenance on machines. Checks work using prescribed gauges, jigs and fixtures to measure close tolerances. Some machines may be numerically controlled. May monitor and verify quality in accordance with statistical process or other control procedures.

PRODUCTION SUPPORT CAREER STREAM: Provides support in manufacturing operations and/or distribution centers including assembly, machinery, processing, packaging, and/or distribution of company products. May set up and operate automatic or semiautomatic machines and related equipment in a continuous production/processing operation. Reports any malfunctions or abnormalities in machines, with higher levels recommending and/or making adjustments to methods and processes. May be involved in shipping, receiving, inventory control, or storage of products in distribution centers.

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor who provides assistance and training to lower level employees. Works under limited supervision, with no instruction needed on routine work and general instructions given on new activities. Thoroughly knows operating equipment and established operational procedures. Performs a wide variety of nonroutine clerical tasks and may support special projects or assignments in distribution center.

Organizational Impact: Performs activities requiring considerable judgment and may have ownership of minor projects in manufacturing/production operations or distribution center. Work may include nonroutine activities related to new lines of work or special assignments.

Innovation and Complexity: Problems faced are general, and may require some analysis to understand and resolve. Expected to independently propose solutions to problems for supervisor review . May be responsible for recommending making minor changes in systems and processes to solve problems or improve effectiveness of own job area .

Communication and Influence: Communicates typically with internal and external contacts, as needed. Obtains and provides information on matters of moderate importance to the job area.

Leadership and Talent Management: Responsible for providing guidance, coaching and training to other employees within job area.

Required Knowledge and Experience: Requires broad knowledge of operational systems and practices typically gained through prior work experience and/or education. Requires minimum of 4 years of experience and may require vocational or technical education or certification in addition to prior work experience. May require vocational training and/or certification.]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

1. Can you please confirm your top 3 skills sets required?
   1. Portfolio-wide strategy/planning for post-market product maintenance. We receive inputs on product changes from across the org, and we need to plan the timing/order of incorporating these changes into the finished goods/eManuals to support global distribution while avoiding stockouts, meeting regulatory and compliance deadlines, expediting safety-related changes, etc. Strategic thinking and planning is important.
   2. Effective program leadership in a regulated environment plus a matrixed organization. We lead teams that are dispersed across multiple sites, working in different environments. Need to be effective at planning schedules, leading teams, meeting facilitation, risk management, project management, partnering with other project managers across the org, etc.
   3. Communications, progress monitoring, and reporting. Ownership of project budgets (financial planning, monitoring, and reporting), product release roadmaps (timelines for changes and new product releases across the portfolio), monthly progress reporting (to leadership, with peers / cross-functional leaders, etc.)
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
   1. Project intake & Release Planning (gathering inputs on detailed changes, thinking through and documenting the strategy for implementing changes in final pack / eManuals to meet deadlines and minimize frequency of changes)
   2. Monitoring and controlling in-process release projects (leading the core release team, manufacturing site team, translations team, etc.)
   3. Maintaining effective communication (release roadmaps, schedules, release plans, proforma/budget tracker, etc.)
3. What products (if any) will this role support?
   1. This position will support across all Neuromodulation and Pelvic Health products, but with a focus on TDD.
4. What is your target years of experience?
   1. Four years of work experience plus Bachelor’s degree, at least two years of Project Management experience
5. When do you plan to start interviewing?
   1. Within the next two weeks
6. Will you be looking to hire and start ASAP or will the start date be delayed? 
   1. Start beginning of May, if we can make that happen.
7. Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?
   1. On site 4 days per week. Can work remotely on Fridays.

______________________________________________________________________________________________

The Product Release Program Lead is responsible for leading, establishing, and driving execution of product release cadences for the Neuromodulation and Pelvic Health (NMPH) portfolio of products. Projects within scope will include but are not limited to: Release Product Engineering (RPE), CAPAs, Sustaining Engineering, and New Product Introduction. This position requires broad cross-functional knowledge and comprehensive business management skills. 

 

A Day in the Life

·         Accountable for overall project execution. Including: project planning, budgeting, schedule creation, and execution.

·         Establishes product release strategy through multiple project inputs, establishing operational plans and execution.

·         Leads and manages site-specific and cross-functional teams established with the purpose of successfully accomplishing the objectives of the product release program.

·         Monitors progress toward pre-established objectives, assesses risks, and implements strategies to ensure successful program execution.

·         Directs the work of site-specific and cross-functions through a matrix organization.

·         Secures site-specific and cross-functional commitments, maintaining milestones and budget. Deploys team resources to meet project/program objectives.

·         Maintains effective communication and interface with various leadership teams.

·         Ensure effective project transition relevant to development, quality, manufacturing, distribution, regulatory, and commercial entities.

·         Provides input to Functional Managers on team member performance, as needed.

·         Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.

·         Develops mechanisms for monitoring and reporting project progress and for intervention and problem solving with project managers, line managers, and clients.

·         Ensures the project/program complies with all aspects of the quality policy/system.

·         Ensure appropriate departmental resources are assigned to the program/project and are available to effectively maintain the quality system (people, facilities, tools, and training).

·         Problems and issues faced can be complex, difficult and undefined, requiring detailed information gathering, analysis and investigation to understand the problem.

·         Other responsibilities, as required and assigned.

 

Must Haves

·         Bachelor’s degree with 4+ years of job-related experience -OR- Master’s degree with 2+ years of job-related experience

·         2+ years of project management experience

 

Nice to Haves

·         2+ years coordinating manufacturing site activities.

·         5+ years in medical device product development, or other highly regulated environment.

·         Project Management Professional (PMP) certified.

·         Experience working with FDA, ISO, EN, and/or GMP standards.

·         Highly developed skill set in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes.

·         Excellent downward, lateral, and upward communication skills.

·         Good balance of high level strategic and detailed tactical thought processes.

·         Demonstrated track record of successfully leading projects/programs to completion.
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Drug Safety Associate

Responsibilities

• Ensure timely and accurate processing of adverse event reports in accordance with company policies and regulatory requirements
• Conduct thorough investigations and evaluations of adverse events, including reviewing medical records and collaborating with cross-functional teams
• Maintain a thorough understanding of product safety profiles and provide timely updates to internal stakeholders
• Monitor and analyze safety data to identify potential safety issues or trends and recommend appropriate actions
• Develop and maintain strong relationships with external partners, such as regulatory agencies and contract research organizations
• Assist with the development and implementation of pharmacovigilance processes and procedures
• Ensure compliance with all applicable regulations and guidelines related to pharmacovigilance
• Participate in cross-functional meetings and contribute to the development of risk management plans for products
• Support the preparation and submission of regulatory reports and responses to safety-related inquiries
• Collaborate with other departments, such as Clinical Development and Medical Affairs, to ensure the safety of products throughout their lifecycle
• Maintain accurate and up-to-date documentation of all pharmacovigilance activities
• Handling administrative tasks related to safety reporting, including filing, preparing cover letters, managing translations for required local languages, and completing submission forms as
• Working with minimal supervision, will oversee all aspects of pharmacovigilance (PV) safety reporting from project start-up through close-out, according to the agreed scope of work
• Participates in project teams, and where required provides training and support to team members in respect of safety reporting

 

Qualifications

• Education – bachelor’s degree or equivalent professional experience
• Previous experience of 2+ years of Pharmacovigilance / Drug Safety in a CRO or Pharma, Biotech environment.
• Preferably, experience of safety report distribution and submission, as well as healthcare administrative
• Training – Strong understanding of Good Clinical Practices (GCPs) and familiarity with global safety reporting regulations, including those from EMA, FDA, MHRA, other regions, and ICH guidelines
• Exceptional attention to detail with a focus on accuracy and meticulous
• Ability to multi-task, prioritize, and manage time effectively to handle multiple project assignments
• In-depth understanding of global and local pharmacovigilance (PV) regulations
• Understanding of medical terminology and familiarity with coding dictionaries g
• Experience with ArisG or a similar Safety Database a plus.
• Strong project management, interpersonal, verbal and written communication

]]> Wed, 08 Apr 2026 00:00:00 EDT 0 Join Our Team as a GDP QA Specialist – Warsaw, Poland

Are you passionate about ensuring the highest standards in pharmaceutical quality assurance? We are seeking a dedicated and detail-oriented GDP QA Specialist to join our team near Warsaw. This pivotal role offers the opportunity to contribute to a leading global organization, working at a distribution warehouse outside Warsaw, and supporting compliance in a fast-paced pharmaceutical environment. If you thrive in a collaborative setting and possess a strong background in GDP QA, we want to hear from you!

What You Will Do:

• Oversee and ensure compliance with Good Distribution Practice (GDP) standards.
• Support quality assurance activities at a distribution warehouse location outside Warsaw.
• Collaborate with on-site teams to maintain quality and regulatory standards.
• Conduct audits, review documentation, and implement quality improvement initiatives.
• Maintain strict adherence to pharmaceutical regulations and company policies.

Required Skills:

• 2-4 years of experience in pharmaceutical QA, specifically within GDP environments.
• Fluent Polish language Skills.
• Strong English language proficiency (C1/C2 level).
• Excellent attention to detail and strong analytical skills.
• Knowledge of pharmaceutical regulations and compliance standards.
• Ability to work independently and as part of a team.

Nice to Have Skills:

• Prior experience working in pharmaceutical distribution or warehousing.
• Knowledge of additional languages.
• Experience with internal audits and quality systems.
• Familiarity with international pharmaceutical regulations.

Preferred Education and Experience:

• Bachelor’s degree in Pharmacy, Life Sciences, or a related field.
• Proven track record in pharmaceutical QA roles, preferably within a similar setting.

Other Requirements:

• The role is based primarily onsite at a distribution warehouse, with 4-5 days per week expected on-site.
• This is a 12-month contract position.

Take the next step in your pharmaceutical QA career by applying now. We’re excited to review your application and explore how you can contribute to our quality-focused team!
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Exciting Opportunity: Clinical Quality Assurance Lead (GCP) – Central & Eastern Europe (CEE) – Remote

Are you a dedicated quality professional with a passion for ensuring the highest standards in clinical research? We are seeking a proactive and detail-oriented Clinical Quality Assurance Lead specialized in GCP to join our dynamic team supporting the healthcare and pharmaceutical industries across CEE. This is a critical role that offers the chance to influence compliance excellence in a fully remote setting, with minimal travel, and to work on impactful projects for a leading organization.

In this hands-on leadership position, you will serve as a key quality expert, guiding audits, regulatory inspections, and process improvements. Your expertise will directly support our clients’ success and ensure our clinical operations meet rigorous GxP standards. If you are ready to make an immediate impact and thrive in a collaborative, fast-paced environment, we want to hear from you.

Required Skills:

• Minimum of 2 years' experience leading GCP audits within a clinical or pharmaceutical setting.
• Proven expertise in GxP quality management systems, including audit preparation, conduct, reporting, and CAPA management.
• Strong understanding of regulatory compliance, GCP guidelines, and inspection readiness.
• Excellent written and verbal communication skills in English with the ability to articulate quality issues clearly.
• Proficiency with Microsoft Office Suite and Adobe Acrobat.
• Exceptional attention to detail, problem-solving skills, and the ability to prioritize multiple tasks.
• Ability to work independently in a remote environment and collaborate effectively with cross-functional teams.
• Willingness to travel at least 5%, including internationally.

Nice to Have Skills:

• Previous experience in a Clinical Research Organization (CRO) setting.
• Knowledge of computerized systems validation and quality documentation.
• Experience preparing for and hosting client audits and regulatory inspections.
• Familiarity with quality management system software (eQMS).
• Additional language skills relevant to the CEE region.

Preferred Education and Experience:

• Bachelor’s degree in a related field or equivalent work experience in the pharmaceutical, biotech, or healthcare industry.
• At least 5 years of quality assurance experience in regulated environments, with a strong focus on clinical trials and GCP compliance.
• Demonstrated experience in a lead or audit capacity, supporting inspections and regulatory queries.

Other Requirements:

• Ability to adapt to fluctuating business needs and prioritize effectively.
• Flexibility to travel internationally, approximately 5% of the time.
• Urgent availability desired, with the ability to start promptly.
• Commitment to maintaining confidentiality and the highest professional standards.

Take the next step in your career by joining a global organization committed to improving healthcare outcomes. Apply now and be part of a team that values expertise, initiative, and a passion for quality excellence. Your expertise can make a real difference in advancing innovative therapies and patient care worldwide.
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 The Opportunity:  Manager, Regulatory Project Management

Seeking a Manager, Regulatory Project Management to support execution of regulatory planning and major submission activities across our development portfolio. This role will serve as a key operational partner and back-up to the Regulatory Planning lead, helping ensure continuity, cross-functional alignment, and disciplined delivery of regulatory milestones. The Manager will play an integral role in supporting complex submissions by translating regulatory strategy into structured, actionable project plans and driving accountability across cross functional contributors. Working closely with Regulatory Science, Regulatory Operations, and cross-functional stakeholders, this individual will enhance visibility into timelines, proactively identify risks, and help enable efficient, high-quality regulatory execution in a dynamic environment.

• 
  Serve as back-up to the Regulatory Planning lead, ensuring continuity of regulatory planning activities and timeline oversight.
  
• 
  Support development and maintenance of integrated global regulatory timelines across programs.
  
• 
  Provide project management support for major submissions, including complex regulatory submission planning and milestone coordination.
  
• 
  Facilitate Global Regulatory Strategy Team meetings, including agenda coordination, minute-taking, action item tracking, and follow-up with functional team members.
  
• 
  Develop and maintain detailed submission delivery plans and milestone trackers.
  
• 
  Monitor progress against commitments and proactively surface risks, dependencies, and resource considerations.
  
• 
  Prepare clear status updates, dashboards, and planning materials for internal stakeholders.
  
• 
  Coordinate with Regulatory Operations to align planning outputs with document readiness and submission execution.
  
• 
  Assist with health authority meeting logistics and cross-functional preparation activities.
  
• 
  Contribute to enhancement of regulatory planning tools, templates, and processes.
  

Required Skills, Experience and Education:

• 
  Bachelor’s degree in life sciences or related discipline.
  
• 
  5+ years of experience in regulatory affairs, regulatory operations, or regulatory project management within biotech or pharmaceutical industry.
  
• 
  Experience supporting a major regulatory submission (e.g., NDA, BLA, MAA).
  
• 
  Working knowledge of global regulatory submission processes and lifecycle management.
  
• 
  Demonstrated ability to build and manage detailed project timelines in a cross-functional matrix environment.
  
• 
  Strong meeting facilitation and follow-up skills, with proven ability to drive accountability.
  
• 
  Proficiency with project planning tools (e.g., Smartsheet, MS Project, or similar platforms).
  
• 
  Excellent organizational skills and attention to detail.
  
• 
  Strong written and verbal communication skills.
  

Preferred Skills:

• 
  Experience supporting NDA submissions in oncology or complex development programs.
  
• 
  Familiarity with eCTD structure and regulatory publishing workflows.
  
• 
  Experience with Regulatory Information Management (RIM) systems.
  
• 
  Proficiency in timeline visualization tools (e.g., OnePager, TimelinePro).
  
• 
  PMP certification or formal project management training.
  
• 
  Demonstrated ability to influence cross-functional teams without direct authority.
  

]]> Wed, 08 Apr 2026 00:00:00 EDT 0 We are supporting a medical devices organisation seeking an experienced Area Sales Manager to drive growth across the Perth region within orthopaedics. This role focuses on knee and hip reconstruction solutions and requires strong clinical understanding and a track record of commercial success within theatre based environments.
The Opportunity
You will manage all sales activity across the territory, build strong relationships with surgeons and theatre teams, support clinical cases, and ensure the successful adoption of orthopaedic implants and technologies. You will take ownership of the region, grow market share, and deliver high quality commercial and clinical support.

---

What You Will Do Territory and Customer Management
• Manage all commercial activity across the Perth region, building deep relationships with surgeons, theatre staff, and wider clinical stakeholders
• Develop and execute territory plans that drive growth across knee and hip portfolios
• Support surgical procedures in theatre to ensure product confidence and successful outcomes
Sales Growth and Account Development
• Identify new business opportunities and convert competitive accounts
• Increase product adoption through effective education, product expertise, and consultative selling
• Maintain high levels of product knowledge across all orthopaedic solutions within the portfolio
Clinical Support and Training
• Provide in theatre case support for knee and hip procedures
• Deliver training and product education to clinical teams
• Support workshops, demonstrations, and regional education events
Market and Competitor Insight
• Maintain awareness of competitor activity and market dynamics
• Provide continuous feedback to the commercial and marketing teams to refine strategy

---

About You
• Experience in orthopaedic medical devices with strong knowledge of knee and hip reconstruction
• Proven track record in territory sales within theatre based environments
• Strong relationship builder with excellent customer focus
• Confident in theatre, comfortable supporting cases and providing product guidance
• Commercially driven with strong planning and organisational skills
• Clear communicator who can influence at all levels
• Based in Perth or willing to be located in the territory
]]> Wed, 08 Apr 2026 00:00:00 EDT 1
RESPONSIBILITIES:
• Preparation and extraction of samples for GC/MS confirmation in the forensic toxicology laboratory
• Safely operate, monitor and troubleshoot laboratory equipment to ensure proper functionality
• Prepare, test and evaluate new reagents, controls and calibrators in compliance with SOPs and regulatory guidelines
• Perform and document preventative maintenance and quality control procedures
• Sound technical decision-making regarding testing and problem solving
• Storage of and replenishment of supplies as needed
• Adherence to all security procedures for ensuring confidentiality of donor information
• Adherence to all established guidelines outlined in Employee Handbook
• Must comply with company policies
• Maintain a safe work environment and wear appropriate personal protective equipment at all times

BASIC QUALIFICATIONS | EDUCATION:
• Minimum requirements are:
• Bachelor's degree in Biology, Chemistry, or Medical Technology
• Minimum 1 year of clinical laboratory testing experience is required for Technologist level
• Ability to work independently and within a team environment
• Proficient with computers; Familiarity with laboratory information systems are a plus
• High level of attention detail along with strong communication and organizational skills
• Must be able to pass a standardized color vision screen
• Flexibility to work overtime or other shifts depending on business needs

COMPETENCIES:
• Ability to lift and/or move 25 pounds
• Ability to have full body movement
• Must have vision and hearing corrected to meet minimum acceptable norms
• Ability to cope with stress due to production obligations
• Ability to read and comprehend the SOP, Federal (49 CFR Part 40), and CAP-FUDT guidelines
• Ability to communicate with other employees and supervisors
• Ability to provide input and recommendations on operations
• Climate-controlled office and testing laboratory environment
• May be potential exposure to toxic or hazardous materials

Required Business Travel Requirements:
• Domestic travel may be required when subpoenaed to testify in legal proceedings. Travel to other domestic Alere offices may also be required

Mental/Reasoning Requirements:
• The following are the mental requirements of the position as it is typically performed. Inability to meet one or more of the mental requirements will not automatically disqualify a candidate or employee from the position. Upon request for a reasonable accommodation, the Company may be able to adjust or excuse one or more of these requirements, depending on the requirement:
• Math and reasoning ability to develop and communicate laboratory procedures and reports
• Ability to cope with stress due to production obligations
• Ability to cope with stress induced during legal proceedings
• Ability to read and comprehend the SOP, Federal (49 CFR Part 40), and CAP-FUDT guidelines
• Ability to transcribe data in a legible handwriting
• Ability to communicate with other employees and supervisors
• Ability to provide input and recommendations on operations
Additional Comments:
The individual may be required to work varying shifts or weekends to perform the Essential Functions

The max pay rate is 19/hr for this position ]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

Can you please confirm your top 3 skills sets required?

#1 – I’m looking an engineer who doesn’t feel they must be doing hardcore research and development to provide high value.  Looking for someone that is capable and interested in solving problems and achieving results, whether or not the problem statement is highly technical.

#2 - Engineering design change management/documentation in a regulated environment.

#3 – Recent demonstrated capability in basic engineering skills such circuit schematic design/comprehension and benchtop electrical testing with various lab equipment.

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

#1 – Performing product failure analysis.

#2 – Processing engineering change records in Agile and Windchill.

#3 – Taking work direction from senior engineering staff to satisfy various engineering tasks as needed.

What products (if any) will this role support?  CRM market released Instruments (non-implanted medical devices) such as pacemaker programmers, home monitors, patient assistants, and temporary external pacemakers.

What is your target years of experience?  Open to 0-5 years of experience with a target of 2-3.



This position is for a junior to mid level electrical engineer to provide assistance to the CRM Instruments HW Released Product Engineering group (a.k.a. continuation engineering, sustaining engineering, product support).  This group participates in several cross functional teams for market released external medical instrumentation products. Cross functional project teams include members from Product Development, Manufacturing, Marketing, Sourcing, Contract Manufacturing Engineering, Quality, Reliability, and Regulatory functions. The group’s primary objective is to provide the design expertise necessary to support continuity of quality and compliant products.  This electrical engineer will be taking work direction from the engineers on staff to fulfill various technical and documentation responsibilities.

**Position Responsibilities:

* Assess supplier driven changes, component changes, and component obsolescence for potential impact against product functional requirements and document the testing required or rationale (analysis) for no testing.

* Create test plans and reports, and coordinate product testing.

* Evaluate returned product to determine the root cause of field returns and establish design improvements.

* Create and implement engineering changes in the Product Data Management system. This includes leading the cross functional change review and approval process.

* Communicate technical details and achieve the necessary understanding and trust from non-technical audiences.

* Provide technical expertise to support electrical and mechanical projects that expand the capabilities of existing product and system solutions.

* Review and analyze circuit schematics and technical component specifications.

* Design, simulate, and test analog and digital circuits either independently or while working closely with a design technician for the development of improved solutions and evaluation of returned product.

* Generate high quality formal documentation and records.

* Manage, configure, track, verify, and transport test samples.

* Assess the impact of changing regulatory standards on existing medical products and assess the impact of changes in medical products against existing regulatory standards.

* Typical issues are reactive and are often urgent, so priorities change frequently, and issues must be resolved quickly to assure quality and continuity of supply.  Some issues requiring resolution may contain a mechanical element as well. Leverage area expertise and learn new design elements to quickly become the design expert as issues require.

**Required Qualifications:

* 0 to 5 years industry experience

* Bachelor of Electrical Engineering or another Engineering with a very strong focus in electronics

* Must have the capability of functioning independently as an Electrical Engineer with minimal supervision

* Skills include analog/digital circuit design and troubleshooting, laboratory practices, circuit simulation, product testing, and design of experiments

* Demonstrated problem solving skills

* Strong written communication skills

* Proven experience working effectively both independently and with multi-functional teams.

**Desired Qualifications:

* Experience in a regulated industry (e.g. medical, aerospace, military).

* Experience in the development or support of medical products

* Experience with evolving technology such as USB, Bluetooth, mobile (cellular) technology, and WiFi

* Experience in manufacturing or post market support

* General understanding of how to interpret and apply industry recognized standards, especially for medical electronic products

* Strong verbal skills

* Experience with quick turn assignments
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Remote
 
HM's Top Needs:

1. CCI CRAT or CCT certified

2. IBHRE Pacemaker/ICD experience 3 years +

3. Medical device or cardiac experience 2+ years
 

Education Required:

 Bachelor's degree in Health Sciences, Biology or a related field preferred.

Years’ Experience Required:

2-5 years related work experience required in cardiac monitoring and analysis.

Will the contractor be working 40 hours a week? If not, weekly estimate?

40 hours per week with the possibility to flex to less if experience was right

The Assoc Clinical Data Specialist (Cardiac Technician) Identifies normal and abnormal findings during basic device EGM or ECG reviews and analyze data form patient devices using knowledge and understanding of diagnostic and therapeutic procedures. Works with scientists and research members to accurately label and use findings for AI development, clinical studies and research protocols

Essential Responsibilities:

1.      Identifies normal and abnormal findings during basic device interrogations, ECGs or EGMs. This includes ICM’s, pacemakers, ICDs, and cardiac resynchronization devices.

2.      Reviews and analyze data with research groups and clinical data team of findings to help assist research members in study protocols

 
Responsibilities:

- Review Cardiac Implantable Electronic Device data and provide quality analysis of the data and accurate annotation review

- Collaborates with various departments on annotation and understanding annotation review and implementation of annotation labels for purposes of AI development

- Delivers annotation projects assigned and works with other stakeholders to achieve desired results. 

- The majority of time is spent delivering implantable device EGM/ECG annotation review and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

 

NICE TO HAVES:

-          IBHRE/CCI RCES or 2-5 years minimum of EGM annotation experience

-          ECG Annotation experience minimum 2-5 years

 

MUST HAVES

-          Education Required: Bachelors Degree

-          Years’ Experience Required: 2 -5 years minimum.

-          CCI CRAT/CCT
 

Role Hours and Location: 40 hours per week. Flexibility in hours is allowed after 4-6 week training period. Role is 100% Remote. Hybrid is available if requested
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 *depending on experience

MUST haves -

5+ years' directly relevant experience in:
• Agency recruitment - headhunting and recruiting contractors/consultants (not just direct hire positions)
• Pharma/Biotech cGMP industry experience
• 2+ years' minimum experience headhunting senior- and executive-level, technical roles.
o roles like Senior Automation Engineers, Principal Validation Engineers, Senior Project Managers (pharma industry), Capital Project Managers, Capital Project Design Engineers (greenfield sites)
• Extensive experience in LinkedIn Recruiter, hunting for qualified talent and conducting InMail outreach and follow-up]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

Can you please confirm your top 3 skills sets required?

?Systems engineering, medical device design, strong written/verbal skills
 

Nice To Have

• neuromodulation, experience with system modeling, interface design, working with standards and regulations, strong verbal and written skills

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

?Reviewing and authoring technical documentation (including requirements and design implementation), cross-                     functional collaboration, managing/prioritizing tasks and workload alongside project schedules

What products (if any) will this role support?

??Pelvic health - tibial neuromodulation 

What is your target years of experience?

?3-8 years

 

Responsibilities may include the following and other duties may be assigned. Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Wed, 08 Apr 2026 00:00:00 EDT 1

Can you please confirm your top 3 skills sets required?  System Integration Experience, System Verification Experience, EE or ME or SW degree.

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Develop Tests, Execute Tests, Identify Issues with the product (failed tests)

What products (if any) will this role support?  Medtronic Spinal Cord Systems – Patient Instruments, Implantable Stimulators, and External Stimulators

What is your target years of experience?  5-10

When do you plan to start interviewing?  Early April

Will you be looking to hire and start ASAP or will the start date be delayed?  Starting First Week of May 2026.

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  Both, at least 4 days a week onsite.
_____________________________________________________________________________________________
Responsibilities may include the following and other duties may be assigned. Performs technical planning, system integration, verification and validation, evaluates alternatives including cost and risk, supportability and analyses for total systems. Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal. Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Target Pay Rate: 40-53/hr **salary will be commensurate with experience 

Summary
In the Systems Engineer role, you will be supporting the overall technical direction of Acute Therapies products. Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management. Tasks may include product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.

What you'll be doing:
• Perform the activities associated with the systems engineering of one or more products in various stages of the product lifecycle from new product development to post-market surveillance
• Understand clinical and user needs and apply them to product realization
• Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc.
• Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective
• Craft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area
• Create and maintain design history file elements
• Facilitate an improved understanding of the interrelationship between requirements, risk and reliability
• Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal results
• Resolve systems-related technical issues by applying problem-solving tools such as cause-and-effect diagrams, Pareto charts, etc.
• Propose and drive solutions to technical problems that are ambiguous and diverse in scope
• Perform impact assessments on the requirements on an ongoing basis for any proposed design / material / process changes or observations from field / service / manufacturing. As needed, propose recommended mitigations with rationale.
• Influence stakeholders and cross-functional team members within the project
• Drive adherence to FDA, ISO and IEC design control procedures, regulations and standards
• Use various software tools and programs to complete the above responsibilities

What you'll bring:
• Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains
• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
• A track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military
• Prior experience with internet-connected, software-enabled devices and/or cyber security
• Working knowledge of system modeling language (SysML or UML) and requirement management tools
• Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM preferred
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
• Success in working with multi-functional, global teams
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Demonstrated strong analytical and problem-solving skills
• Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders
• Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks
• Ability to deliver results according to the plan

Experience and/or Background:
• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• Three or more years of relevant experience]]> Wed, 08 Apr 2026 00:00:00 EDT 1 The Opportunity:   Commercialization Contracts Operations Senior Manager

The Commercialization Contracts Operations Senior Manager is essential to execution and achievement of goals and objectives across the Commercialization Function (including Medical Affairs, US Commercial, and Global Commercial functions) at Revolution Medicines.   This role requires strong process management and execution, compliance management, cross functional and vendor collaboration, process optimization, the ability to thrive in ambiguity, and a passion to build and optimize critical business processes. This role will work independently across functions and teams as a trusted partner to proactively manage the efficient tracking, execution and management of Commercialization contracts.

• 
  Execute and manage a growing large volume and variety of contracts (SOWs, CDAs, MSAs) through collaboration with Legal, Contracts and Compliance teams and Business Contract owners with minimal oversight.
  
• 
  Ensure efficiency and compliance of all contracts with company policies, legal requirements, and industry regulations.
  
• 
  Provide training and guidance to new business contract owners on contracting obligations and processes to ensure adherence to legal and compliance standards.
  
• 
  Monitor contract lifecycles, including renewals, amendments, and terminations to ensure timely and compliant management.
  
• 
  Be the liaison and point of contact for business contract owners and vendor/agency inquiries related to contracting and payment in partnership with legal, finance, and procurement. Manage timely and proactive communications with stakeholders.
  
• 
  Leverage understanding of business needs to create prioritization framework and resolve competing urgent business priorities.
  
• 
  Maintain contract management system and tracker to manage and prioritize the volume to ensure timely execution and follow through of fully executed contracts to POs.
  
• 
  Set a vision and plan for process optimization and work with stakeholders across business, legal, contracts & compliance and finance functions to drive enhancement efforts.
  
• 
  Work closely with Commercial Development Operations and Medical Excellence Operations team members to address business needs while optimize contracts administration.
  

Required Skills, Experience and Education:

• 
  Bachelor’s degree required with 5+ years of relevant experience in contracts administrative and operations role (procurement, contract management, or purchasing departments) pharmaceuticals or biopharma industry.
  
• 
  Track record of being a collaborative team player and business partner, building positive partnerships and adaptive to meet the needs of a growing business.
  
• 
  Strong critical thinker and problem solver with proactive mindset to build and manage processes and systems that drive accountability and results.
  
• 
  Demonstrated ability to influence management and key business partners without authority.
  
• 
  Excellent organizational skills, ability to multi-task, and prioritize effectively to deliver results within reasonably established timelines.
  
• 
  Strong interpersonal skills including verbal and written communication and represent company and embodies our corporate values.
  
• 
  Proficient in Powerpoint, Excel, Word, and variety of project management (ie, smartsheets) and communication and administrative platforms (ie, Teams, contracts management system, etc).
  

Preferred Skills:

• 
  Targeted Oncology product experience preferred.
  

• 
  Prior experience working in a fast-paced, matrixed biotech or pharmaceutical environment.
  
• 
  Familiarity with emerging digital tools for Medical Affairs and Commercial functions.
  

]]> Wed, 08 Apr 2026 00:00:00 EDT 0
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Digital Experience is shaping the future of how the company connects with our patients and customers by harnessing the power of digital innovation and human-centered design. As healthcare evolves, we are bold in our approach – leveraging cutting edge AI, advanced digital engagement, end-to-end content management, and omnichannel technologies and operations to create seamless, personalized, and meaningful experiences for our patients and customers. This
is your opportunity to lead transformative change, integrating advanced technology with strategic vision to drive impact at scale. If you are passionate about redefining the healthcare experiences and building something extraordinary, we want you on this journey. Let’s redefine
what’s possible together!

This combined team, in collaboration with key partners, builds solutions to serve Marketing, Customer Engagement, Medical Affairs, Public Affairs & Access (“CMG”), and other patient- and customer-facing teams across CMG to shape and drive a seamless, consistent, meaningful, and compliant experience for patients and customers across our interactions. The team is specifically accountable for:

? Defining omnichannel solutions, shaping engagement strategies, designing,
operationalizing, and producing seamless, consistent & meaningful patient and
customer experiences.
? Accelerating, connecting, and enabling the development of digital solutions that enhance the patient and customer experience across CMG.
? Advancing the mission of seamless, consistent & meaningful patient and customer experiences that maximize patient impact while keeping compliance at the forefront.

Job Summary
The Senior Business Product Manager, Healthcare Professional (Patient) Customer Relationship Management (CRM) drives the development, adoption, and continuous improvement of the Patient CRM Product, as well as core integrated capabilities such as e-detailing, customer insights modules, messaging etc. Partnering with the Business Product Owner, Executive Director - CRM
Suite Leader, and Technical Product Manager, this role defines product roadmaps, gathers user insights, and drives feature rollouts.
This role is closely integrated with commercial, medical, and other cross-functional teams that leverage CRM to support both digital and in-person customer engagement. Through these deep, wide-ranging connections, the individual in this role will develop a strong understanding of how
CRM strategies and capabilities shape customer experiences, contribute to business outcomes, and empower CRM end-users to deliver meaningful impact.

Key Responsibilities
? Partner with the Business Product Owner and/or Executive Director - CRM Suite Leader to support the creation of digital-forward healthcare provider customer relationship (Patient CRM) product roadmaps, including experience, features, timelines, and dependencies.
? Partner with Technical Product Manager to drive the development and improvement of
Patient CRM product or specific product features, ensuring alignment with the overall Patient CRM product vision.
? Help evangelize the role of product(s) in achieving enterprise objectives, communicating their value proposition and roadmap(s) to senior leaders and organization-wide
stakeholders.
? Act as point of contact for business feedback, recommendations, & user requests for enhancements to the Patient CRM product.
? Collaborate with the Technical Product Manager to align business outcomes with technical feasibility, ensuring the Patient CRM product delivers both business value and technical performance.
? Oversee business process & user insights collection through User Acceptance Testing
(UAT) to ensure the successful implementation of new features and capabilities.
? Support the rollout of new features across new and existing users.
? Collaborate with Business Product Owner / Executive Director - CRM Suite Leader to establish business standards & templates and ensure pull-through.
? Drive definition of business requirements for Patient CRM product capabilities and features and non-functional performance requirements, leveraging GNE and industry standards.
? Drive experimentation to enhance Patient CRM product offerings, in line with the overall business learning agenda.
? Coordinate with business stakeholders, IT, and cross-functional enterprise product team partners to align on the product roadmap, fostering cohesive collaboration and unified efforts toward shared goals.
? Collaborate with cross-functional teams and IT partners to ensure successful Patient CRM
product integration and execution.
? Closely partner with Customer Experience professionals to ensure Patient CRM product experience meets the expectations of its end-user product community.
? Understand customer engagement trends and technologies in the pharmaceutical industry. Track market shift and emerging technologies to inform CRM strategy and
roadmap development.
? Comply with all laws, regulations and policies that govern the conduct of  activities.
? Ensure Patient CRM product features align with compliance, privacy, and regulatory standards while supporting effective field force engagement.
? Collaborate with FieldSales, Medical, and Marketing teams to define and prioritize functionality that supports timely and personalized Patient interactions.

Who You Are
Minimum Candidate Qualifications & Experience
? Bachelor’s degree in business, technology, operations, science, marketing, or a related field.
? 7 years of experience, with 5 years in product management, digital product operations, or equivalent experience.
? Experience with sole ownership of tactics or product components, demonstrating the ability to articulate business problems, identify solutions, and drive execution from strategy through implementation.
? Demonstrated ability to develop and execute product roadmaps, including feature planning, timelines, and dependencies.
? Experience with User Acceptance Testing (UAT) and rolling out new features across a variety of user bases.
? Proven success in aligning stakeholders and collaborating with cross-functional teams to deliver seamless product integration.
? Strong analytical and problem-solving skills, with experience driving experimentation and optimization.
? Exceptional communication and presentation skills, with the ability to evangelize product vision and value across all levels of an organization.
? Proven ability to adapt and navigate ambiguous or evolving environments.
Additional Desired Candidate Qualifications & Experience
? Advanced degree, or equivalent experience (e.g., MBA or related graduate-level qualification).
? Experience in healthcare, pharmaceutical, or highly regulated industries.?
Ability to innovate and foster experimentation to improve product capabilities.
? Experience in leading or managing enterprise CRM platforms (e.g., Veeva, Salesforce) within life sciences or healthcare industries.
? Strong understanding of customer engagement strategies and omnichannel orchestration tailored to Patients.

Location
? This position is based in South San Francisco, CA

Pay rnages between 90-07/hr based on experoence ]]> Wed, 08 Apr 2026 00:00:00 EDT 1 The Laboratory Design Associate prepares 2D/3D designs and construction plans for standalone, analytics-only laboratory solutions. The Laboratory Design Associate supports the development of the laboratory design throughout multiple phases to ensure the successful implementation of the proposed solution. The Lab Design Associate creates basic 3D visualization and digital images to promote the sales opportunity and support marketing needs.

This off-campus position is a part of the Healthcare Consulting Business Operation team and works closely with colleagues, as well as internal and external stakeholders (global business affiliates, field engineers, architects, customers, and others) to address the customers unique design requirements. While this is a remote position, it may require up to 10% overnight travel across the US.

Key Roles and Responsibilities
Transforms Matterport digital twin (BIM files or Point clouds) into formats used throughout the non-automation, solution design lifecycle
Produces detailed concept designs, phasing plans, and construction drawings using 2D/3D CAD software for non-automated solutions
Develops 3D models, renderings, and basic visualizations of laboratory designs using Revit, Enscape, Twinmotion or Unreal Engine
Collaborate on designs with internal and external customers for modifications and final approval
Documents and maintains change requests for concept designs, phasing plans and construction drawings for non-automation solutions
Provides accurate technical specifications and install dimensions to engineers, architects, and facilities team
General working knowledge of building codes, regulations, and standards
Reports progress and status of assignments on a timely basis
Manages multiple projects and tasks to meet the turnaround time demands of the assignment
Works closely with team to provide backup support tasks on projects with tight schedules
Performs other basic drafting and design assignments, special projects and support functions, as needed
Employs all company standards and follows established procedures to deliver quality results in the performance of assigned tasks

Who you are
You are an early-in-career professional CAD designer who pursues experience with lab design, technical layouts, and visualization. You seek to leverage your technical and creative skills to design optimal laboratory solutions that lead to successful implementations. You enjoy collaborating with colleagues, internal and external stakeholders to creatively solve their unique design solutions. You are organized, attentive to detail, and possess excellent time management skills.

Minimum Requirements
1 - 3 years experience with Revit, BIM and other CAD-related software
Completion of an Bachelors Degree in Architectural Design Technology, Interior Design or comparable

Preferred Qualifications
Proficient with 3D design and rendering software (AutoCAD, Revit, Enscape, Unreal Engine, Twinmotion)
Ability to design and read mechanical and architectural drawings
Proficiency in designing products using 3D parametric CAD
Basic knowledge of CAD file management and functionality
General understanding of drafting conventions and best practices
Basic understanding of GD&T
Basic knowledge of Virtual and Augmented Reality Solutions
Basic knowledge of Business Information Modeling (BIM) and Autodesk Construction Cloud (ACC)
General understanding and application of technical principles, theories and concepts in the field
Basic knowledge of other related disciplines and company objectives
Willing and able to travel 10% of the time
Reside within 50 miles of a major US metropolitan airport

Pay ranges between 25-30/hr based on expereince ]]> Wed, 08 Apr 2026 00:00:00 EDT 1 Target PR Range: 20-30/hr
*Depending on experience

Major Responsibilities:
o Planning, scheduling, coordination and execution, in support of clinical supply project manager to ensure the timely availability of investigational drug supplies and related services to clinical sites and depots.
o Translates stability and packaging requests into an executed packaging design.
o Identifies, develops, communicates and tracks task completion dates, activities, logistics, and milestones in support of clinical supply project manager to ensure the timely availability of investigational drug supplies
o Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with the clinical supply project manager.
o Responsible to complete tasks identified for the team.
o Responsible for inventory management system set up activities (i.e. Material masters, manufacturing requests, etc) to support clinical packaging operations
• Critical Success Factors
o A basic understanding of clinical development and global supply chain requirements.
o Competent in the application of standard business requirements (for example SOPs, Global Regulations).
o Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
o Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
o Ability to work effectively and professionally with those in the dept as well as QA, Analytical and any area interface.
o Ability to manage and prioritize multiple tasks.
o Basic Project Management skills.
o Good communication skills (both written and oral).
]]> Tue, 07 Apr 2026 00:00:00 EDT 1 *depending on experience

Responsibilities
• Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).
• Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging.
• Develop and execute packaging test protocols including:
o Transportation simulation (ISTA/ASTM)
o Aging and shelf-life studies
o Cold-chain and environmental conditioning
o Packaging line engineering studies
• Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).
• Prepare and review packaging documentation for regulatory submissions.
• Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs.
• Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
• Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications.
• Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements.
________________________________________
Basic Qualifications
• Bachelors degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
• 7+ years of packaging engineering experience in biopharmaceutical, pharmaceutical, or medical device environments.
• Strong understanding of cGMP, sterile product packaging, and biologics/combination product considerations.
• Experience with packaging validation and ISTA/ASTM distribution testing.
• Excellent communication skills and ability to collaborate across functions.
• Ability to work onsite at Thousand Oaks campus.
________________________________________
Preferred Qualifications
• Masters degree in Engineering or related field.
• Experience with combination products, injection devices, and cold-chain distribution systems.
• Knowledge of paperboard, structural design & FEA]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

This role will be project focused, working with Program management and other engineers to perform root cause analysis and investigation tasks towards optimizing and implementing improvements within both production and pre-production environments. This role will be required to define optimization opportunities based on engineering findings, present to the team, and implement showing improvements within the manufacturing yield/process.

What products (if any) will this role support?

This role will have the opportunity to support products built for pharmaceutical operations (combination steroid/medical device products) and/or Cardiac Surgery.

What is your target years of experience?

Looking for E2 position equivalent. Target years of experience falls within 2-3 years within the medical device manufacturing or development engineering fields. 

When do you plan to start interviewing?  ASAP 

Will you be looking to hire and start ASAP or will the start date be delayed?  Hiring process will be focused on a start date of early to mid Q1 FY27. 

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  Full-time onsite (4+ days)

_______________________________________________________________________________________________________________

Relevant experience in process development deliverables (IQ, OQ, PQ), process characterization work, and equipment development experience is preferred.

Responsibilities may include the following and other duties may be assigned:

• Provide technical and sustaining engineering support within a manufacturing environment.
• Recommend and implement equipment and process modifications to meet quality standards, improve production efficiencies, enhance manufacturing techniques, and increase yields for existing products.
• Integrate equipment and material capabilities to meet process module and technology target specifications.
• Review product development requirements for compatibility with processing methods and provide input on cost and schedule implications.
• Collaborate with product design and development teams to ensure processes and designs are aligned and manufacturable.
• Perform or support statistical analysis and contribute to documentation improvements when needed.
• Lead innovation, development, and optimization of new manufacturing concepts, processes, and procedures for transfer into manufacturing operations, including feasibility assessments, material selection, equipment selection, tooling and fixture development, and evaluation of process inputs and outputs.
• Develop manufacturing processes suitable for statistical process control and support development of measurement systems. Ensure all processes and procedures comply with regulatory requirements.

]]> Tue, 07 Apr 2026 00:00:00 EDT 1

Seeking an External Automation Engineer based in Thousand Oaks, California to augment our MCS F&E Automation team. This role will support ongoing biological processes by updating, maintaining, and improving DeltaV automation systems, and providing critical site support. The successful candidate must exhibit sound analytical thinking and problem-solving skills, exemplary communication and collaboration, and operational excellence. A proven ability to work in cross-functional teams is critical for this role.

Preferred Qualifications:
• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech
Engineering.
• Extensive understanding and background in programming, design, installation and lifecycle
management of manufacturing process controls, automation and field instrumentation
technologies.
• Demonstrated hands-on experience in developing process control strategies for New
Product Introduction and New Technology Deployment for Clinical and Commercial Drug
Substance Plant Operations.
• Direct knowledge of Automation design, experience in process control engineering and
troubleshooting with GMP biopharmaceutical production facility equipment/systems such
as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration,
and integrating various OEM automation software.
• Demonstrated experience with continuous improvements resulting in enhanced safety,
system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.)
related to Drug Substance Plant Operations.
• 5+ years combined experience with the following:
Emerson Delta-V DCS system
Rockwell Automation SCADA and PLC Platform.
Electronic Batch Reporting Systems Design and implementation
experience.
Process Control Network design including network segregation
Process Control Systems: Virtual Infrastructure design and
implementation and ability to perform advanced troubleshooting activities
with IS.
System Integration using OPC, Foundation Fieldbus, Profibus,
and DeviceNet technologies.
Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.

• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost
estimate development, business case development, detailed design, engineering and
validation documentation and project execution.
• The ideal individual must be a self-directed team player ready to mentor and develop
engineering staff and embrace a team-based culture that relies on collaboration for
effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
Ability to perform independently, self-motivated, organized, able to multi-task in project
environments, and skilled in communication, facilitation, and collaboration.]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Tue, 07 Apr 2026 00:00:00 EDT 1
Role: Specialist Manufacturing, New Product Introduction

Lets do this! We strive to serve every patient, every time.
In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO B20 - you will be responsible for the introduction of new products into the manufacturing plant. This Specialist Manufacturing role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20.
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a clinical and commercial product mix has to the network. This role will function as a vital interface between the 5 key functions that enable the B20 plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines.
Candidates will need to demonstrate knowledge of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team.

The NPI Lead will be primarily responsible for:
• Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.

Additional Responsibilities include:
• Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
• Representing the team at plant-wide and network-wide forums, as needed.

Preferred Qualifications:
• Project Management experience
• Direct and/or indirect people management / leadership experience
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Location: Field-Based | Finland

Type: Full-Time

Build the Market. Shape the Future.
We’re looking for a bold, entrepreneurial sales professional with recent experience in transcatheter aortic valve implantation (TAVI) to lead market development in a new territory. This is a ground-floor opportunity—no legacy accounts, no hand-holding. You’ll be responsible for opening doors, crafting sales strategies, and driving adoption of our cutting-edge TAVI solutions.
What You’ll Be Doing

• Identify and engage hospitals, physicians, and decision-makers in structural heart therapy
• Deliver compelling product presentations and clinical insights to interventional cardiologists and cardiac surgeons
• Support procedures and collaborate with clinical teams to ensure confidence in product performance
• Develop territory-specific strategies to grow market share and build long-term partnerships
• Track competitive activity and provide feedback to shape commercial direction

Who We’re Looking For

• 2+ years of recent experience selling TAVI products
• Background with leading cardiovascular companies or their distributors
• Comfortable with cold starts, strategic thinking, and high-touch selling
• Fluent in local language and English; willing to travel extensively

What You’ll Gain

• Strategic ownership of a new territory
• Strong support from global and regional teams
• Competitive compensation and performance incentives
• A fast-paced, purpose-driven environment

]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Tue, 07 Apr 2026 00:00:00 EDT 1 Additional position details from the manager below:

1. Can you please confirm your top 3 skills sets required?  Validation, Technical Writing, Problem Solving
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Validation Gap Assessment, Change order creation and documentation update, Revalidation/remediation activities to close gap assessments
3. What products (if any) will this role support?  Fusion Hollow Fiber Oxygenator (HFO) and Cardiotomy Venous Reservoirs (CVR)
4. What is your target years of experience?  5-15

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Tue, 07 Apr 2026 00:00:00 EDT 1 The Opportunity:  Food & Beverage Coordinator

Seeking a highly organized and service-oriented Food & Beverage Coordinator to oversee café and break room operations across our headquarters. Reporting to the Senior Director, Food & Beverage, Events, this onsite role plays a critical part in maintaining quality, cleanliness, compliance, and overall employee experience within our food and beverage spaces.

This role requires strong operational discipline, vendor coordination, and a proactive approach to maintaining high hospitality standards aligned with RevMed’s culture.

Key Responsibilities

Café Operations Management

• 
  Oversee daily café operations, ensuring cleanliness, stocking, organization, and presentation standards are consistently met.
  
• 
  Coordinate café setup and breakdown for daily service and special events.
  
• 
  Submit and track work orders for equipment or facility-related issues.
  
• 
  Ensure proper cleaning, preventative maintenance, and operational readiness of café equipment.
  
• 
  Partner with Facilities and vendors to resolve equipment issues efficiently.
  

Break Room Management

• 
  Maintain cleanliness, organization, and labeling standards across all break rooms.
  
• 
  Oversee day porter activities to ensure consistent replenishment and upkeep.
  
• 
  Ensure food safety standards are upheld, including proper labeling and storage practices.
  
• 
  Support branding and visual consistency across café and break room spaces in alignment with company standards.
  

Vendor Management & Budget Tracking

• 
  Maintain productive working relationships with café, snack, beverage, and service vendors.
  
• 
  Monitor vendor performance to ensure service quality, cleanliness, and compliance with standards.
  
• 
  Track expenses and support reporting to ensure operations remain within approved budget parameters.
  
• 
  Identify cost efficiencies and opportunities for operational improvement.
  

EH&S Coordination & Compliance

• 
  Partner with Environmental Health & Safety (EH&S) to ensure all café and break room operations meet safety and sustainability standards.
  
• 
  Support sustainability initiatives, including waste reduction and environmentally responsible practices.
  
• 
  Ensure compliance with all health department regulations, permitting requirements, and inspection readiness.
  
• 
  Maintain documentation and coordinate renewals for required health department permits.
  

Quality Control & Employee Experience

• 
  Uphold high quality standards across food presentation, cleanliness, service levels, and operational execution.
  
• 
  Support feedback mechanisms to continuously improve food and beverage spaces.
  
• 
  Contribute to creating an inclusive, comfortable, and welcoming environment for all employees.
  

Required Skills, Experience and Education:

• 
  3+ years of experience in food & beverage operations, hospitality, or related field.
  
• 
  Strong understanding of food safety, sanitation, and health department compliance standards.
  
• 
  Experience coordinating vendors and service providers in a corporate or high-volume environment.
  
• 
  Strong organizational and systems skills with attention to detail.
  
• 
  Demonstrated ability to manage multiple priorities in a fast-paced setting.
  
• 
  Effective communication and collaboration skills across diverse stakeholder groups.
  
• 
  Proficiency in Microsoft Office Suite (Outlook, Word, Excel).
  

Preferred Skills:

• 
  Experience in a corporate, biotech, or high-growth environment.
  
• 
  Familiarity with work order systems and basic facilities coordination.
  
• 
  Bilingual (Spanish/English) a plus.
  

]]> Tue, 07 Apr 2026 00:00:00 EDT 0 Job Summary

As part of our CMS Sales Team, you will be responsible for selling our non-invasive wearable cardiac defibrillator system, and other products such as our portfolio of cardiac diagnostic services to Health Care Professionals in the hospital and out of hospital setting. This includes the initial sales call as well as support activities to promote consistent use (Local Medical Education Programs, Tradeshows, clinical symposiums and conferences). Call points include: Physicians (Cardiologists, Electrophysiologists, Hospitalists, CT Surgeons etc.), Nurse Practitioners, Physician Assistants, nurses, case managers and administrators. Other duties include selling the value of the Patient Management System (ZPM) to clinicians as well as educating HCP's and staff about the types of patients indicated for a WCD and all essential ordering and billing requirements.

Essential Functions

 

• 
  Provide customers with relevant clinical data that supports the risk of Sudden Cardiac Death in certain patient types and the role of the WCD in protecting these patients
  
• 
  Provide customers with relevant clinical, reporting, and technical information that supports the utilization of Cardiac Diagnostic products for appropriate patients.
  
• 
  Responsible for sales and supporting activities to drive consistent utilization
  
• 
  Responsible for achieving assigned sales objectives
  
• 
  Responsible for selling the value of the Patient Management (ZPM) to clinicians as well as educating HCP’s and staff about all essential ordering and billing requirements for the WCD
  
• 
  Maintain database of accounts, prepare and submit reports
  
• 
  Maintain a yearly and quarterly business plan
  
• 
  Manage field expenses and submit reports in a timely manner
  
• 
  Attend key Medical Education Programs, exhibits and conventions
  
• 
  Become a company expert and resource on both products and relevant industry trends
  
• 
  Master both Customer Centric Selling and Integrity Selling skills
  
• 
  Maintain a collaborative and professional working relationship with all business partners
  
• 
  Represent  in a professional and ethical manner. Always maintain a positive attitude
  
• 
  Communicate openly and share information with others
  
• 
  Analyze and report on trends that you observe within your territory
  
• 
  Ensure all relevant information and documentation is provided to intake and reimbursement to ensure appropriate and timely filing of billing claims
  
• 
  Maintain credentialing/access to all assigned accounts at all times
  

Required/Preferred Education and Experience

• 
  Bachelor's Degree From four-year college or university required
  
• 
  3-5 years sales experience in medical equipment sales or specialized/hospital based pharmaceutical sales or 5 years of successful sales experience, with at least one of those years in healthcare sales required
  
• 
  Cardiology experience preferred
  
• 
  Valid state driver’s license Required
  

Knowledge, Skills and Abilities

• 
  Ability to be credentialed/have access privileges in all assigned customer accounts.
  
• 
  Documented history of sales success
  
• 
  Proficient with Microsoft Office Suite
  
• 
  Must live within the assigned territory
  
• 
  Internal candidates that do not meet the sales experience criteria above may be hired if they have demonstrated a sustained ability to meet the expectations of a sales role and have been in a sales support role for a minimum of 1 year OR have successfully performed within a Associate Territory Manager role.
  

Physical Demands

• 
  This position requires the employee to sit, stand, walk, talk, listen, hear and speak on a regular basis. May occasionally be required to stoop and bend.
  
• 
  Must be able to drive an automobile and may be required to travel by train or airplane as needed.
  

Working Conditions

• 
  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  
• 
  This job is a field-based position. Employee will be responsible for working daily in hospitals, doctors’ offices and other medical establishments within the assigned territory. Occasionally may be required work atypical hours (evenings and weekends) based on business needs.
  

]]> Tue, 07 Apr 2026 00:00:00 EDT 0 Market Access & HTA-Manager

Join a Leading Healthcare Research and Consulting Organization and Make an Impact in the German Healthcare Landscape

Are you an experienced professional with a passion for market access and health technology assessment (HTA)? We are seeking a dynamic and independent Market Access & HTA-Manager to join our respected team specializing in HTA submissions within Germany. This role offers a unique opportunity to work on impactful dossiers, collaborate with international colleagues, and contribute to shaping healthcare policies. Based remotely across Germany with the flexibility to balance busy periods and quieter times, you will be at the forefront of supporting innovative healthcare solutions through meticulous HTA processes.

Required Skills

• Minimum of 2 years of experience in Market Access, specifically with a focus on HTA submissions in Germany
• Proven experience with AMNOG dossiers for HTA submissions
• Demonstrated ability to independently manage and write comprehensive dossiers
• Excellent communication skills, capable of liaising effectively with colleagues across UK, Spain, Italy, France, and clients
• Strong organizational skills and attention to detail
• Adaptability to changing workload demands and flexible work hours

Nice to Have Skills

• Experience working in healthcare policy or public health
• Multilingual abilities, particularly in German, English, or other European languages
• Prior experience in consulting or research within healthcare systems
• Knowledge of European HTA practices beyond Germany

Preferred Education and Experience

• Bachelor’s degree or higher in Life Sciences, Health Economics, Public Policy, or related fields
• At least 2+ years of direct experience in Market Access or HTA dossier preparation, with a focus on the German market

Other Requirements

• Ability to work remotely from anywhere in Germany
• Willingness to participate in interviews via MS Teams with HR, line managers, and team leads
• Flexibility to accommodate varying workloads, including occasional longer hours during busy periods
• Commitment to continuous professional development in market access and HTA knowledge

If you are driven, detail-oriented, and ready to advance your career in a leading organization shaping healthcare in Germany, we encourage you to apply and become a vital part of our innovative team.
]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Join a leading medical technology organisation and take on a key role in expanding access to innovative cardiovascular solutions across Switzerland. In this strategic and clinical sales position, you drive growth in TAVI and coronary therapies by partnering closely with hospitals, cath labs, and cardiology centres.
What You Will Do

• Manage your sales territory with a focus on TAVI and coronary product portfolios, developing existing centres and identifying new opportunities.
• Lead clinical, technical, and commercial discussions to position solutions within interventional cardiology and structural heart teams.
• Build strong relationships with physicians, nurses, technicians, procurement teams, and other decision?makers.
• Support clinical workflows in the cath lab and provide confident in?procedure product support during interventions.
• Analyse regional market potential and execute targeted sales strategies to meet defined growth objectives.
• Deliver product trainings, workshops, and educational sessions for clinical users.
• Represent the organisation at congresses, events, and professional meetings.
• Maintain clear, structured documentation in the CRM system and manage your pipeline proactively.
• Plan and coordinate travel independently across the Swiss territory.

What You Bring

• Clinical or medical?technical background, ideally with experience in cath lab, interventional cardiology, or cardiovascular therapies.
• Several years of sales experience in medical devices, preferably in complex or procedure?driven environments.
• Strong communication skills and the ability to build sustainable stakeholder relationships at all levels.
• High readiness to support clinical procedures and operate comfortably in a procedural, hands?on environment.
• Self?driven, proactive, solution?oriented working style with strong ownership.
• Excellent organisational skills and a structured, reliable approach.
• Fluent German and English; French is an advantage.
• Willingness to travel extensively within Switzerland.

Ideal Background

• 2–5 years of MedTech sales experience
• Degree in a medical, scientific, or technical field
• Passion for cardiovascular therapies and close collaboration with clinical teams

]]> Tue, 07 Apr 2026 00:00:00 EDT 1
Marketing Specialist – TAVI | Benelux
We’re supporting a leading organisation in the structural heart space in their search for an experienced Marketing Specialist to drive market?focused initiatives across the Benelux region. This is a key hire within their European expansion, ideal for a hands?on marketer with deep expertise in TAVI (Transcatheter Aortic Valve Implantation) therapies.
Role Overview
This position sits at the intersection of clinical marketing, regional strategy, and customer engagement. You’ll be responsible for localising marketing initiatives, coordinating events and conferences, and managing relationships with regional KOLs, while collaborating with global and European teams who provide extensive support across digital, content, and campaign delivery.
Key Responsibilities

• Lead the planning and execution of regional events, congress participation, workshops, and educational activities
• Manage relationships with KOLs, clinical partners, and strategic hospital stakeholders
• Adapt and localise global marketing strategies, materials, and content for the Benelux market
• Ensure brand and messaging consistency while tailoring communication to local needs
• Act as the regional marketing point of contact, collaborating closely with:
  • A large global digital marketing team supporting campaigns, materials, and social content
  • European Sales teams and clinical specialists
  • Training and education centres based in Germany and Spain
• Provide market insights to inform strategic decisions and support commercial growth

About You

• Must have proven experience working with TAVI therapies
• Strong background in medical device marketing, preferably within cardiology or structural heart
• Comfortable being the local marketing lead, capable of operating autonomously while collaborating with global teams
• Skilled in event coordination, stakeholder management, and educational program planning
• Able to translate clinical value into compelling, locally relevant marketing messaging
• Detail?oriented, proactive, and excited by a role that blends strategy with hands?on execution

What’s on Offer

• The chance to play a key role as one of the first marketing hires in Europe
• Strong backing from global, European, and training centre teams
• A highly visible role supporting a fast?growing structural heart portfolio
• Opportunity to shape local marketing across a significant and expanding region

If you’re an experienced TAVI marketing professional looking to make a meaningful impact in a growing organisation, we’d love to hear from you.
]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Must Have

Experience with multiple 3D printing technologies and materials (i.e. setting up jobs and running jobs, troubleshooting failures, post-processing parts, etc.)

High school diploma or equivalent

CAD expertise (e.g. Solidworks)

Mechanical aptitude

Demonstrated experience designing parts/assemblies/systems that provide a range of solutions and outcomes

Demonstrated ability to work and collaborate with customers of various backgrounds and needs

Demonstrated ability to work under timelines

Strong communication skills

Demonstrated ability to work well both autonomously and as a member of a cohesive team

Demonstrated high quality standards with great attention to detail

Strong desire to collaborate with others to solve problems

Strong ability to manage and prioritize time

8+ years of relevant experience

 

Nice to Have

Experience working at a medical device company

Toolmaking experience

Familiarity with the following 3D printing technologies: FDM, FFF, SLA, DLP, Polyjet, Binder Jetting, MJF, Metal

 
]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Position Summary

The QC Analyst I, reporting to the Manager of Quality Control, will be responsible for serving as a performing routine GMP testing on analytical methods in the Quality Control laboratories.

 

Job Responsibilities

· Perform routine analytical testing including but not limited to cell-based potency assays,ddPCR, qPCR, ELISAs, limit tests using HPLC techniques.

· Prepare solutions and maintain cell lines for various clinical programs

· Prepares laboratory solutions, maintains cell lines, and other day to day laboratory activities.

· Maintains laboratory documentation including logbooks, test forms, LIMS data, and electronic data.

· Assist with revisions of work instructions, SOPs, forms, reports, and electronic laboratory notebook analytical records.

· Assist with management analytical test method supplies and samples as needed.

· Ensure lab areas are clean, organized, maintain equipment and consumables.

· Work closely with Analytical Development, Quality Control, Quality Assurance, Production staff and any other relevant departments.

· Strictly adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.

· Participates in continuous improvement projects in the AD and QC labs.

· Support revisions to work instructions, SOPs, forms, protocols, and reports

 

Minimum Requirements

· Bachelor’s degree in biology or related field.
]]> Tue, 07 Apr 2026 00:00:00 EDT 1 General Summary:
This position is designed for enthusiastic, detail-oriented individuals who thrive in a fast-paced environment and are passionate about supporting families. We are seeking candidates excited to focus on assisting parents and families throughout their overall experience with our products and services.

 

The role requires a commitment to meeting key performance indicators (KPIs), adhering to outreach protocols, and delivering an exceptional customer experience. This is a great opportunity for individuals looking to build a career in the biotech sector with an organization that offers excellent training programs and growth opportunities.

Responsibilities:

• Achieve daily, weekly, and monthly goals.
• Comply with assigned schedules, assignments, and productivity metrics.
• Promptly, efficiently, and accurately contact existing customer or lead database.
• Assure the quality, integrity, and accuracy of client information.
• Master product information for accurate dissemination to customers.
• Comply with standard operating procedures and instructions within a quality management system.
• Assist customers and medical professionals throughout the birthing process and delivery lifecycle of ViaCord’s service.
• Successfully resolve customer challenges.
• Handle escalated customer issues as needed
• Build and maintain strong customer relationships.
• Promote an open communication model and a positive teamwork environment.
• Partner with Customer Service Management to assist with new-hire training, as needed.
• Participate in continuous improvement projects within the department.
• Participate in cross-functional improvement initiatives

Skills:

• Exceptional communication and organizational skills.
• Proven ability to meet and exceed KPIs and outreach protocols.
• Strong attention to detail, especially in recordkeeping and compliance.
• Previous experience in customer service, sales, or biotech preferred.
• Proficiency in CRM tools and database management.
• 2+ years of service or relevant experience preferred

Education:
Bachelor's Degree, preferred]]> Tue, 07 Apr 2026 00:00:00 EDT 1 The Quality Control Analyst I for the QC Microbiology Department will be responsible for performing processing of routine environmental monitoring samples, product-release testing, and raw material testing. The position requires the utmost attention to detail, good organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
• Receives raw materials and supplies for the QC laboratory and maintains laboratory supplies, media and reagents inventory
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Participates with maintaining proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Responsible for assisting with routine laboratory upkeep and organization
• Utilizes GMP systems such as MODA and other laboratory computer systems
• Reviews test results of other QC analysts for accuracy and precision and maintains and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform all other related duties as assigned.

QCI QUALIFICATIONS:
• Bachelor's degree in biology or relevant scientific discipline required
• Minimum 0-2 years relevant laboratory experience or experience in a cGMP and/or FDA regulated industry or a combination of education and related work experience required
• May consider less education and professional experience upon successful completion of the companies internship program
• Ability to work in Clean Room environment with full gowning requirements
• Ability to work independently or as a team member
• Detail-oriented with strong written and verbal communication skills
• Demonstrated knowledge in Microbiology and aseptic techniques
• Ability to problem-solve and troubleshoot as necessary
• Familiarity with laser particle counters, viable air samplers, microscope, Endosafe® Instrumentation, PCR, BacT/ALERT systems

QCII:
The Quality Control Analyst II for the QC Microbiology Department will be responsible for performing routine environmental monitoring, product testing, and raw material testing. The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Performs sterility testing and endotoxin testing of raw materials, in-process samples and finished products
• Performs growth promotion of microbial media
• Performs environmental monitoring, including air viable particulate, non-viable particulate and surface sampling and personnel monitoring
• Prepares environmental monitoring excursion reports and conducts minor laboratory investigations.
• Receives raw materials and supplies for the QC laboratory and maintains laboratory supplies, media and reagents inventory
• Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability
• Assists the QC Supervisor/Leads with managing proper overall operation of department (physical inventories, logs, documentation, filing, etc.)
• Maintains familiarity with QC-relevant current Good Manufacturing Practices (cGMP) guidance (CFR, USP, EP, ICH, etc.)
• Responsible for assisting with routine laboratory upkeep and organization
• Reviews test results of other QC analysts for accuracy and precision and maintains and efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
• Perform other related duties as assigned

QCII QUALIFICATIONS:
• Bachelors or higher degree in the biological sciences or related field required
• Minimum of 1-2 years relevant laboraty experience or experience in a cGMP/FDA regulated industry, or a combination of years of educated and relevant laboratory experience or experience in a cGMP/FDA regulated industry
• Demonstrated knowledge in Microbiology and aseptic techniques required
• Ability to work independently or as a team member
• Ability to work in Clean Room environment with full gowning requirements
• Ability to problem-solve and troubleshoot as necessary
• Detail-oriented with strong written and verbal communication skills
• Familiarity with laser particle counters, viable air samplers, microscope, Endosafe® Instrumentation, PCR, BacT/ALERT systems preferred
• Familiarity with laboratory data systems such as MODA, LIMS, etc preferred


Pay ranges betweem 20-24/hr based on experience ]]> Tue, 07 Apr 2026 00:00:00 EDT 1
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Tue, 07 Apr 2026 00:00:00 EDT 1 Tue, 07 Apr 2026 00:00:00 EDT 1 Tue, 07 Apr 2026 00:00:00 EDT 1
• Set up, operate equipment, and monitor production processes, including clean-in-place (CIP) and steam-in-place (SIP) operations and report production in written and electronic documents in accordance with good manufacturing practice (GMPs) and good documentation procedures (GDPs), review documentation as appropriate.
• Attain qualification for all assigned tasks and maintain individual training plan.
• Perform basic laboratory tasks, such as monitor pH, conductivity, test product samples, etc.
• Perform material movements, transfer raw materials, chemicals into, out of, across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization, support 6S programs. Must be willing to gown and work in a "clean room" environment.
Administrative tasks - attending shift exchange, meetings, sending/receiving emails, participating in projects.
• Perform other duties as assigned.

Pay ranges between 20-23.25/hr based on experience ]]> Tue, 07 Apr 2026 00:00:00 EDT 1
This position is responsible for maintaining a high quality supply of raw materials to the various departments in Gainesville in a timely and efficient manner. 

Duties & Responsibilities:

• Perform all processes in accordance with Standard Operating Procedures
• Communicates any occurrences to team leader or supervisor immediately
• Responsible for keeping areas neat and clean.  Adhere to the cleaning schedule in order to maintain a clean, safe, and bio-secure work environment.
• Maintains accurate and timely records
• Keeps all incubators, flats and carts cleaned
• Responsible for general preventative maintenance at incubation building
• Assist with opening and separating egg boxes
• Assist with racking and candling of eggs
• Assist with the delivery of eggs
• Learn all responsibilities that pertain to the processing of the raw materials (receive, rack, set, candle, and deliver)
• Unload egg truck weekly using a pallet jack.
• Learn how to operate the ACI Incubators and alarm system.
• Promote and follow all safety procedures and guidelines.
• Complete all GMP paperwork in required amount of time.
• Performs other duties as assigned.
• Will also work in sterilization team focusing on warehousing and managing waste flows to ensure lab floors are clean and stocked

 
Skills:    

• Ability to follow written SOPs consistently
• Knowledge of Microsoft Office software a plus
• Ability to separate 200 to 300 boxes (50lbs each) and lifting these boxes shoulder height for extended periods (3 to 5 hours)
• Other tasks involve twisting, turning, bending, and stooping while lifting 35 to 40 lbs (trays, pallets) for extended periods (3 to 4 hours)
• Pushing, pulling, and maneuvering heavy carts on slightly sloped surfaces
• Good visual accuracy in low light setting.
• Warehouse inventory control computerized experience preferred

Education:    

• HS diploma

Pay Rate: $20/hr]]> Mon, 06 Apr 2026 00:00:00 EDT 1
Job Details:

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.;

Skills: previous intern experience is a plus? experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.

Day to Day Responsibilities:
• Supports ongoing hands-on lab-based development in visual inspection process development (i.e. development and maintenance of defect standards and panels, establishment of GMP procedures related to operations)
• Implements and documents off-line and on-site drug product characterization studies
• Author and/or own high-quality process technology transfer and other technical documents.

Additional Job Description:
As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.

Key responsibilities include:
• Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect standards and panels, establishment of GMP procedures related to operations)
• Supports the establishment of robust tactical and strategic objectives related to visual inspection
• Implements and documents off-line and on-site drug product characterization studies
• Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
• Support one or more clinical and commercial process introductions or process transfers into manufacturing network

Preferred Qualifications
• 3+ years of experience within the pharmaceutical/biotechnology industry
• Experience in development/characterization of drug product unit operations, especially visual inspections
• Understanding of process related stresses that impact the quality and stability of biologics
• Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
• Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
• Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
• Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
• Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
• Ability to learn and act on dynamic information at a rapid pace
• Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
• Laboratory or pilot plant experience with process equipment

Basic Qualifications
• Masters degree
• Bachelors degree and 2 years of engineering and/or operations experience
• Associates degree and 4 years of engineering and/or operations experience
• High school diploma / GED and 6 years of engineering and/or operations experience]]> Mon, 06 Apr 2026 00:00:00 EDT 1 Support the planning and coordination of production and procurement to ensure a stable supply of finished and bulk products while maintaining optimal inventory levels. Work closely with internal teams and manufacturing sites to create accurate production schedules and procurement plans.
Key Responsibilities

• 
  Develop and manage production plans for finished and semi-finished products based on demand forecasts.
  
• 
  Plan procurement of raw materials, packaging, and production equipment to meet production needs and maintain appropriate inventory.
  
• 
  Coordinate with commercial, finance, and manufacturing teams to ensure accurate planning and smooth operations.
  
• 
  Support product launch schedules, including initial production and validation batches.
  
• 
  Contribute to achieving departmental KPIs and identify opportunities for productivity improvements.
  

Qualifications & Experience

• 
  Bachelor’s degree (any field) or equivalent professional experience in supply chain, production, or inventory management.
  
• 
  3+ years of experience in supply chain, logistics, or production planning. Experience in regulated manufacturing environments (GMP/GDP) is desirable.
  
• 
  Familiarity with ERP systems, production processes, and inventory management is advantageous.
  
• 
  Strong collaboration, negotiation, and communication skills.
  
• 
  Working knowledge of English is required.
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Mon, 06 Apr 2026 00:00:00 EDT 1 Key Responsibilities

Global Product Oversight
Partner with regional marketing teams to understand market needs, collect insights, and ensure consistent global messaging and positioning. Assist in coordinating product availability, demand planning, and cross regional alignment to support commercial success. Track and report global product adoption, customer usage trends, and key commercial metrics.

Product Marketing Support
Develop and update marketing collateral, product presentations, sales enablement tools, and training materials. Support campaign execution, product launches, and promotional activities across regions. Assist in conducting competitive analysis and market research to inform product strategy and positioning.

Product Lifecycle Management
Support end to end product lifecycle activities, including product introductions, updates, discontinuations, and quality/improvement initiatives. Monitor product performance, competitive activity, and customer feedback to identify enhancement opportunities and risks. Maintain product documentation, forecasts, and SKU management to ensure global accuracy and continuity.

Cross Functional Collaboration
Work closely with engineering, clinical, regulatory, and operations teams to support product updates, quality improvements, and compliance activities. Participate in field visits, customer feedback cycles, and VOC activities to deepen understanding of user needs. Support project teams with timelines, documentation, and communications to ensure aligned, on time delivery of initiatives.

Qualifications
Must Have
-Basic project coordination skills, including tracking tasks, timelines, and deliverables while managing multiple workstreams
-Comfort working with cross functional teams in a professional office environment
-Proficiency with Microsoft Office (Excel, PowerPoint, Word)
-Strong attention to detail and ability to follow procedures.
-Strong communication skills

Nice To Have
-Experience managing or routing content through internal approval systems
-Experience with collaboration or project tools
-Exposure to marketing or product lifecycle support activities
-Familiarity with regulated industries (medical devices, pharma, life sciences)
Introductory experience supporting global or regional teams

Bachelor’s degree in Marketing, Business, Engineering, Life Sciences, or related field. 1–3 years of experience in product management, marketing, or related healthcare/technology field (medical device experience preferred). Strong analytical, communication, and organizational skills. Ability to collaborate in a cross functional, fast paced environment.  Proficiency in PowerPoint, Excel, and project management tools; familiarity with medical device regulations is a plus.

Pay $35-38
]]> Mon, 06 Apr 2026 00:00:00 EDT 1 Senior Software Safety Engineer
As a Senior Software Safety Engineer, you’ll play a critical role in designing and shaping cutting-edge cardiac rhythm management products that improve patient outcomes worldwide.  Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. We are comprised of three businesses:  Cardiac Pacing Therapies, Cardiovascular Diagnostics & Services and Defibrillation Solutions.
This is your chance to collaborate with diverse, cross-functional teams—including product development, software reliability, cybersecurity, human research development, medical safety, and regulatory bodies—to ensure our products meet the highest safety and performance standards. Your expertise will directly influence the development, production, and market release of life-saving technologies.
In this exciting role, you’ll:

• 
  Identify and mitigate patient safety hazards within company software, working closely with cross functional teams.
  
• 
  Ensure risk management files are meticulously developed and maintained in compliance with ISO 13485, ISO 14971, and IEC 62304 standards, while providing critical feedback during the design input and output phases.
  
• 
  Lead efforts to trace design validation and verification in risk management files, ensuring every safety measure aligns with global standards.
  

• 
  Recommend innovative risk mitigations and deliver data-driven risk-versus-benefit analyses to project stakeholders, always keeping patient safety as the top priority.
  
• 
  Design and develop reusable patterns and encourage innovation that will increase team velocity.
  

This position is in Mounds View, MN within the Cardiac Rhythm Management (CRM) unit.   We bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
In general, the following responsibilities apply for the Senior Software Safety Engineer role. This includes, but is not limited to the following:

• 
  Collaborates with cross-functional teams to develop and release new cardiac rhythm management software products and design changes.
  
• 
  Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products.
  
• 
  Completes risk analysis studies of new design and processes. 
  
• 
  Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes. 
  
• 
  Ensures that corrective measures meet acceptable reliability standards. 
  
• 
  Analyzes preliminary plans and develops reliability/safety engineering programs to achieve company, customer and governmental agency reliability/safety objectives. 
  
• 
  Develops, coordinates and conducts technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. 
  
• 
  Recommends and develops design or test methods and statistical process control procedures for achieving required levels of product reliability and safety. 
  
• 
  Proposes changes in design or formulation to improve system and/or process reliability and product safety. 
  

Qualifications - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME

• 
  Bachelor’s degree in engineering, math, science or technical discipline and minimum of 4+ years of work experience in engineering and/or quality OR advanced degree in engineering, science or technical field with 2+ years of work experience in engineering and/or quality.
  

Nice to Have

• 
  Advanced degree in engineering or science.
  
• 
  Proven understanding of product reliability/safety engineering principles.
  
• 
  Experience in a highly regulated industry, preferably implantable medical devices. 
  
• 
  Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc. 
  
• 
  Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HAL, FTA, DFMEA). 
  
• 
  Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
  
• 
  Experience in design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
  
• 
  Working knowledge of artificial intelligence (AI) tools.
  
• 
  Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices.
  
• 
  Proficiency in two or more of the following technologies: C++, Java, JavaScript, HTML, C#, .NET, Python, Angular, Xamarin.
  

]]> Mon, 06 Apr 2026 00:00:00 EDT 1 Description:
Ensures the safety, compliance, and smooth operations of Research and Development laboratories associated with the team. Regulates and maintains the infrastructure of the labs to ensure necessary services are available to scientists. Oversees/coordinates work processes and operation of assigned laboratory areas to ensure Quality System compliance, Safety compliance, and proper equipment management. Ensures decisions involving Research and Development labs and equipment do not adversely impact work areas or project teams. Represents Lab Management team as a subject matter expert regarding lab/equipment issues, and builds professional relationships with cross-functional teams.

Responsibilities
• Coordinate, oversees, and authorizes the use of designated laboratory areas with regard to general lab operations (orientation, use, access, general supply replenishment, equipment, cleaning, & maintenance), regulatory compliance (documentation, temperature monitoring) and general safety operations.
• Enforces Safety and other required laboratory practices, with the independent authority to deny lab users room access, impose re-orientation, and contact user’s supervisor if necessary. Mediates Lab User conflicts with the authority to escalate issues to direct supervisors.
• Manages lab documentation to ensure Quality, Safety and departmental compliance. Reviews and ensures equipment/instrumentation documentation (log sheets, chart recorders) is compliant with Good Documentation Practices. Resolves documentation issues with equipment users.
• Acts and serves as point of contact with department scientific staff and cross-functionally with Subject Matter Experts in Calibration/Facilities to ensure minimal impact to Development project teams during installation, calibration and validation of new non-Roche branded equipment.
• Coordinates calibration, certification, relocation and repair of existing equipment with Instrument /Facilities/Calibration team to minimize impact on project teams needing access to equipment.
• Serves as a resource and subject matter expert to scientific staff regarding media preparation.
• Participates in the on-call services for CTU excursion
• Other duties as assigned by management.

Qualifications
Lab Supervisor experience
Bachelor's Degree- Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work-experience.

Pay ranges between $35-41/hr based on experience 
]]> Mon, 06 Apr 2026 00:00:00 EDT 1 Duties:

• Assigned most complex cases while operating the inventory management and control systems, to receive, supply, transfer, take inventory, record cycle counts and store materials and/or products while maintaining accurate inventories both physically and systemically. Prepare expired and/or obsolete inventory for destruction.
• Applies expertise in the process of receiving and inspecting raw materials, packaging materials, semi-finished and finished products from suppliers, purchase orders or production orders and/or transfers using inventory control and management systems and mechanical equipment such as forklifts, order pickers, electric and manual pallet jacks, etc., as well as auxiliary materials for the operation.
• Performs highly accurate real-time data entry SAP to receive inventory items and capture inventory related transactions; ensure adherence to First Expiry–First Out (FEFO) policy, expired materials receive proper attention, and requesting departments are properly debited for materials as directed by supervisor.
• Identify by affixing labels, all the materials and products received, perform the proper packaging of each pallet, box or shipping vessel or container, and perform the delivery of materials to the corresponding warehouse. Service Quality requirements for sampling (request for materials to be sampled). Serves as a resource for more junior technicians.
• Authority over ordering support materials such as additional materials including, but not limited to, labels, packing materials, etc.
• Prepares and transfers products or materials shipment to production, export, external warehouse, etc. from approved inventories to local or intercompany available cost centers or storage locations, including logging and preparing required documentation including signatures, following GDP's with the highest efficiency levels.
• Trains and mentors other technicians so they learn all aspects of their position and the workings of the warehouses and overall campus (via predetermined plan).
• Act as the key user principal or backup for GBS, addressing new demands, tests and new releases from the current template.
• Leads investigations on inventory variances, cycle inventory discrepancies, CAPA's, observations and Go Track activities from internal and external assessments or audits.
• Expertly and effectively prioritizes tasks, makes sound decisions, and takes ownership of projects from start to finish. On a limited basis seeks guidance and clarification when needed from the department supervisor, manager or group lead on tasks, issues, and/or situations of significant complexity that may be challenging to navigate independently.
• Keeps the work area (all warehouse locations, coolers, freezers) clean and tidy (everything in place) at all times. Stay trained and current in quality systems (LOS).

Skills:

• Required Experience SAP, Cycle Counts, Standup and Sit-down forklift.
• Requires extensive knowledge in SAP relevant to the job, including but not limited to material inventory queries, bin to bin transfers, TO and TR orders and basic data entry adjustments to warehouse inventory.
• Learn and employ the 5S system of Lean Manufacturing.
• Certified to operate all forklifts, both stand up and sit down, order pickers, electric pallet jacks, manual pallet jacks.
• Intermediate experience leading/managing a team.
• Strong communication skills needed to respond to internal quality check and audit findings, to carry out day-to-day customer service and train less junior staff.
• Knowledge of mechanical equipment including forklift certification.
• Advanced knowledge of SAP, WCS or similar ERP storage system.
• Advanced Microsoft Office Suite (MS Word, Excel, Outlook).
• Ability to use GoTrack for investigations and deviations.
• Skilled in operating electric and manual pallet jacks, forklifts and other order picking equipment with forklift certification.
• Organized with attention to detail and a teamwork mindset.
• Ability to train others.
• Advanced 5S knowledge preferred.
• Inventory counting skills.
• Problem solving skills.
• Ability to lift fifty pounds unaided.
• Green belt desirable.
• Ability to work at least one weekend per month on an "On Call" basis.
• Ability to give guidance and clarity when needed to junior technician.
• Ability to lead/manage/motivate a team.

Education:

• High School diploma or GED, Associates Degree preferred.
• Six or more years warehouse or relevant manufacturing/production/material handling experience.

Pay Rate: $30/hr]]> Mon, 06 Apr 2026 00:00:00 EDT 1 *depending on experience

Position Overview
Associate Scientist II is primarily responsible for testing samples, drafting methods and reporting
data under cGMP regulatory guidance for Large Molecules/Biologics product development and
related stability studies.
In support of Large Molecules/Biologics Therapeutics, will execute laboratory testing using the
following techniques as required:
? Compendial assays, (i.e., appearance. pH, Osmolality, Particulate measurements, Viscosity
etc.)
? Karl Fischer
? UV-Vis
? HPLC/UPLC techniques/methods (e.g., SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis,
etc.)
? Aggregation techniques such as MFI, AUC, SEC-MALS
? Capillary and Gel Electrophoresis (e.g., CE-SDS, SDS-PAGE, icIEF, IEF, western blot, etc.)
? FTIR, CD, Intrinsic Fluorescence, DSC
? Other technologies/methodologies as required by management

II. Essential Functions
? Reads and follows Standard Operating procedures with attention to details
? Successfully trains on 1-2 methods and/or techniques mentioned above and performs adhoc
sample testing activities under cGMP as required
? Applies basic scientific and laboratory concepts and theories related to specific testing in the
group
? Follow cGMP requirements for legible, accurate and thorough documentation to meet
regulatory compliance. Supports drafting of simple methods, method forms and result reports.
? Adheres to policies, processes, and procedures for operating laboratory equipment in a safe
and compliant manner
? Understands the Catalent culture, programs, and communication processes regarding quality,
safety, and ethical practices
? All other duties as assigned

III. Position Requirements
Education and Experience:
? Bachelor’s Degree in Life Sciences or Physical Science field. No work experience required
2
Knowledge/Skills Requirements:
? Has basic knowledge of the principles and concepts of a discipline (e.g., Biology, Chemistry,
Biochemistry).
? Excellent written and verbal communications skills with internal customers, colleagues, and
supervisor
? Well organized with ability to multitask and be flexible with daily work schedule
? Ability to work effectively under pressure to meet deadlines
? Ability to pay attention to detail and exhibit critical thinking]]> Mon, 06 Apr 2026 00:00:00 EDT 1 *depending on experience

Position Overview
Associate Scientist II under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.

II. Essential Functions
• Labeling, organizing and tracking the flow of documents, including spreadsheets, reports, protocols etc.
• Authors documents, such as stability protocols, text reports, certificates of analysis, and operating procedures
• Performs parallel review of documentation and may become qualified to perform technical review of documents for accuracy, thoroughness and regulatory compliance.
• Develop and execute stability work plans/schedules independently, using customer milestones and Division/site performance standards and metrics.
• Review technical documents for accuracy, thoroughness and regulatory compliance
• Identifies opportunities for improvement projects.
• Perform activities under cGMP as appropriate.
• All other duties as assigned.

III. Position Requirements
Education and Experience:
• Bachelor’s Degree in Life Sciences or Physical Science field. No work experience required,

Knowledge/Skills Requirements:
• High Proficiency in Microsoft Office, Word, Excel, Outlook
• Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
• Ability to learn and retain technical information.
• Proactively address work issues at both an individual level and a team level.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Mathematical and scientific reasoning ability.
• Excellent written and verbal communications skills with internal and external customers.
• Lead by example according to Catalent's values and culture.
• Strategy is focused on personal time management and efficiency.
• Well organized with ability to multitask.
• Ability to work effectively under pressure to meet deadlines.]]> Mon, 06 Apr 2026 00:00:00 EDT 1 Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions: • Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, always ensuring patient safety comes first.
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
Knowledge, Skills and Abilities: • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment





  Pay Rate Range: $20 - $29.08  ]]> Fri, 03 Apr 2026 00:00:00 EDT 1 Key Responsibilities:

• Execute tissue processing to prepare high-quality samples for analysis, ensuring consistency and adherence to established protocols.
• Conduct tissue embedding using paraffin and frozen section techniques to enable accurate sectioning and downstream applications.
• Perform tissue staining, including immunohistochemistry (IHC), immunofluorescence (IF), and histological staining, to support imaging and research goals.
• Troubleshoot and optimize protocols to ensure reproducible, high-quality results.
• Collaborate with researchers to design experiments, analyze data, and interpret findings.
• Maintain detailed records of procedures, results, and inventory in compliance with laboratory standards.

Skills:    
Required Qualifications and Skills:

• Experience: 3-5 years of hands-on experience in tissue processing, tissue staining, and tissue embedding in a research or clinical laboratory setting.
• Technical Skills:
• Proficiency in histological techniques, including paraffin and cryosectioning.
• Expertise in IHC, IF, and other histological staining methods.
• Ability to troubleshoot and optimize tissue preparation protocols.
• Analytical Skills: Strong attention to detail and ability to analyze and interpret experimental data.
• Organizational Skills: Excellent time-management and multitasking abilities to handle multiple projects efficiently.
• Communication Skills: Clear written and verbal communication for collaborating with researchers and documenting procedures.
• Teamwork: Ability to work both independently and collaboratively in a team-oriented research environment.
• Compliance: Familiarity with laboratory safety protocols and quality control standards.

Education:

• Master’s degree in biology, biomedical sciences, or a related field (bachelor’s degree with significant relevant experience may be considered).

Pay Rate Range: $30-41/hr ]]> Fri, 03 Apr 2026 00:00:00 EDT 1
The Opportunity:

• Proactively manage and maintain business partners complex calendars and meetings
• Coordinate and manage complex travel needs and logistics
• Plan large mid-level, internal meetings (e.g. department meeting, large team/committee)
• Possess advanced knowledge of Genentech IT systems (ex: cSuite, virtual collaboration tools, etc.)
• Manage relationships with internal and external stakeholders, often with a high level of confidentiality required
• Create contracts/purchase orders, and process payment and expense reports.
• Help coordinate candidate/interview process
• Manage and plan team building events & workshops ( depending on role and level)
• Independently lead the planning & execution of complex team offsites (involving multiple locations, days, activities, and/or travel needs)
• Draft email communications on behalf of manager, team, department, leader, etc
• Manage departmental gSites, Slack, websites, newsletters, etc. (collect content, distribute information, oversee maintenance)
• Project Management support: Quality Compliance & Clinical Capabilities (QC3) projects & initiatives
• Additional responsibilities assigned (based on business need)

Who You Are:

• Ability to multitask, prioritize and execute tasks independently. May assist in the coordination of work flow among team members
• Collaborative, initiates and facilitates team development, ensures all relevant or useful information within the team is shared, works with different functions to achieve the best overall outcome
• Ability to handle and exercise judgment and discretion concerning sensitive, confidential and proprietary information
• Demonstrates accuracy and attention to detail of own and other's work, communicates and ensures standards for accuracy and detail within the team
• Based on breadth of experience, skill and strategic context, makes decisions independently and with minimal need of external input/validation
• Experience working with senior leaders/management
• In depth knowledge of Microsoft Office (Power Point, Excel and Word), cSuite Tools (including gMail, gCal, gSheets, gSlides, Trello, Jamboard, gMeet, ZOOM) and able to provide instruction or training to others as needed
• An average of 5-7 years related administrative, operations or project management experience (experience gained in pharmaceutical / biotechnology industry is preferred.)
• BS/BA degree or equivalent industry experience

Pay Rate Range: $25-32/hr depending on experience ]]> Fri, 03 Apr 2026 00:00:00 EDT 1

Join the Immunology & Respiratory Department’s Discovery Sciences Team to identify and develop transformational drugs for immune-mediated diseases.

As in vitro scientist, you will work closely with the project leader and in vitro lead to develop, validate, and execute assays to modulate lymphocytes.

Work closely in a matrix global team to meet project achievements, with the goal to deliver therapies that transform the lives of patients.

 As in vitro scientist on projects, you will design and execute in vitro assays for target validation, compound profiling and hit validations.

 Work closely with project lead and in vitro lead to deliver high quality assays.

Interact with other scientists in the group to share assay protocols and seek feedback on assay design and troubleshooting.

Maintain accurate and reliable records including electronic notebooks and all other pertinent documentation.

Present data at project team meetings and group meetings Skills:    

• Prior experience working in pharma or equivalent industry is not required but will be considered a plus.
• Prior experience with establishing and validating in vitro assays for lymphocyte functions and modulations (B and T cells) is desired.
• Experience in gene knockdown, CRISPR, validation is desired but not necessary
• Experience in immune phenotyping and functional assays, including multicolor flow cytometry (10+ colors), ICS, ELISpot, proliferation assays, and cytokine ELISA/MSD.
• Analyzing data using biological and statistical software such as Prism, FlowJo, OMIQ, Excel, etc.

Education:    

• Master’s degree from an accredited institution with one-plus (4+) years of experience in a related scientific discipline (Biology, Immunology, Cell biology) OR Bachelor’s degree from an accredited institution with seven-plus (7+) years of experience in a STEM discipline.

Pay Rate Range: $40-51/hr depending on experience ]]> Fri, 03 Apr 2026 00:00:00 EDT 1 The Analytical Operations (AO) department is seeking an enthusiastic and motivated Research Associate to be part of our analytical testing team. This role utilizes analytical tools to characterize the physical and chemical properties of biopharmaceutical products. This work is essential for supporting both process development and validation, and for determining product quality, purity, and stability.

About Analytical Operations (AO)
Analytical Operations (AO) is a non-GMP department within the PTDA Analytical Development Quality Control organization, dedicated to advancing the company's R&D pipeline. The department is focused on providing technical expertise and analytical support for early-stage research, development, and process validation for departments across the South San Francisco campus as well as other internal sites. This support is delivered through high-throughput testing, automation, effective data management, and robust business processes, all of which facilitate timely and scientifically informed decisions.

Key Responsibilities

• Conduct routine and non-routine analytical testing using a variety of physiochemical techniques (U/HPLC, icIEF, CE-SDS, and LC-MS), according to established protocols.
• Maintain accurate, detailed documentation of assays and data results in an Electronic Laboratory Notebook (ELN), strictly adhering to ALCOA+ principles.
• Perform essential lab support tasks, including stocking consumables, checking for expired reagents and hazardous waste, and de-icing freezers.
• Comply with laboratory best practices, safety guidelines, and internal and regulatory standards.

Job Requirements

• Bachelors degree with a minimum of 3 years of relevant experience, or a Masters degree with laboratory experience in Chemistry, Biochemistry, or a related scientific field. Experience in the biotech or pharmaceutical industry is preferred.
• Must be highly organized, detail-oriented, and self-motivated, with a proven ability to successfully manage multiple tasks, both independently and collaboratively as part of a team
• Hands-on experience with HPLC/UPLC, CE, or LC-MS is required.
• Strong written and verbal communication skills are a must, with the ability to present technical work clearly.
• Knowledge of GMP compliance, experience with ELN, and intermediate proficiency in Microsoft Excel is highly desirable.
• Ability to lift 20 lbs. for laboratory-related tasks.

Pay Rate Range: $20-26/hr depending on experience ]]> Fri, 03 Apr 2026 00:00:00 EDT 1 Description:

Summary:
A typical Research Assistant performs a variety of administrative tasks in support of clinical trials and assists in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies.

Responsibilities

• Verify and/or correct research study information on source documents. Research queries and variances, and provide feedback to the site data collector
• Input research study data into trial Electronic Data Capture (EDC) system, maintaining quality control for content, accuracy, and completeness
• Prepare and maintain research study files
• Compile, collate and submit study information within established deadlines
• Assist in maintenance of regulatory documentation
• Schedule subject visits and generate appropriate reports and documents for research subjects prior to visits
• Input visit data into Clinical Trial Management System (CTMS) to track patient visits and procedures completed against the study budget
• Processing of required lab specimens, labeling of vials, and accurately filling out requisitions for storage and/or shipment per the study protocol and packaging and shipment regulations
• Perform various administrative support functions such as reception, office organization, and office supply management

Skills

• Basic knowledge of clinical trials
• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• Basic knowledge of medical terminology
• Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
• Excellent interpersonal skills

Education/Experience: 

• BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting; e.g. clinical research coordinator, nurse, medical assistant

Pay Rate Range: $30-38/hr depending on experience 
]]> Fri, 03 Apr 2026 00:00:00 EDT 1 We are looking for a seasoned Enterprise Architect to join our team on a contract-to-hire basis. Your goal is to bridge the gap between complex current-state limitations and a streamlined, scalable target state that enables our business and IT partners to thrive. You’ll have a seat at the table for the most "impactful" use cases on our roadmap.

Key Responsibilities & Deliverables
Architecture Strategy & Point of View (PoV) Development
Current State Assessment: Deep dive into existing architectures to identify bottlenecks, technical debt, and scalability limitations.
Option Appraisal: Evaluate multiple architectural alternatives, providing a clear-eyed analysis of pros, cons, costs, risks & impact for each by keeping an unbiased & vendor neutral approach.
Target State Definition: Define robust target state architectures and create Architecture Point of Views (POVs) for high priority use cases in Data, AI, Cloud, Integrations and Collaboration platforms
Standardization: Develop and document architecture best practices, standards and Reference Architectures for common, repeatable use cases to ensure consistency across the enterprise.
Governance & The ARB
ARB Leadership: Present PoVs and architectural designs to the Architecture Review Board (ARB), defending technical choices while remaining open to collaborative refinement.
Process Improvement: Act as a key contributor to the evolution of our EA governance process, making it more agile, effective & non-disruptive.
Finalization: Work closely with the ARB to finalize and formalize all architectural artifacts.
Stakeholder Collaboration & Socialization
Cross-Functional Partnership: Act as the "connective tissue" between Data, Analytics, AI, and Enterprise Integration functions.
Partner Enablement: Socialize finalized standards and best practices with the application / data / solution teams & external consulting partners to ensure high-quality delivery.
Business Alignment: Translate complex technical roadmaps into business value for non-technical stakeholders.

Skills:    
Experience: 15+ years in IT, with at least 5+ years in an Enterprise Architecture role and 5+ years in a Solution / Application / Data Architecture role preferably within the Life Sciences, Med Tech or Healthcare sector

Technical Breadth: Proven experience in Cloud (GCP / AWS), Data Lake & Warehouses (Snowflake), AI/ML (Predictive AI, Generative AI, Agentic AI), Integrations (APIs, Pub-Sub, Streams, File Transfers)

Industry Domain: Prior experience in the Biopharma / Life Sciences industry is recommended or nice-to-have

Domain Knowledge: Familiarity with Life Sciences capabilities, functions (R&D, Drug Development or Clinical, Regulatory, Pharmacovigilance, Manufacturing, Medical Affairs, Commercial), and common GxP / regulated use cases

Education:    
Education: Bachelor’s or master’s degree in Enterprise Architecture, Computer Science, Information Technology, Information Management or a related discipline
Frameworks / Certifications: Certified or strong familiarity with TOGAF, Zachman Ontology Framework or similar EA framework or methodologies (but with a practical, non-dogmatic application mindset)

Minimum Degree Required:  Bachelor's Degree

Pay Range: $70-78/hr *based on experience ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Position Overview

 

The Senior Calibration Technician, reporting to the Manager, Laboratory Operations, will be responsible for independently managing laboratory equipment calibrations, maintenance, and repairs in coordination with external vendors and laboratory staff at our RTP locations.

 

Responsibilities

· Independently plans, schedules, and performs maintenance, calibration, and repairs on active equipment utilizing the Computerized Maintenance Management System (CMMS).

· Oversees and manages onsite vendors to ensure all training and compliance requirements are met for maintenance, calibration, and repairs on laboratory equipment.

· Reviews and approves equipment calibration and maintenance documentation performed by external vendors with a detailed eye for good documentation practices.

· Initiates, writes, and assists with investigations related to instrument calibration failures or other instrument related issues.

· Induction of new equipment including development of calibration requirements and schedules in coordination with equipment owners.

· Research the operating specifications of new equipment, obtain suitable standards, and establish the calibration acceptance criteria.

· Conducts thermal mapping studies for controlled environments to validate and optimize equipment performance.

· Maintains and/or generates SOPs or other controlled documents pertaining to operation, maintenance, and calibration of laboratory instrumentation and equipment.

· Reviews system documentation, including user requirement documents and specification documents for instrumentation.

· Interfaces with multi-disciplinary teams regarding laboratory equipment including, lab staff, Quality Assurance, Computer Systems Validation, Facilities and Engineering, and IT.

· Contacts and obtains technical information from vendors or service providers.

· Thoroughly documents all activities and reviews all data to ensure completeness and accuracy within the CMMS.

· Adheres to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.

· Ensures all calibration and thermal mapping activities comply with relevant industry regulations (e.g., USP, NIST, FDA, GLP, GMP).

 

Minimum Requirements

· High School Diploma and 9+ years of metrology experience OR Bachelor’s Degree and 5+ years of metrology experience is required.

· Experience working in the Pharma/Biotech industry.

· Understanding of calibration methodology and tolerances.

· Experience working with loop calibrations.

· Understanding of FDA and GxP regulations and requirements.

· Experience working in GMP, GLP environments.

· Experience investigating and completing CAPAs and deviations.

· Ability to read and interpret instrument technical drawings.

· Working knowledge and understanding of laboratory analytical instrumentation and small-scale manufacturing equipment.

· Ability to work independently in a fast-paced, highly interactive environment with excellent self-organization skills.

· Excellent verbal and written communication skills.

· Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.

 

Preferred Requirements

· Bachelor’s Degree in a relevant field

· Certified Calibration Technician

· Experience working in CLIA, and R&D laboratory environments
]]> Thu, 02 Apr 2026 00:00:00 EDT 1 We’re supporting a high?growth interventional cardiology organisation in the search for a Coronary Area Sales Manager to drive commercial expansion across NSW. This is a hands?on role for someone with proven coronary intervention experience who wants ownership, momentum, and the chance to build a territory from the ground up.
The Role
You’ll lead commercial activity across Sydney and wider NSW, developing relationships with interventional cardiologists, cath lab teams, and key hospital stakeholders. Expect a mix of case support, clinical education, and proactive business development as you grow the coronary portfolio in a competitive market.
What You’ll Be Doing

• Accelerating adoption of a premium coronary intervention portfolio across NSW.
• Providing in?lab product expertise, supporting procedures, and ensuring high?quality clinical engagement.
• Opening new accounts through targeted outreach, consistent follow?up, and strategic territory planning.
• Identifying growth opportunities and executing plans to increase market share.
• Acting as the key clinical and commercial representative for the brand in the region.

What You Bring

• 2+ years of recent coronary intervention sales experience — essential.
• Background with major coronary systems or their distributors.
• Up to 10 years total experience — suited to someone in the growth phase of their career, adaptable and hungry.
• A proactive, tenacious mindset — comfortable with building a market, knocking on doors, and developing strategy.
• Strong relationship?building skills and credibility in procedural environments.
• Based in Sydney with flexibility to travel across broader NSW.

Why This Role

• High?impact position with the opportunity to shape a major territory.
• Strong autonomy and visibility within a fast?growing business.
• Competitive package and career progression in a top?performing therapy area.

If you’re ready to take ownership and build something meaningful in coronary intervention, this role gives you the platform to do it.
]]> Thu, 02 Apr 2026 00:00:00 EDT 1

We’re partnering with a global organisation to hire a VAT & Intrastat Accountant who will support high?quality financial operations across the region. This role sits within a modern GBS finance environment and plays a key part in ensuring accurate, timely, and compliant VAT and Intrastat activities.
The Opportunity
You’ll execute key accounting processes, ensure compliant VAT and Intrastat reporting, support month?end activities, and contribute to continuous improvement projects. You’ll collaborate with regional teams, uphold strong internal controls, and help drive efficiency across finance operations.

---

What You’ll Do VAT & Intrastat Execution

• Manage day?to?day VAT and Intrastat tasks, ensuring quality, efficiency, and timely completion.
• Deliver accurate declarations and payments, meeting all local legal and compliance requirements.
• Complete internal and external reporting aligned with regulatory standards.

Financial Controls & Compliance

• Maintain full adherence to internal controls and SOX requirements.
• Follow up on audit or SOX action items to strengthen process integrity.
• Safeguard the completeness and accuracy of financial data and accounting entries.

Month-End Accounting

• Execute assigned month?end activities within defined timelines.
• Support completeness and correctness checks across VAT and Intrastat processes.

Performance & SLA Management

• Ensure SLA commitments are met for accuracy, timeliness, and reporting quality.
• Support performance metrics related to declaration timeliness and correctness.

Process Improvement

• Identify opportunities for standardisation and optimisation within VAT and Intrastat activities.
• Discuss improvement ideas with management and implement agreed changes.
• Participate in projects aimed at enhancing process efficiency and compliance.

---

About You

• Bachelor’s degree in Accountancy with strong affinity for VAT.
• Experience in VAT declarations, Intrastat reporting, month?end, and SOX controls.
• Strong Excel skills; SAP knowledge is a plus.
• Fluent in English; additional European languages are an advantage.
• Highly organised planner with strong attention to detail.
• Proven experience in accountancy and proactive problem?solving mindset.

]]> Thu, 02 Apr 2026 00:00:00 EDT 1
This position reports into the Packaging Engineering group under Combination Product Operations (CPO) in Ohio (AOH). The position will support global supply, new product introductions, partnerships/acquisitions and combination products. This position utilizes physics, engineering and chemistry principles coupled with advanced and diverse materials science understanding and principles to assist in the evaluation, design, qualification and implementation of packaging components and the associated systems such as documentation, equipment and processes. A knowledge of common materials utilized in pharmaceutical packaging is key to this role. This role will support manufacturing network by applying broad knowledge of pharmaceutical packaging operations, equipment, devices, and materials to develop the industry’s best combination product assembly and packaging processes. Understanding of packaging manufacturing equipment and processes and how materials interact with these is essential to the position. The job will require both planning and technical support of complex projects supporting a new site start-up. This role will be responsible for planning and overseeing projects to ensure on-time completion, establish priorities, report project status updates, and manage project dashboards for the Secondary Packaging Engineering team. This role will have some entry level management potential and the successful candidate will also utilize excellent organizational, project management, technical problem solving and communication (written and verbal) skills, with the ability to work in teams and adapt to a rapidly changing environment. This role requires management, problem solving, communication (written and verbal), and organizational skills, and the ability to work in teams and adapt to rapidly changing environment. Project Management experience supporting implementation of commercial packaging configurations is preferred. Candidate must possess extensive knowledge and expertise in the use of project management methodologies and tools.


This position is responsible and accountable for the following:
• Project Management of entry level engineers and contingent workers
• Evaluation, recommendation and selection of new secondary packaging materials for pharmaceutical products
• Assessing complex problems relating to materials, recommending and implementing solutions
• Write test protocols, perform technical evaluations and submitting technical assessment reports to justify the use of selected materials
• Write Technical Specifications
• Representing Final Product Technologies as required
• Technology transfer from clinical to commercial or from site to site for packaging components and equipment processes
• Establish priorities to ensure all projects are managed within expected due dates
• Lead and present new packaging ideas, concepts and design ideas to the Product Development team
• Ensures cGMP and regulatory compliance are met
• Ensures that change control procedures are followed working with QA and Regulatory to implement changes
• Participants in Pre-Approval Inspections (PAI) and interact with regulatory bodies (e.g., FDA, EMEA, etc.) as needed
• Collaborates with cross-functional teams (i.e. Research, QA/QC, Supply Chain, Maintenance, Manufacturing, Regulatory, etc.) in pre-commercial and commercial activities

Basic Qualifications:
• Doctorate degree in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field
OR
• Master’s degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 5 years of Packaging Engineering experience
OR
• Bachelor’s degree in in Packaging Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, or related engineering field & 8 years of Packaging Engineering experience

Preferred Qualifications:
• Master’s degree in Packaging Engineering, Materials Science, Pharmacology, Mechanical Engineering, Chemical Engineering, or related engineering field
• 7+ years of packaging engineering experience with 4+ years within the Pharma/Bio industry

Demonstrated Competencies/Skills:
• Leading technical teams
• Independent thinker with demonstrated skills working in teams or leading technical project teams
• Strong Interpersonal and communication skills
• Project management
• Ability to manage competing priorities]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Clinical Supply Chain Logistics Manager – Moreton

Are you a seasoned logistics professional with a passion for clinical trials? Join our dynamic team as a Clinical Supply Chain Logistics Manager based in Moreton, where you'll play a pivotal role in ensuring the seamless delivery of Investigational Medicinal Products (IMPs) to support critical clinical research milestones. This highly visible position offers the opportunity to oversee end-to-end logistics operations during hyper-care phases, coordinating with global partners and internal teams to maintain supply continuity and operational excellence. If you're ready to make a tangible impact in the healthcare industry and thrive in a fast-paced, team-oriented environment, we want to hear from you!

Required Skills:

• Bachelor's degree in Supply Chain, Life Sciences, Engineering, or a related field
• Proven experience in clinical supply chain logistics operations, ideally within a global clinical trial setting
• Hands-on experience managing Stock Transfer Orders (STOs), shipments, and issue resolution
• Ability to operate effectively under high-pressure, time-sensitive conditions during hyper-care phases
• Exceptional communication skills to liaise across study teams, regional leads, external partners, and vendors
• Strong organizational skills with meticulous attention to detail and multitasking abilities
• Experience working with external logistics partners such as CMOs, depots, and logistics providers

Nice to Have Skills:

• Experience managing temperature-sensitive or patient-critical shipments
• Familiarity with external depots and international supply networks
• Knowledge of compliance and regulatory requirements in clinical trial logistics
• Prior experience in coordinating in similar depots
• Proficiency in report generation and risk mitigation planning

Preferred Education and Experience:

• Bachelor's degree or equivalent qualification in relevant fields
• Minimum of 3-5 years’ experience in clinical or pharmaceutical supply chain logistics
• Demonstrated success in managing complex logistics during high-stakes clinical trial phases

Take this opportunity to elevate your career in clinical supply chain management and contribute to groundbreaking medical research. Apply now and become a vital part of a collaborative team dedicated to getting life-changing treatments to patients on time!
]]> Thu, 02 Apr 2026 00:00:00 EDT 1
AP Email Inbox
•       Wholly owns AP inbox and reviews each email thoroughly
•       Respond to all general inquiries and only delegate emails to the respective analyst if:
•       The email is a response in a thread between the sender and analyst
•       The email is a complex inquiry that requires a higher-level response

Mitigate Escalations
•       Review each email and alert the appropriate team member should it appear that it's moving in the direction of escalation. If something is clearly escalating, alert Sr. Manager for visibility.
•       If an email is unable to be answered in a timely fashion, an acknowledgement will be provided to the sender to assure them that their email is being addressed, but there may be a delay due to (insert brief description of reason).

Physical Mail
•       Scan invoices to processing team
•       Review statements to determine whether necessary to distribute to respective analyst or not
•       Reach out to suppliers sending physical mail and request that invoices/statements solely be emailed to AP to reduce duplicate efforts and waste consumption

A/P Floater
•       Backup to analysts when they are out of the office.

Financial Disclosures & Escheats Audits
•       Support per Regulatory team requests; review findings with Sr. AP Manager upon completion
•       Escheats audit fulfillment; align with tax team if/when request is received

Invoice Entries
•       Refunds, credit/debit notes, disbursement requests, tax payments, etc. as instructed by AP Sr. Associate

 ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Pay 38-42/hr depending on experience

Duties
• End-to-end contract management, including receiving and submitting, monitoring and tracking a large volume of contracts from draft through final signatures
• Monitoring and tracking a large volume of requisition requests from submission to financial approval and PO creation
• Creating and submitting contract and financial requisition requests using SAP/Ariba (contracting & procurement platform) and Coupa/Spend Source (spend management tool)
• Researching vendors in systems to determine if vendors are active, prior to contracting new relationships; handle new supplier submissions or updating existing suppliers as necessary
• Drafting and routing multiple contract types for review/negotiation: Non-Disclosure Agreements, Scopes of Work, and Change Orders
• Acting as a liaison between the company, internal business partners, and outside vendors to facilitate contract execution
• Building and maintaining relationships with internal business partners
• Engaging with other functional areas within the company to assess and respond to contracting and requisition needs, obligations, and revisions
• Monitoring and coordinating complex workflows between the business, Procurement, Finance and Legal Departments to ensure tasks move forward in a timely manner

Skills
• Prior experience in contract management required
• Strong acumen for SAP/Ariba and Coupa/Spend Source platforms
• Comfortability with ambiguity and navigating complex processes and systems
• Ability to work autonomously and proactively, capable of troubleshooting and figuring things out
• Detail-oriented: strong proofreading and editing skills
• Strong computer skills in database management and document preparation (Word, PowerPoint, Excel)
• Ability to manage heavy workload and aggressive timelines in a timely manner, prioritize, and work under pressure
• Strong written and verbal communication skills
• Customer service oriented: must be able to communicate effectively with internal business partners as well as external vendors/suppliers
Preferred:
• Experience in contracts administration or other relevant experience is strongly preferred.
• Experience at a large law firm or within an in-house legal department of a public company a plus.
• Experience within biotech/pharma/medical device industry or other contract-intensive fields a plus.
• Familiarity with SpringCM is a plus.
• Science background is a plus

Education
• Prior experience]]> Thu, 02 Apr 2026 00:00:00 EDT 1
Job Summary:
The role of the Research Technician is to serve as an integral member of the site and study team during study processes, including pre-admit, admission, orientation, conduct, discharge and study close.

Essential Functions:
• Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Operating Procedures (SOP's), QA/QC procedures, OSH guidelines and other state and local regulations as applicable
• Provides assistance in the execution of clinical trials
• Ensures the well-being and safety of study participants
• Provides administrative and operational support

Qualifications:
• Education A high school diploma or G.E.D. and
Phlebotomist certification is required.

Experience:
• One to two (1-2) years of experience in a clinical environment
• An equivalent combination of education and experience may be accepted as a
satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure N/A
• Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to
perform the essential functions of the job)
• Able to obtain vital signs and perform ECGs
• Able to perform telemetry and insertion of intravenous catheters, or a willingness to learn
• Excellent oral, written and interpersonal communication skills
• Able to work independently and handle multiple competing priorities
• Able to work with tight deadlines
• Able to function independently within a team environment
• Excellent organizational and time-management skills and a strong attention to detail
Proficient in MS Office Suite (Word, Excel, Outlook)
Other N/A

Physical Requirements and Working Conditions:
• Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, and lifting materials and supplies weighing up to 50 pounds.

Physical Demands:
• Bending and leaning up to 4 hours - changing position approximately every 2 minutes

• Variable hours including nights and weekends

Work Environment:
• Predominantly clinical conduct environment
Non-supervisory, non-managerial]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Pay 40-50/h depending on experience

HM's Top Needs:

1. Medical device regulatory experience in change assessment with focus on US FDA and EU MDR

2. Experience with medical device manufacturing process changes and design changes

3. Experience with US (510k, LTF, Deciding when to submit…) and EU (change notifications with Notified Bodies)

 

Education Required: Bachelors

Years’ Experience Required: 3-5 years

 

Will the contractor be working 40 hours a week? If not, weekly estimate?  Yes, 40 hours

Work Location:

                Do they need to be local to any MDT office and if so where? Yes, MA, CT, CO, MN… other MDT sites considered

Does this person need to be on site? If so, full time or part time?  Yes, full time



Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.


 ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Join Our Team as an Outbound Sales Specialist – North Netherlands

Are you a dynamic sales professional with a passion for building lasting relationships? Do you thrive in a fast-paced environment where your efforts directly influence growth and success? We’re looking for an ambitious Outbound Sales Specialist to join our growing team and help expand our presence in North Netherlands. This is your opportunity to leverage your sales expertise, connect with veterinary clinics, and make a real impact in the animal health industry.

In this role, you will be responsible for engaging with veterinary clinics primarily through outbound calls and virtual meetings, nurturing existing leads, and converting follow-up opportunities into long-term partnerships. Your proactive approach will help us strengthen our European footprint by creating new opportunities, maintaining excellent client relationships, and supporting our ambitious growth targets. If you’re a hunter with a consultative mindset and a love for sales, you’ll thrive here.

Required Skills:

• 3-5 years of outbound sales experience, preferably within veterinary, health, or medical-related sectors
• Proven track record of achieving sales targets and developing new business
• Excellent negotiation, communication, and relationship-building skills
• Strong self-motivation and resilience in a target-driven environment
• Fluency in Dutch and English, with good command of relevant medical/industry terminology
• Ability to lead conversations and position solutions effectively over the phone and via video calls
• Knowledge of CRM systems and pipeline management tools
• Strong organizational and time-management skills

Nice to Have Skills:

• Experience in the veterinary market or clinical/medical sales
• Familiarity with industry competitors, market trends, and veterinary sector dynamics
• Experience working with cross-border or European markets
• Certification or training in veterinary or medical sales (beneficial but not mandatory)

Preferred Education and Experience:

• Relevant tertiary education or equivalent experience
• 3-5 years successful outbound sales experience within a b2b environment
• Previous experience in veterinary or health-related sales is highly advantageous, but transferable skills in other health sectors are also valued

Other Requirements:

• Local language fluency in Dutch; proficiency in English
• Willingness to travel regionally within North Netherlands for client meetings or events, if needed
• A proactive, hunter mentality with a passion for sales and relationship building
• Ability to adapt and learn quickly in a specialized industry

If you’re excited to join a forward-thinking company that values passion, persistence, and professionalism, we want to hear from you. Elevate your career by helping veterinary clinics thrive and grow with our innovative products—apply now and be part of our success story!
]]> Thu, 02 Apr 2026 00:00:00 EDT 1 • Build out and/or update a form and workflow to handle our international travel requests. A table will also need to be built to track the number of days a user is traveling internationally per year.
• Proven hands-on experience with ServiceNow Flow Designer (required)
• Strong proficiency in JavaScript development within the ServiceNow platform
• Demonstrated experience utilizing GlideQuery and GlideRecord APIs
• Extensive experience designing and building custom ServiceNow tables and data models
• ServiceNow System Administrator Certification
• Developing, configuring, and customizing the ServiceNow platform to fit business requirements.
• Collaborating with cross-functional teams to identify and prioritize business requirements
• Writing clean, efficient, and maintainable code requires expertise to achieve.
• Code reviews and quality control checks should be undertaken as part of every project to guarantee maximum efficiency and productivity.
• Debugging and fixing technical problems
• Producing and running test cases to guarantee software quality.
• Documenting code and application functionality

Skills:    
Preferred Qualifications:
ServiceNow Flow Designer Micro?Certification
Experience utilizing REST/SOAP APIs and integrations
Proven problem-solving and analytical abilities
Excellent communication and collaboration skills
Capability to work both independently and collaboratively
Prior contract or consulting experience

Education: NA

Pay ranges between 110-134/hr based on experience ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Senior Research Associate – Formulation & Analytical Support

Position Summary
We are seeking a highly skilled Senior Research Associate to provide formulation and analytical support for oligonucleotide based therapeutics across in vitro and in vivo studies. This individual will work both independently and collaboratively to ensure high quality dosing solutions, execute stability testing, support analytical workflows, and contribute to nonclinical and clinical development programs.

Key Responsibilities
Formulation & Dosing Support
• Independently and collaboratively prepare, formulate, and quality check dosing solutions for a range of in vitro and in vivo studies
• Perform formulation stability studies and define appropriate short and long term storage conditions
• Support formulation strategies for oligonucleotides across different delivery and study paradigms

Analytical & Technical Support
• Execute analytical assays to support formulation and quality assessment, including UV, LC MS, and osmolality measurements
• Perform quantitative data analysis across multiple experiments, including basic statistical and graphical analysis
• Proactively troubleshoot technical issues and recommend corrective actions to ensure data quality and project continuity

Innovation & Capability Building
• Develop new techniques or introduce new technologies to enhance the group’s formulation and analytical capabilities
• Contribute to continuous improvement of laboratory workflows and experimental approaches

Documentation & Communication
• Maintain accurate and thorough laboratory notebook records in compliance with data integrity standards
• Prepare SOPs, technical reports, and documentation to support nonclinical and clinical programs, including regulatory submissions
• Present data and actively participate in group meetings, department meetings, and Early Development team meetings

Laboratory Operations
• Share responsibility for laboratory management duties, including equipment readiness, inventory, and general lab organization

Required Skills & Experience
• Good understanding of oligonucleotide therapeutics, formulation approaches, and stability testing
• Hands on experience with analytical techniques such as UV spectroscopy, LC MS, and osmolality measurements
• Ability to perform quantitative analysis across studies with minimal supervision
• Demonstrated ability to work independently while contributing effectively within cross functional teams
• Strong problem solving skills and attention to detail

Education & Qualifications
• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field with 6+ years of relevant experience, or
• Master’s degree with 4+ years of relevant experience]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Position Summary
The Revenue Contractor will be responsible for performing all aspects of revenue management including analyzing and reporting proprietary product sales transactions with a focus on gross-to-net (GTN) accounting accuracy and compliance. The role will involve significant data analysis, collaboration with cross-functional teams, and preparation of detailed financial reports to drive optimal revenue generation, inform executive decision-making, and support revenue forecasting. The role will also be responsible for successful onboarding, integration, and ongoing management of 3PL partnerships, ensuring seamless data flow and operational alignment. The ideal candidate has strong financial management skills, a deep understanding of the life sciences market, and experience with complex regulatory environments.

Essential Functions and Responsibilities

• Analyze and report revenue transactions including proprietary product sales, rebates, chargebacks, and returns
• Perform monthly payments related to Managed Care, Medicaid, Tricare, and CGDO/MDP invoices based on invoice details from third-party provider
• Review commercial contracts with wholesalers and distributors to assess revenue implications
• Calculate and analyze GTN reserve accounts based on financial data collected from various sources, proposing corresponding adjustments and providing explanations for variances to budget
• Review third-party provider reconciliation reports and GTN model for forecasting
• Prepare GTN month-end preliminary results presentation that includes overview of reserve performances, key adjustments, and concerns to share with Commercial and FP&A
• Lead onboarding, integration, and ongoing management of the third-party logistics (3PL) partnerships
• Lead revenue-related journal entries, reconciliations, and variance analyses during month-end close
• Perform AR aging reconciliation process and clear aging return debit memo issues, working directly with 3PL personnel and customers
• Review collections data and credit profiles, providing monthly updates to the Commercial team
• Oversee certain government payments, partnering directly with government contacts and Accounts Payable to coordinate, execute, and optimize the payment process
• Assist with external audits and internal reviews by providing documentation and analysis as requested
• Maintain and enhance internal controls over revenue accounting processes
• Prepare various schedules to facilitate financial statement reports, budgeting/forecasting, and tax return preparation
• Support system implementations as they relate to GTN accounting and AR transactions through 3PLs
• Other duties as assigned

Education, Experience, Knowledge, Skills, and Abilities

• Minimum four-year college-level accounting degree, CPA or CMA preferred
• Eight or more years of experience in GTN accounting, preferably in the pharmaceutical, healthcare, or life sciences industry
• Experience with 3PLs is preferred
• An equivalent combination of experience and education may be considered
• Strong understanding of pharmaceutical pricing, reimbursement, and regulatory frameworks
• Strong financial management and analytical skills
• Solid problem-solving capabilities
• Ability to work both autonomously and cross-functionally with others
• Takes initiative and is solutions-oriented
• Experience with general office information systems, Microsoft Office products, and accounting software or ERP systems
• Advanced Microsoft Excel skills (Pivot tables, V-lookups, etc.)

Pay Rate Range: $75-$100/hr depending on experience 
]]> Thu, 02 Apr 2026 00:00:00 EDT 1
Executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures.

This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing area.  Support with troubleshooting to equipment.

Duties & Responsibilities:

• Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine.  This assistance includes tasks such as gathering tools, machine parts and documents required for such activities. Retrieves components and equipment from storage
• Assists with the equipment changeover
• Assists with minor equipment repairs/adjustments
• Assists with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues
• Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
• Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements
• Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes logbooks, as required.
• Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
• Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations
• Movement of product and components within the assembly and packaging area
• Transfer product, components and equipment within the CNC area.
• Communication and hand-off to relief personnel during shift change as appropriate
• Maintains production areas according to predefined standards (5s)
• Adheres to safety standards, identifies unsafe situation / habit and escalates appropriately

Skills
Skill Requirements:

• Basic reading, writing and understanding of English
• Read and follow Standard Operating Procedures (SOP)
• Basic math calculations (addition, subtraction, multiplication, division)
• Perform documentation according to Good Documentation Practices (GDP)
• Basic computer skills - write & send e-mail communications, utilize Microsoft office programs (Outlook, Internet Explore/Edge)

Education Requirements:

• High School degree plus minimum one (1) year work experience in GMP regulated industry
• Associate/Bachelor degree from an accredited institution or biotechnology vocational training preferred 

Pay Rate: $20/hr 

 ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Are you passionate about advancing your career in a dynamic manufacturing environment? We’re seeking a highly motivated and detail-oriented Production Technician to join our team. This pivotal role offers the opportunity to contribute to innovative projects within a reputable organization, ensuring operational excellence and quality standards are met consistently.

As a Production Technician, you will play a critical part in supporting manufacturing processes, troubleshooting equipment, and maintaining high standards of safety and efficiency. Your expertise will help drive the success of our production line and contribute to the delivery of top-tier products.

Required Skills:

• Proven experience in a technical or manufacturing environment
• Strong understanding of production processes and equipment operation
• Excellent problem-solving and troubleshooting skills
• Ability to read technical drawings and documentation
• Attention to detail and commitment to quality
• Good communication and teamwork abilities
• Familiarity with health and safety regulations in a manufacturing setting

Nice to Have Skills:

• Experience with automation or robotics
• Knowledge of lean manufacturing principles
• Certification in relevant technical or health & safety training
• Previous experience working with veterinary or pharmaceutical products

Preferred Education and Experience:

• Relevant technical qualification (e.g., NVQ, BTEC, or equivalent) in manufacturing, engineering, or a related field
• Minimum of 2 years’ experience in a similar production technician role

If you’re ready to bring your skills to a thriving team and make a real impact, we invite you to apply now and take the next step in your career!
]]> Thu, 02 Apr 2026 00:00:00 EDT 1 The Desktop Support Specialist role provides hands-on, second-level technical support for end users in the offices located in Franksville, Wisconsin and Sturtevant, Wisconsin. This role is a critical part of the onsite IT presence, ensuring reliable technology services and a positive end-user experience for the Wisconsin offices.
Job Functions and Responsibilities •    Provide onsite Level 2 support for desktops, laptops, peripherals, telephony, mobile devices, and collaboration technologies, including advanced troubleshooting and issue resolution.
•    Perform installation, imaging, configuration, and deployment of end-user hardware and software, including Windows and Apple-based devices.
•    Act as the onsite escalation point for unresolved L1 incidents, ensuring timely resolution and clear communication.
•    Support new hire onboarding and employee offboarding activities, including device provisioning, account setup coordination, training, asset recovery, and secure data handling.
•    Deliver white-glove, executive-level IT support for local leadership and visiting executives, including rapid response and proactive issue prevention.
•    Manage assigned incidents, service requests, and tasks within the ITSM platform, meeting or exceeding defined SLAs and customer satisfaction targets.
•    Participate in Priority 1 (major) incident response, assisting with issue triage, onsite coordination, root cause analysis, and post-incident follow-up.
•    Provide onsite support for conference rooms, training rooms, and AV systems, including Microsoft Teams Rooms and other collaboration technologies.
•    Coordinate with global and regional IT teams (L1, L3, infrastructure, security, and vendors) to resolve cross-functional issues.
•    Maintain accurate documentation of incidents, solutions, asset inventory, and standard operating procedures.
•    Ensure compliance with company Information Security policies, device standards, and data protection requirements.
•    Support local IT projects, office moves, technology refreshes, and site initiatives as required.
•    Participate in on-call or after-hours support rotations as needed to support business continuity.
•    Perform additional duties assigned by IT Service Delivery leadership. Job Requirements and Qualifications •    2–4 years of progressively responsible experience in desktop support, onsite IT support, or service desk environments.
•    Demonstrated experience providing onsite Level 2 support and acting as an escalation point for complex technical issues.
•    Experience supporting executive or VIP users in a professional services or corporate environment preferred.
•    Strong working knowledge of: o    Windows 10 and Windows 11
o    Microsoft 365 applications and services
o    Active Directory and user/device management
o    Mobile device platforms (iOS and iPadOS)
o    Collaboration and AV solutions (Microsoft Teams, Teams Rooms, Webex, or similar) •    Hands-on experience with ITSM ticketing systems and incident/problem/change processes.
•    Excellent customer service mindset with strong verbal and written communication skills.
•    Ability to prioritize work, manage multiple issues simultaneously, and balance urgency with sound judgment.
•    Strong attention to detail and commitment to documentation and process adherence.
•    Ability to work independently onsite while collaborating effectively with remote teams.
•    High school diploma or equivalent required.
•    Bachelor's degree in information technology, Computer Science, or a related field preferred. Work Environment •    Onsite role based in the Sturtevant, Wisconsin office; travel to the Franksville, Wisconsin office as required.
•    Frequent interaction with end users, local leadership, and visiting executives.
•    Occasional lifting and movement of IT equipment (laptops, monitors, peripherals).
•    May require occasional after-hours or weekend support during critical incidents or planned activities.





 
Pay Rate Range: $20-23/hr depending on experience  ]]> Thu, 02 Apr 2026 00:00:00 EDT 1 Will lead the financial planning and analytics for the company and is instrumental in establishing and driving financial processes. A forward thinker that understands the strategic directions of Finance Leadership and anticipate implications/impacts.

RESPONSIBILITIES:
Manage FP&A to lead financial planning and analytics for the company
Key business partner to organization leaders to build financial forecasts communicate key business drivers and insights, variances to plan, opportunities and risks, and recommendations
Work closely with executive leadership to build long range budget plan Assist with the financial modeling for strategic initiatives, collaborations, and/or partnerships
Coordinates with all levels of management and the business to gather, analyze, summarize, and prepare recommendations on business process and policies.
Oversee and contribute to the preparation of periodical reporting packages, including financial and operating reviews, market analysis and benchmarking
Develop analytical tools to inform financial forecasts and measure financial performance
Lead ad hoc projects to identify opportunities and implement solutions for continuous process improvement
Provide ad-hoc analyses to support decision making within the business
Consolidate financial results during Budget, forecast, quarter-and year-end close cycles and facilitate earnings/guidance preparation by collaborating closely with cross-functional teams
Establish strong relationships within the company to deliver actionable results 

Requirements: 
Bachelor's degree in accounting or equivalent
Minimum of 7 years of progressive finance, accounting, and/or financial planning and analysis experience
Experience in early-stage life science companies
Data driven with strong analytical and critical thinking skill
Ability to manage highly confidential material in an appropriate manner
Excellent verbal and written communication skills, with ability to articulate financial results
Self-directed and able to work well and communicate effectively in a team environment. Hands on and able to work with minimal supervision. Ability to balance multiple deadlines and deliverables.
Exceptional interpersonal soft skills and ability to establish strong rapport and partnerships at all levels of the organization
Experienced user with knowledge of ERP, BI and automated planning systems
Proficiency in Microsoft Project
Previous experience developing financial operating policies and procedures Advanced level of proficiency with Excel, with strong financial modeling skills ]]> Wed, 01 Apr 2026 00:00:00 EDT 0 This role is a member of the GVP QA team providing Quality oversight of company's global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations. This includes support for the development and execution of the GVP audit program as well as contributing to the company's Inspection activities.
This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams.
Summary of Key Responsibilities:
Senior Manager, PV QA supports all the GVP QA’s responsibilities as listed below. Different members of the team will have particular focus areas. Senior Manager will lead specific activities:
• Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents.
• Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP)
• Support cross GxP QA activities requiring PV and PMS expertise.
• Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
• Determine, evaluate and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
• Effectively communicate and escalate critical matters to management.
• Support the Global Strategic Audit Program - contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.
• Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
• Develop and maintain processes and tools to support quality audit execution and outcomes.
• Support PV / post-marketing surveillance inspection readiness and inspection management activities.
• Provide Quality oversight of PV, PMS and PV-related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
• Develop and report GVP QA metrics and dashboards to support quality oversight.

Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs. 
• Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions. 
• Other assignments as directed. 
Requirements and skills 
• Educated to university degree (preferably life sciences) or equivalent qualification or experience 
• Extensive experience in the pharmaceutical industry in a quality or compliance function. 
• Audit skills and experience of conducting GVP audits is preferred. 
• Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH. 
• Experience supporting Health Agency inspections. 
• Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement. 
• Strong interpersonal, verbal, and written communication skills. Builds positive and productive working relationships. 
• Diplomatic in addressing sensitive issues confidentially and professionally. Works professionally with confidential information. 
• Ability to analyze complex situations / issues. Demonstrates strategic thinking 
 ]]> Wed, 01 Apr 2026 00:00:00 EDT 1

We are seeking a Specialist Physician who is committed to high standards of patient care and interested in contributing to the long term management of individuals with kidney disease. This role involves working with patients at every stage of their renal condition, from early chronic kidney disease to advanced renal failure, with a strong focus on accurate assessment, personalised treatment planning and continuous clinical support.

In Torun you will be part of a dedicated multidisciplinary team that includes nursing, dietetics, psychology and technical professionals. Together you will ensure that patients understand their condition, receive clear guidance on their therapy options and are supported in maintaining stability and quality of life. Your position will include planning diagnostic processes, communicating results, guiding patients through renal replacement therapy, and preparing them for dialysis or transplantation when required.

The role also involves taking responsibility in moments when clinical leadership is needed and contributing to research or clinical development initiatives carried out within the centre. Patient education, lifestyle counselling and long term follow up are core elements of the day to day work.

To be successful you should hold a completed specialisation in Internal Medicine or Nephrology along with a valid licence to practise. Strong communication skills, empathy and a collaborative working style are essential. Flexibility to participate in shift based work is required, with schedules arranged individually.
]]> Wed, 01 Apr 2026 00:00:00 EDT 1
Key Responsibilities:
In this dynamic role, you will organize Technology Transfer activities for Final Drug Product (FDP) manufacturing.
Responsibilities include supporting and creating project schedules, lead site assessment and manufacturing capabilities, update project dashboards, and leading team meetings to progress the project towards final objectives. You will work across a global, cross-functional team consisting of manufacturing, device and packaging design for combination products, capital projects, physical test methods, quality, and regulatory team members.
Your role will focus on leading effective Tech Transfer projects for combination products, enhancing end-to-end controls with robust methods and data flow in a GMP setting.

Supporting New Product Introduction to manufacturing site.
Owning documentation such as Project Plan, supporting engineering with Process Transfer Documents (PTD), protocols, and reports.
Supporting engineers with Make-a-Batch (M-a-B) activities to ensure sending/receiving site expectations are met.
Developing, tracking, and providing project dashboard updates.
Providing good communication plans to cross-functional teams and Process Engineer management.
Ability to apply project management and engineering science to production.
Strong teamwork and excellent interpersonal and communication skills.

Basic Qualifications:

Master’s degree
OR Bachelor’s degree and 2 years of experience
OR Associate’s degree and 6 years of experience
OR High school diploma/GED and 8 years of experience

Preferred Experience:
Experience in the Tech Transfer of Combination Product field, focusing on project management and/or manufacturing.
Understanding of interdependencies of complex projects, especially involving new product introductions with new equipment/processes.
Knowledge of Combination Product design controls and regulatory requirements on a global scale.
Familiarity with commercialization framework.
Program and Project Management skills (experience with MS Project, Smartsheet, and other project scheduling software is desired).

Additional Skills:
Proactive risk assessment, management, and mitigation.
Ability to lead and succeed in an ambiguous environment.
Strong project management skills.]]> Wed, 01 Apr 2026 00:00:00 EDT 1 Join Our Team as a Country Sales Manager – Netherlands

Are you a driven sales leader with a passion for veterinary healthcare? Do you thrive on building lasting relationships and uncovering new growth opportunities? We’re seeking an enthusiastic and strategic-minded Country Sales Manager to spearhead our expansion in the Netherlands. This is a fantastic opportunity to lead regional sales initiatives for a reputable, innovative company committed to delivering high-quality animal health products across Europe. If you’re ready to make a meaningful impact in a dynamic environment, we want to hear from you!

What You’ll Do:

• Lead and develop the Netherlands sales operations, working closely with the UK-based sales team to execute regional strategies.
• Build strong, trusted relationships with veterinary clinics, hospitals, and key stakeholders.
• Identify and capitalize on new sales opportunities, enhancing market penetration and revenue.
• Support and implement local sales tactics aligning with company goals and insights from the broader European market.
• Provide regular performance updates and collaborate with senior leadership to refine strategic direction.
• Re-engage underperforming accounts and develop a robust sales pipeline to ensure continuous growth.
• Represent the company at regional events and foster partnerships that align with our values and objectives.

What Skills You Bring:

• 10-15 years of successful veterinary or medical sales experience with a proven track record of exceeding targets.
• Leadership experience in managing or guiding sales teams, with a strategic yet hands-on approach.
• Outstanding interpersonal and negotiation skills, coupled with a proactive, can-do attitude.
• Customer-centric mindset, capable of building partnerships and understanding client needs deeply.
• Strong organizational skills with the ability to manage multiple accounts and priorities efficiently.
• Fluent in Dutch and English, with excellent communication skills.

Nice to Have:

• Previous experience selling veterinary or animal health products.
• Knowledge of the Dutch veterinary sector and market dynamics.
• Familiarity with CRM systems and digital sales tools.
• Experience working within a fast-paced, high-growth environment.

Preferred Education & Experience:

• Bachelor’s degree in Business, Veterinary Science, or a related field.
• Extensive sales background with a focus on strategic growth and account management.
• Demonstrated success in the Netherlands or broader European markets.

Additional Requirements:

• Willingness to travel regionally within the Netherlands.
• A passion for animal health and a genuine interest in improving veterinary services.
• Ability to work independently and as part of a collaborative team.

Ready to take your sales career to the next level and lead our efforts in the Netherlands? Apply now and become a vital part of a forward-thinking company dedicated to excellence in animal healthcare. Your expertise can help shape the future of veterinary sales across Europe!
]]> Tue, 31 Mar 2026 00:00:00 EDT 1
• Lead initiative to update Supply Chain (Planning and Warehouse) Standard Operating Procedures (SOPs) for the upcoming upgrade from SAP ECC to SAP S4 Hanna.
• Support User Acceptance Test and Training material for SAP S4 Hana upgrade.
• Own and provide input and support for quality systems records (deviations, change control records, CAPA, CAPA EV, SOP, etc.) or other records
• Ensure compliance with GMP/GDP and EHSS requirements
• Act as Supply Chain representative in cross departmental projects, such as S4 Hana upgrade
• Track performance on S4 Hana project KPIs and participate in network meetings
• Support measurement of Supply Chain Key Performance metrics and drive continuous improvement leveraging standard tools and methods
• Respond effectively to crises and resolve conflicts arising from competing objectives, limited resources, or differing perspectives.
• Perform root cause analysis and implement corrective actions related to associated deviations.
• Build cross-functional relationships to develop and garner support for shared programs.
• Influence a broad spectrum of partners toward achieving business goals.
• Support AOH Supply Chain continues improvements initiatives, e.g. stabilizing detail schedule, optimizing inventory levels, reducing material receipt/release lead times, improving materials movements between warehouses, etc.]]> Tue, 31 Mar 2026 00:00:00 EDT 1 SUMMARY/JOB PURPOSE:

This company is seeking a Sourcing Contract Manager to join the Pharmaceutical Operations and Supply Chain (PSC) Contracts team, reporting to the lead for Contracts & Budgets & Outsourcing.  You will be responsible for supporting the team in contract management activities such as administering, writing and execution of the contracts related to PSC team. Where required, this role will be required to support and assist in escalations and resolution of payments that have been committed to a supplier. You will support and collaborate with various internal and external business teams to address contracts and financial requests.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

• Write/draft Statement of Works (SoWs) and Change Orders (COs) associated with low-risk contracts leveraging the Agiloft Legal Contract Lifecycle Management (CLM) system.
• Advise and troubleshoot on existing agreements under the guidance of the assigned team member.
• Attend cross functional internal and external supplier meetings to ensure supplier contract terms and conditions are adequately addressed and contracts executed in a timely manner.
• Responsible for the routing, tracking and facilitating the timely progress of contracts from point of submission into PSC through to execution.
• Responsible for the creation of purchase requisitions to enable the PSC business to commence work with the scope of the executed contract.
• Where required assist and support continuous improvement activities to improve the team’s ability to deliver value to the business.
• Facilitate and support budget forecasting and accrual activities where required.
• Provide support during any financial audits at month or quarterly close, as needed.
• As applicable per designated PSC business, maintain GxP and financial audit inspection readiness.

 

SUPERVISORY RESPONSIBILITIES:

None

 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and 3 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

 

Experience/The ideal for Successful Entry into the Job:

• The ideal candidate must have 1-2 years of direct working experiences in the life-sciences industries emphasis on contract drafting and sourcing negotiations with preferably outsource services such as contract manufacturers (CMOs), and/or clinical research testing laboratories.
• Collaboration with multi-functional teams.
• Working knowledge of clinical and commercial supply chain contract terms and conditions.
• Experience in negotiating and drafting complex contract manufacturing, biologics and clinical and commercial supply chain related agreements.
• Experience in SAP, Ariba, Tableau and management of both clinical and commercial supply chain, required.
• Experience in Contract Life Management (preferred Agiloft) system.

 

Knowledge/Skills:

• Some understanding of the contract management process, including tracking, negotiation, approval and signature processes.
• Working knowledge of the drug discovery and development process and ability to understand risks and requirements associated with pharmaceutical contracting preferred.

• Ability to work effectively across a variety of functional groups such as Commercial, Research and Development, Chemistry Manufacturing Controls (CMC), Clinical Studies and Finance,) and all levels of management.

• Ability to work with vendors and effectively negotiated commercial terms.
• Flexible and willing to learn new procedures and skill sets.
• Must be detail oriented and have strong organizational skills.
• Ability to handle multiple tasks simultaneously.
• Ability to prioritize; must be responsible and conscientious.
• Ability to work under pressure to meet specific deadlines.
• Dedication to quality and reliability in all work tasks.
• Excellent verbal and written communications skills.
• Must embrace the company core values: Be Exceptional, Excel for Patients, and Exceed Together.

]]> Tue, 31 Mar 2026 00:00:00 EDT 1 We are seeking an engineer to support the reliability and performance of manufacturing equipment and facility utilities within a regulated production environment. This role focuses on maintenance strategy, calibration activities, equipment lifecycle management, and continuous improvement of operational systems.

You will work closely with production, quality, and engineering teams to ensure equipment operates safely, efficiently, and in compliance with industry standards.
Key Responsibilities
Equipment Reliability & Maintenance

• 
  Provide technical support for maintenance, calibration, and troubleshooting of manufacturing and packaging equipment and utilities.
  
• 
  Support preventive and operator-led maintenance programs to improve equipment reliability.
  
• 
  Assist in managing equipment lifecycle and spare parts strategies.
  

Engineering Improvements

• 
  Evaluate and implement technical improvements or new technologies to enhance equipment performance and productivity.
  
• 
  Participate in engineering projects related to equipment upgrades and system improvements.
  

Quality & Compliance

• 
  Ensure engineering activities align with regulatory and internal quality standards.
  
• 
  Support equipment qualification, validation, and change management processes.
  

Safety & Sustainability

• 
  Promote safe working practices and environmental responsibility.
  
• 
  Identify opportunities to improve energy efficiency and reduce operational waste.
  

Qualifications
Education
Bachelor’s degree in Engineering (Mechanical, Electrical, Mechatronics, Industrial or related discipline).

Experience

• 
  At least 2 years of experience in maintenance, calibration, or equipment reliability.
  
• 
  Experience in regulated manufacturing environments is advantageous.
  

Skills

• 
  Maintenance and equipment reliability engineering
  
• 
  Problem-solving and technical troubleshooting
  
• 
  Strong collaboration and communication skills
  
• 
  Continuous improvement mindset
  

Languages

• 
  Japanese: Professional proficiency
  
• 
  English: Beneficial in a global environment
  

About the Company
A global research-driven pharmaceutical organization focused on developing and manufacturing innovative medicines for human and animal health.
]]> Tue, 31 Mar 2026 00:00:00 EDT 1
• Assist with pre- and post-payroll auditing/reconciling procedures and troubleshoot anomalies.
• Generate and distribute standard and ad hoc payroll reports as required for partner teams.
• Process Daily Department Mail
• Assist with completing employment verifications
• Assist with collection and record keeping of overpayments
• Assist with Historical Correction data entry for time tracking
• Unemployment management
• Occupational Statistics reporting
• Assist with Monthly Tax & Garnishment Reconciliation and
• Assist with Payroll Accrual reporting
• Monitor and respond to inquiries sent to the shared Payroll inbox and partner ticketing management system

Education and/or Experience
• General Payroll-related experience
• Strong organization skills
• Microsoft Office
• Prior HCM system navigational knowledge
• Workday knowledge preferred but not required
 ]]> Tue, 31 Mar 2026 00:00:00 EDT 1 Exciting Opportunity: Statistical Director – Drive Innovation in Oncology Clinical Development

Join a pioneering team at the forefront of oncology research and development as a Statistical Director. This strategic leadership role offers the chance to influence the future of cancer treatments through expert statistical guidance and collaboration in a dynamic, global pharmaceutical environment. You will oversee complex statistical initiatives, work with cross-functional teams, and contribute to regulatory submissions, all while maintaining a flexible, home-based work arrangement in the UK with minimal in-office commitments.

What You Will Do:

• Provide expert statistical support across multiple oncology projects, including Phase I-III trials, biomarker analyses, and regulatory submissions.
• Lead complex study activities, offering strategic input on study design, analysis plans, and methodology, including Bayesian frameworks and survival analysis.
• Collaborate with study teams, medical affairs, and biomarker groups to ensure high-quality, consistent statistical deliverables.
• Represent statistical perspectives in meetings with regulatory authorities and key external stakeholders.
• Contribute to the development and validation of innovative statistical methodologies and train junior statisticians.
• Support the preparation of dossiers, publications, and presentations, translating complex data into actionable insights.

Required Skills:

• PhD or MSc in Biostatistics, Statistics, or related scientific discipline.
• Minimum 6 years (PhD) or 9+ years (MSc) of relevant industry experience, with a strong background in oncology drug development.
• Expertise in advanced statistical methods, including survival analysis and Bayesian approaches.
• Proficiency in SAS; R knowledge is a plus.
• Demonstrated experience supporting regulatory submissions and interacting with regulatory agencies.
• Strong strategic thinking, communication skills, and ability to work independently within cross-functional teams.
• Familiarity with data management processes and international work environments.

Nice to Have Skills:

• Experience with PK/PD analyses and biomarker strategies.
• Background in observational studies and clinical research beyond oncology.
• Prior involvement in early-phase (Phase I/II) clinical trials.
• Membership in professional statistical organizations and external collaborations with academic institutions.

Preferred Education and Experience:

• A PhD or MSc in a relevant scientific field, complemented by substantial industry experience.
• Proven track record of delivering impactful statistical leadership in a pharmaceutical or biotech setting.
• Experience working on highly complex methodologies and innovative research projects.

Other Requirements:

• Willingness to travel as needed for project meetings and stakeholder engagements.
• Based in the UK, with flexibility for one day per quarter in-office meetings.

If you are a strategic thinker with a passion for advancing oncology therapies through cutting-edge statistical science, we invite you to make a meaningful impact with us. Take the next step in your leadership career and apply now to be part of a global organization shaping the future of medicine.
]]> Tue, 31 Mar 2026 00:00:00 EDT 1
Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.

Key Responsibilities:
• Ensure successful product lifecycle management, from early human use through commercial submission
• Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
• Provide scientific rationale for product attributes and pre-clinical test results
• Provide product and procedural expertise for new product development as well as introduction training for clinical and site personnel
• Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.
• Ensure procedural, medical and scientific factors are considered during cross-functional product development project team meetings.
• Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports
• Consult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.
• Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.
• Analyze data to support clinical trial safety investigations and new product development
• Other duties as assigned by leadership

Education and Experience:
Bachelor's Degree in biology or lifesciences field, 5 Years years experience Class II and III medical device technologies and/or clinical studies background Required
Bachelor's Degree in engineering Preferred

Additional Skills:
• Proven expertise with computer skills - Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
• Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with pre-clinical testing protocols, hospital environments and sterile techniques
• Data analysis skills, with understanding of statistical analysis techniques
• Good communication and organizational skills
• Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
• Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
• Demonstrated problem-solving and critical thinking skills
• Thorough, conscientious and results oriented working style
• Team oriented
• Ability to work in a dynamic work environment
• Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
• Experience in TMVR and/or fluroscopic and echocardiographic imaging preferred]]> Tue, 31 Mar 2026 00:00:00 EDT 1 Job Title: Project Scheduler
Location: Japan

Position Summary
The Project Scheduler is responsible for preparing and maintaining both high-level and detailed CPM schedules across design, procurement, construction, commissioning, and integrated Design-Build / EPCM projects.
Using industry-standard scheduling tools (e.g., Primavera P6 or Microsoft Project), this role develops KPIs, tracks progress, and provides regular reporting to project teams and leadership. The position ensures that scheduling practices align with internal standards and contractual obligations.
This role may be performed remotely, with travel required based on project needs.

Key Responsibilities

• Develop CPM schedules across a range of project types, including complex Design-Build and EPCM projects
• Facilitate interactive planning sessions and Last Planner System (LPS) activities
• Collaborate with project teams to develop WBS structures, define key milestones, and establish KPIs
• Perform quality reviews of vendor and trade partner schedules and integrate them into master schedules
• Create customized schedule reports tailored to project requirements
• Update schedules, evaluate performance, identify variances, and support mitigation planning
• Conduct detailed critical path, float path, and schedule delay analyses
• Provide objective reporting on schedule health, risks, and opportunities to leadership
• Ensure scheduling practices align with company standards and contractual requirements
• Mentor and develop junior scheduling professionals to strengthen scheduling capabilities

Minimum Qualifications

• Bachelor’s degree in Construction, Engineering, or a related field
• Minimum 10 years of industry experience, including at least 5 years in a dedicated scheduling role
• Expert-level proficiency in Primavera P6 and Microsoft Project

Preferred Qualifications

• Ability to independently develop preliminary schedules with minimal project team input
• Experience supporting large-scale capital projects (multi-phase design through commissioning)
• Experience facilitating pull-planning and LPS planning sessions
• Experience mentoring and leading junior scheduling staff
• Strong verbal, written, and graphical communication skills

]]> Tue, 31 Mar 2026 00:00:00 EDT 1 Job description:

The Senior Optical Engineer will make key contributions to the design and development of ophthalmic medical devices, as part of a multidisciplinary team. Activities include optical design and component selection in the development of both light delivery and imaging systems. The successful candidate will work closely with the hardware, software, and applied research teams to develop new technologies and methods to improve and advance ophthalmic diagnostic and therapeutic technologies.

Responsibilities
· Key contributor to all aspects of optical and optomechanical design of our corneal crosslinking devices, from initial concept and prototyping to manufacturing hand-off and sustaining engineering activities.
· Collaborate with applied research, electrical, mechanical and software engineering teams, project management, operations, and quality assurance to accomplish department goals and objectives.
· Proficiency with optical design and analysis tools (e.g., Zemax) and mechanical CAD software (e.g., SolidWorks).
· Ensure that the development process is aligned with design control procedures.
· Definition and execution of verification and validation test protocols.
· Develop and implement testing procedures to ensure performance and reliability.
· Design of production tooling, test fixtures, and related procedures.
· Familiarity with medical device design controls, verification & validation processes, and regulatory requirements (e.g., FDA QSR, ISO 13485).
· Demonstrated experience designing machine vision/imaging systems and light delivery or illumination systems.
· Strong working knowledge of optical characterization techniques and test methodologies (e.g., imaging performance, MTF, beam profiling, radiometry/photometry, interferometry).
· Experience with optomechanical design of optical sub-systems, tooling, and precision alignment fixtures.
· Provide technical direction to other members of the product development team. · Self-starter with the ability to recognize and solve complex issues with minimal guidance.

Requirements
· Minimum of 5 years of experience in medical device product development environment from initial concept to commercial release.

· Development and design of machine vision/imaging systems and light delivery systems.
· Strong knowledge of optical characterization techniques and testing methodologies.
· Optomechanical design of sub-systems, tooling, and fixtures.
· Familiarity with medical device design control procedures and regulatory requirements.
· Proficient with Zemax and SolidWorks.
· Effective communication and collaboration skills.
· Ability to work at optical benches and in laboratory environments for extended periods.
· Ability to lift 40lbs when required
· Occasional work in manufacturing or cleanroom environments as required.]]> Tue, 31 Mar 2026 00:00:00 EDT 1

Independently executes all routine unit operations in Purification including change-over procedures, scheduling within the shift team, equipment cleaning and set up.

Able to perform in-process testing such as cell counting, spectrophotometry and environmental monitoring.

Monitors and controls weights, flows, volumes, temperatures, pressure, and pH.

Identify and report any issues related to manufacturing performance, process and safety to the team lead and assist in investigations of deviations

in order to facilitate continuous process improvement.

Train junior staff on unit operations such as bioreactors, cell separation, chromatography and tangential flow theory as well as CIP/SIP operations.

All training will be conducted with an emphasis on safety and completion of operations in a timely manner.

Collaborates within team and department in order to follow best practices and meet department goals.

Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement. Skills:    

• Experience working with established GMP procedures and bulk manufacturing is a plus.
• Technical knowledge of manufacturing systems, methods and procedures.
• Understanding of purification/cell culture processes.
• Possess effective troubleshooting skills with equipment and/or process.

Education:    

• Preferred, associates degree with (1) year closely related technical experience, preferably in a pharmaceutical or chemicals manufacturing environment

Pay Rate Range: $20-26/hr depending on experience 
 ]]> Tue, 31 Mar 2026 00:00:00 EDT 1

ABOUT THE POSITION

The Project Coordinator is a newly created role at Biotech, providing support to the Program Management function and ensuring operational excellence across functional program managers. Reporting to the Executive Director, Head of Program Management, the Project Coordinator is proactive and highly organized, with a strong ability to anticipate needs, manage competing priorities, and execute tasks efficiently.


KEY RESPONSIBILITIES

• Schedule program meetings and maintain program documentation, including meeting minutes, action logs, decision-trackers, risk lists, etc.
• Assist in creating and update program timelines and dashboards.
• Track and follow up on all action items and deliverables across cross-functional teams.
• Support coordination of cross-functional project plans.
• Shadow senior program managers to understand governance, scenario planning and cross-functional alignment.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in science/health discipline.
• 1-2 years of industry experience a plus
• Proficiency in Microsoft Office; Smartsheet a plus
• General program management knowledge
• Strong organizational, and problem-solving skills; ability to thrive in a dynamic, fast-paced environment.
• Excellent communication (written and oral) and interpersonal skills; able to collaborate effectively with internal stakeholders and external partners.
• A strong alignment with, and commitment to, Biotech’s mission, vision, and core values.

]]> Tue, 31 Mar 2026 00:00:00 EDT 0 Join Our Team as an Outbound Sales Specialist – Germany (North or West)
Are you a passionate sales professional with a knack for building long-term relationships? Do you thrive in dynamic environments where your ability to identify growth opportunities can truly make a difference? We are looking for an ambitious Outbound Sales Specialist to join our expanding team in Germany’s North or West regions. This is your chance to play a pivotal role in a fast-growing, innovative company specializing in high-quality veterinary products and animal health solutions. If you are results-driven, customer-focused, and eager to make an impact, we want to hear from you!

About the Role
As an Outbound Sales Specialist, you will be the driving force behind expanding our presence in the European veterinary market. Your main responsibilities will include engaging with pre-existing leads, nurturing relationships with clinics and veterinary centers, and converting prospects into loyal, long-term clients. Using a mix of outbound calls and virtual meetings, you will act as a trusted adviser, leveraging your hunter mentality to uncover new opportunities and reinforce existing partnerships. This role offers a unique chance to contribute to our ambitious growth plans while working independently in your designated regional area. Your efforts will directly influence our pipeline and sales success, making this a truly rewarding opportunity for a proactive sales professional.

What You Need to Succeed

• Proven 3-5 years of outbound sales experience, ideally in veterinary, healthcare, or related medical industries (not essential but advantageous)
• Hunter-gatherer mindset with a passion for selling and creating lasting customer relationships
• Fluency in German and strong command of English, with excellent communication skills
• Solid understanding of relevant medical or veterinary terminology is a plus
• Demonstrated success in building pipelines, closing deals, and maintaining 5+ year client relationships
• Strong interpersonal, negotiation, and presentation skills
• Ability to manage time effectively, work independently, and thrive in a target-driven environment

Nice to Have Skills

• Previous experience selling into veterinary clinics or clinical environments
• Knowledge of industry trends, competitors, or the veterinary market landscape
• Experience with CRM systems and pipeline management tools, preferably SAP Business One
• Willingness to travel regionally within North or West Germany for client meetings as needed

Preferred Education & Experience

• A background in sales, marketing, or a related field with a track record of success in outbound or field-based sales roles
• Experience in health-related industries or medical sales is highly desirable; others with a strong sales mindset and willingness to learn will be considered

Other Requirements

• Must reside in or be willing to relocate to the North or West of Germany
• Valid driver’s license and comfort with regional travel (company car allowance provided; vehicle not furnished)
• Ability to work within an EOR (Employer of Record) arrangement and comply with local employment regulations

If you’re ready to leverage your sales expertise within a supportive, growth-focused environment and help shape the future of veterinary healthcare in Europe, we encourage you to apply now. Join us and take your career to the next level—your next great opportunity awaits!
]]> Tue, 31 Mar 2026 00:00:00 EDT 1 *depending on exp

About This Role:
This is an exciting opportunity for a talented individual to join a small team supporting a growing medical device startup. We are currently seeking a highly motivated and detail-oriented individual to join our team as a Product Builder. As a Product Builder, you will play a crucial role in the manufacturing process, ensuring the highest quality standards are met for our products. In all actions, this person shall demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Your Responsibilities Will Include:
• Assemble and build orthopedic implants and instruments according to established procedures and specifications.
• Perform quality checks and inspections to ensure products meet the required standards.
• Maintain a clean and organized work area to ensure efficient workflow and adherence to safety protocols.
• Collaborate with cross-functional teams to troubleshoot and resolve any manufacturing issues.
• Follow all company policies and procedures to ensure compliance with regulatory requirements.
• Contribute to process improvement initiatives to enhance productivity and product quality.
• Meet production targets and deadlines while maintaining a high level of accuracy and attention to detail.


Minimum Qualifications
• High school diploma or equivalent; technical or vocational training in a related field is preferred.
• Proven experience in a manufacturing or assembly role, preferably in the medical device industry.
• Strong manual dexterity and ability to work with small tools and components.
• Excellent attention to detail and ability to follow precise instructions.
• Basic understanding of quality control principles and practices.
• Ability to work effectively in a team environment and collaborate with colleagues.
• Commitment to maintaining a high level of integrity and professionalism.


Preferred Qualifications:
• Prior experience in orthopedic implant manufacturing or medical device assembly.
• Knowledge of FDA regulations and ISO standards related to medical device manufacturing.
• Familiarity with Lean Manufacturing principles and continuous improvement methodologies.


Other
• Ability to lift up to 20 pounds
• Ability to wear clean room clothing and work in a cleanroom environment]]> Mon, 30 Mar 2026 00:00:00 EDT 1 Must Have

• Human Factors Validation - Study Design, Protocol, and Report
• use-related risk analysis
• User Testing - Generative, Formative, Summative

Responsibilities may include the following and other duties may be assigned.

Applies human performance principles, methodologies, and technologies to the design of human-machine systems and products. Develops and implements research methodologies to test and evaluate developmental prototypes used in all phases of products development and processes. Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users. Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized humanmachine interfaces. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Mon, 30 Mar 2026 00:00:00 EDT 1 Pay range: 18-19/hr
*depending on experience

The Bottling Technician 1 for the BMIA group will be responsible for filling, capping, labeling, and completing batch records, and putting away Finished Good Inventory (FGI). They will also be responsible for kit assembly and product pouching. This is a highly team-oriented group which involves working closely with other core teams within the BMIA Departments (LEGENDplex and ELISA) as well as other departments such as Planning, Receiving, Inventory Control, Custom Solution Team (CST), Packaging, MCI, and Quality Control groups

Skills:

• Adhere to all BSL2 safety policies, correct procedures, dress code and health/safety guidelines
• Follow line clearance policies to avoid cross contamination, mix-ups or incorrect items bottled
• Perform kit assembly processes and pouching processes
• Perform various bottling related tasks to include dispensing antibody solutions, capping and labeling of vials, tubes or bottles.
• Verify materials and documents to ensure information such as concentrations, lots number etc. are correct.
• Ability to perform simple Math calculations.
• Put away finished good products in their designated temperature conditions.
• Use computer programs such as Microsoft Excel.
• Set-up and prepare equipment for ongoing operations.
• Operate computer-controlled process support/process equipment (i.e., filling line, lyophilizer, capping, labeling machines, etc.).
• Correctly follow SOP instructions for completion of job tasks.
• Clean and maintains work area and all lab equipment and supplies, adhering to 5S guidelines
• Maintain accurate training record and ensure on time completion of training documents
• Follow all GDP policies
• Other projects or responsibilities as required.

Education:

• High school diploma/GED or some college.
• 6 months of experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment

]]> Mon, 30 Mar 2026 00:00:00 EDT 1

We are seeking a Senior Electrical Engineer to lead the design and development of advanced electro?mechanical products within a highly regulated environment. This role spans the full product lifecycle — from early technology development through to verification, commercialization and ongoing enhancements. You will work closely with cross?functional teams globally, while mentoring junior engineers and driving technical excellence across multiple projects.
What You’ll Do

• Design electronic assemblies and PCBAs for complex electro?mechanical products.
• Ensure all electrical designs meet regulatory and compliance requirements (UL, IEC, FDA).
• Conduct EMI, safety and manufacturability testing to ensure robust, compliant designs.
• Collaborate with mechanical, software, systems and quality engineering to align schedules, budgets and project milestones.
• Apply failure?analysis and root?cause investigation skills to resolve product or component issues.
• Generate detailed design specifications, test protocols and technical reports.
• Contribute to and lead technical design reviews to ensure electrical integrity and product safety.
• Mentor junior engineers and support team capability development.

What You Bring

• 4+ years’ experience in electronics engineering with strong analog, digital and mixed?signal circuit design, plus PCB development.
• Experience designing regulated products, ideally within the medical device sector, including exposure to UL, IEC, FDA and EMI/EMC testing.
• Full product?lifecycle experience developing and verifying electro?mechanical systems from early concept through commercialization.
• Hands?on experience with failure analysis, root?cause techniques and writing design specifications, test protocols and technical documentation.
• Degree in Electronics Engineering or equivalent relevant experience.
• Excellent communication skills and ability to work effectively within cross?functional teams.

]]> Mon, 30 Mar 2026 00:00:00 EDT 1
The ideal candidate will have 1-2+ years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries. While a bachelors degree in a relevant scientific field (e.g., biology, chemistry, biochemistry) is preferred, direct industry experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, highly cross-functional environment. This role requires individuals who are proactive, able to work independently with minimal oversight, and comfortable escalating issues appropriately. Candidates seeking long-term opportunities with potential for FTE conversion will be prioritized; this is not intended for short-term or transitional job seekers. Fresh graduates without industry experience will not be considered.

This position supports Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations . Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Preferred Qualifications:
• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
• Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.
Also, ability to make Quality based decisions in order to ensure compliance.
• Experience managing projects through to completion & meeting timelines.
• Evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives.]]> Mon, 30 Mar 2026 00:00:00 EDT 1

We are seeking a Lead Mechanical Design Engineer to drive the design, development and verification of complex medical devices across both capital equipment and disposable components. This is a hands?on technical leadership role where you will guide cross?functional teams, oversee full lifecycle engineering, and deliver innovative, manufacturable and compliant solutions within a regulated environment.
What You’ll Do

• Lead the end?to?end design, development and verification of complex assemblies, sub?assemblies, components and packaging.
• Select materials, manufacturing processes, tooling and automation solutions to meet performance, cost and scalability needs.
• Translate product requirements into detailed engineering specifications and conduct feasibility studies and proof?of?concept testing.
• Drive design and process optimisation to improve quality, performance and manufacturability.
• Lead risk?management activities including PHA, FTA and dFMEA/uFMEA.
• Perform root?cause analysis and implement corrective actions following failure investigations.
• Collaborate with manufacturing teams to troubleshoot issues and refine process parameters.
• Manage projects or sub?projects, guide cross?functional teams and apply structured project?management methodologies.
• Support supplier and subcontractor activities and lead technical reviews with internal and external stakeholders.
• Provide team leadership including recruitment, performance oversight and daily activity coordination.
• Stay current with emerging engineering tools, technologies and methods to elevate team capability.

What You Bring

• 5+ years’ experience in medical?device mechanical design, ideally spanning capital equipment and disposable components.
• Full product?lifecycle experience: design, development, verification and optimisation.
• Strong background in material selection, manufacturing processes, GD&T, DFM/DFA, DOE and root?cause analysis.
• Proven experience running risk?management activities (PHA, FTA, dFMEA/uFMEA).
• Demonstrated project and team leadership, with clear ownership of deliverables and cross?functional coordination.
• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering or equivalent.
• Deep understanding of design for manufacturability/assembly and modern engineering practices.
• Strong communication skills and ability to influence decisions through technical insight.
• Familiarity with medical?device regulatory frameworks (ISO 13485, MDR, FDA 21 CFR 820).

]]> Mon, 30 Mar 2026 00:00:00 EDT 1 Pay 50-55/h depending on experience

HM's Top Needs:

1. Project Lead/Management experience

2. Medical devise or pharmaceutical/biotechnology background

3. Background in manufacturing engineering or Quality engineering

Education Required: Bachelor’s degree in life science, Biomedical, Mechanical, Industrial or Quality Engineering, Business Administration  

Years’ Experience Required: +2 years

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours

Work Location:

                Do they need to be local to any MDT office and if so where? NO, Remote

Does this person need to be on site? If so, full time or part time? No, Remote



MDR implementation project manager:  Responsibilities may include the following and other duties may be assigned. Supports one or more Cardiac Surgery MDR project across functional and regional organizations. Coordinates all facets of the project(s) from intake through implementation and closure. Accountable for the successful implementation of the outcomes the MDR implementation projects, MDR remediation assignment, etc. Focus on finding resolution, planning and control, change and prioritization of the projects deliverables at Grand Rapids. . Ensures the project adheres to all Corporate and IT policies and standards. Responsible for effectively managing the site constraints: Schedule all label verification activities with operation and help support the MDR engineering team to reveiw and complete the change orders relted to these activities. Provides technical and analytical guidance and recommendations to project managers of Grand Rapids projects. Keeps current on advances and best practices in project management methodologies.

SPECIALIST CAREER STREAM: Typically, an individual contributor with responsibility in a professional discipline or specialty. Support projects assigned as site MDR project lead and works with other stakeholders to achieve desired results. The majority of time is spent delivering and organsing site related deliverables and other aspect of the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University) and/or experence and skills.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with complete alignment with project managers and MDR Implementation program manager to strategize, implement and complete all the related adeliverable. Work of complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex. Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with project managers and regularly report out the activities progress of the projects. External interactions with suppliers, PO generation, etc. if necessary. Contact’s others to share information, status, needs and issues to inform, gain input, and support decision-making.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with 2 years of experience. MDR experience is prefered. 
]]> Mon, 30 Mar 2026 00:00:00 EDT 1 Technical Sales Manager

Reports to: Patrick Sze (GM)

Reason for need: New hire due to growth

Summary

• Will involve identifying opportunities for Bioquell portfolio - need a BD / hunter background
• Regional role for APAC including whole of APAC including Japan, China & India and will be the teams subject matter expert for the product

Requirements

• degree in chemistry, pharmaceutical science, or other life science area - preferred
• Because Bioquell's products are very unique, candidates can come from pharma manufacturer or pharma distributor backgrounds, or cleaning / disinfectant companies providing they have a strong understanding of regulatory frameworks
• Ideally have regional experience at least across some countries if not all APAC
• Ideally have experience managing distributors

Interview process:

• 1st stage - HR (teams),
• 2nd stage - Patrick (f2f in SG), 3rd stage with Head of APAC - Jenny Tang (f2f in SG)
• Possibly 4th stage but unlikely - tried to streamline but they all travel so much they cannot find matching times

Candidates in play? none

Salary 

• Basic: S$ 8,000-10,000 x 13months
• Hp allowance: S$ 150
• Transport Allw: S$1,100 (own a vehicle)
• SIP: 30% of ABS

Approved to hire? They have divisional approval granted and just need to open the job req internally

 ]]> Mon, 30 Mar 2026 00:00:00 EDT 1

We are supporting a cardiovascular medical devices organisation seeking a Clinical Specialist to provide high quality support across TAVI and coronary interventions throughout Austria. This role partners closely with interventional cardiologists and cath lab teams, ensuring excellent clinical guidance and strong adoption of advanced structural heart and coronary technologies.
The Opportunity
You will be the clinical expert for your territory, delivering case support in the cath lab, training clinical teams, and helping to drive the successful use of TAVI and coronary solutions. You will work closely with commercial colleagues while maintaining a strong patient focused and education led approach.

---

What You Will Do Clinical Support in Procedures
• Provide in procedure support for TAVI and coronary interventions across Austria
• Guide clinicians and cath lab staff on product preparation, deployment techniques, and best practice
• Ensure safe and effective use of devices through clear technical and procedural expertise
Customer Education and Engagement
• Build strong relationships with interventional cardiologists nurses and allied health professionals
• Deliver workshops in service training and clinical education programs
• Act as the trusted clinical partner for all TAVI and coronary related queries
Collaboration with Commercial Teams
• Partner with the sales organisation to support product adoption and territory growth
• Identify education opportunities that strengthen customer confidence and product utilisation
• Maintain an expert understanding of market trends and competitor activity
Territory Presence and Support
• Provide consistent support across key hospitals and cath labs within Austria
• Offer pre procedure preparation and post procedure follow up to ensure continuity of care and customer satisfaction

---

About You
• Clinical background in cardiology cath lab nursing physiology or similar field
• Experience with TAVI and or coronary interventions is strongly preferred
• Confident communicator who performs well in high pressure clinical environments
• Strong relationship builder with a calm and supportive approach during procedures
• Organised proactive and committed to delivering excellent patient centred outcomes
• Able to collaborate effectively with clinical and commercial teams
]]> Mon, 30 Mar 2026 00:00:00 EDT 1
• 80% - Enter and verify large amounts of information accurately and consistently from process Batch Records
o Manage and Track workload, ensure all necessary process data is located entered
o Develop and utilize existing tools to examine, manage and track workload
o Provide timely and accurate entry of process data in support of daily process monitoring and associated activities
o Manage special requests for data collection, completion and/or verification
o Help to Ensure all data entry system procedures and guidelines are accurate and current
o Ensure 100% accuracy of all information entered, right first time

• 5% - Understand Basic Processing and Analytics
o Will develop and understanding of the relationship between data collection and process monitoring
o Will develop understanding of basic manufacturing process technologies, terminologies and analysis tools
o Will develop an understanding of the Statistica Enterprise Architecture such that this knowledge can be applied to creation and maintenance of data collection systems

• 5% - Interaction and user support for data consumption and analytics
o Routinely interact with data consumers, help to create necessary efficiencies
o Work to build user confidence in the system
o Observe how the companies users interact with GDM, understand their needs provide support as required
o Resolve data entry related analytics problems with users

• 10% - Training:
o Follows all training and policy guidelines established for the facility as well as all cGMP requirements. Ensures employee training profile is up to date at all times by regular monitoring of training lists (e.g. ComplianceWire, SAP Learning Portal) and completing all training in a timely fashion.

• Perform other duties as assigned.

High School Diploma or Equivalent
0-3 years of biotech industry as well as relevant data collection systems exposure preferred
Solid computer skills including Microsoft Office a must
Detail oriented, Self-motivated, able to work independently.

Pay ranges between 20-25/hr]]> Mon, 30 Mar 2026 00:00:00 EDT 1

• Design and execute preclinical in vivo studies in collaboration with discovery and data scientists, develop timelines and action plans to meet company goals.
• Choose appropriate in vivo models and develop protocols with relevant endpoints for evaluating the mechanism of action, efficacy, and safety of therapeutic candidates.
• Perform hands-on in vivo experiments, including orthotopic tumor cell implantation, IV, IP and SC injections, in vivo imaging, and animal welfare monitoring.
• Perform biological sample collection and processing, MACS/FACS cell sorting, immune cell profiling using multicolor flow cytometry, immunogenicity testing using ELISA and ELISPOT, and cell-based functional assays.
• Generate, document, analyze and interpret experimental data to support critical decisions.
• Manage external laboratories and partners.

Required Skills & Qualifications

• • PhD in Life Sciences with specialization in oncology or immunology.
  • At least 3 years of hands-on experience working with murine tumor models in an
  • industry and/or academic setting.
  • Demonstrated independent ability to design, execute and interpret experimental data.
  • Demonstrated experience in in vivo procedures, such as rodent surgery and IV dosing.
  • Experience with tissue handling and processing, cell sorting, multi-color flow cytometry and cytokine profiling, experience with IHC and ISH is a plus
  • Proficiency in mammalian cell and tissue culture.
  • Detail-oriented, with strong organizational and record-keeping skills.
  • Excellent communication skills and ability to collaborate effectively in a cross-functional team.
  • Experience working in a GLP or regulatory-compliant environment is a plus.

  ]]> Mon, 30 Mar 2026 00:00:00 EDT 0
TECHNICAL SKILLS
Must Have

• Advanced Excel
• Experience with SAP

Nice To Have

• Access Database Management
• Advanced SQL
• Microsoft Power BI
• Microsoft SQL Query Analyzer
• Tableau

Key Responsibilities:

• Collect, validate, and organize data related to payments and transfers of value to healthcare providers in support of federal Sunshine Act reporting requirements
• Assist in the preparation and submission of accurate and timely Open Payments reports to CMS, ensuring compliance with all applicable regulations and internal policies
• Perform data quality checks to identify discrepancies, missing information, or potential reporting errors in payment and transfer of value records
• Support the reconciliation of financial data across multiple systems including accounts payable, expense management platforms (Concur), and CRM databases
• Maintain detailed documentation of data sources, validation procedures, and reporting methodologies to support audit readiness
• Generate regular reports and dashboards to track reporting metrics, submission deadlines, and compliance status for stakeholders
• Collaborate with cross-functional teams including Legal, Finance, Commercial Operations, and Medical Affairs to gather required data elements
• Respond to data queries from healthcare professionals regarding reported payments and assist with dispute resolution processes
• Monitor regulatory updates and guidance for global transparency reporting requirements from CMS and other jurisdictions as needed
• Maintain organized records and filing systems for all Sunshine Act documentation in accordance with retention policies
• Other duties as needed

 

Education & Experience:

Bachelor’s degree in Data Analytics, Business Administration, Public Health, or related field with 1-2 years of relevant experience
]]> Fri, 27 Mar 2026 00:00:00 EDT 1
• Lead the execution of all Cleaning Validation activities (CV/SIP PQ/CHT/SHT studies), including protocol generation, field execution, data retrieval/verification, sample management following a Lifecycle Approach and using Kneat.
• Supports non-traditional work schedule based on project and business needs
• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Conduct cleaning validation studies, including sampling, testing, and data analysis.
• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.
• Support the development of the periodic cleaning monitoring program.
• Benchmark against the broader network and external industry with the aim of achieving best-in-class standards and practices, expands and shares knowledge throughout the network to achieve excellence in Cleaning Validation.
• Support assigned teams as required to provide Cleaning Validation guidance.
• Review and coordinate Change Controls with Cleaning Validation impact as required.
• Lead and support continuous improvement by identifying and implementing projects to eliminate waste and improve cleaning times through CIP Optimization.
• Perform risk assessments to identify potential contamination sources and establish appropriate cleaning procedures]]> Fri, 27 Mar 2026 00:00:00 EDT 1

Für diese Position suchen wir eine klinisch versierte Persönlichkeit, die sich im OP souverän bewegt und Freude daran hat, Kunden fachlich wie kommerziell zu betreuen. Die Rolle verbindet regelmäßige Präsenz im Operationssaal mit Kundenmanagement, Schulungen und dem Ausbau eines etablierten Vertriebsgebiets.
Ihre Aufgaben

• Betreuung und Ausbau bestehender Kunden sowie aktive Neukundenakquise
• Eigenverantwortliche Betreuung aller Kund:innen im zugewiesenen Gebiet
• Pflege und Weiterentwicklung der Kundendatenbank
• Durchführung von Verkaufs- und Trainingsmaßnahmen sowie Präsentationen vor Ort
• Entgegennahme und Weiterleitung von Bestellungen und Anfragen
• Umsetzung aller vertriebsrelevanten Aktivitäten: Produkteinführungen, Präsentationen, Vertragsunterstützung
• Umsetzung von Vertriebsstrategien sowie Erstellung von Markt- und Wettbewerbsanalysen
• Steigerung von Umsatz und Marktanteilen
• Unterstützung des Sales Managers bei Schulungen und Kundenedukation
• Repräsentanz auf relevanten Kongressen und Fachveranstaltungen
• Enge interne Zusammenarbeit mit Key Account, Marketing, Health Economics und weiteren Teams
• Verantwortung für monatliche, quartalsweise und jährliche Zielerreichung
• Planung und Steuerung des Vertriebsbudgets
• Klinische Einweisung von Pflegepersonal, insbesondere im OP
• Annahme und interne Weiterleitung von Reklamationen

Ihr Profil

• Ausbildung/Hintergrund als Krankenpfleger:in oder Rettungsdienstfachkraft, unbedingt mit Erfahrung im Operationssaal
• Erste Vertriebserfahrung (ab ca. 1,5 Jahren)
• Verhandlungssichere Deutschkenntnisse sowie gutes Englisch
• Kommunikationsstark und sicher im Umgang mit OP-Personal
• Hohe Belastbarkeit und Bereitschaft für lange Einsätze im OP
• Reisebereitschaft (ca. 80–90 %)
• Teamorientierte Arbeitsweise

]]> Fri, 27 Mar 2026 00:00:00 EDT 1 Additional position details from the manager below:

Can you please confirm your top 3 skills sets required?  Production support, communication, critical thinking

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Day-to-day production floor support, NCMR processing, CAPA processing

What products (if any) will this role support?  Mechanical Heart Valves

What is your target years of experience?  1-5 years of experience

 
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience]]> Fri, 27 Mar 2026 00:00:00 EDT 1
Execute QC activities, working with the day and night shift managers, including sample receipt, prioritization, and accurate entry into LIMS.

Perform routine and complex analytical testing in chemistry, bioassay, and/or microbiology, including STAT testing as required.

Ensure accurate, compliant documentation in accordance with GDP, GMP, and 21 CFR Part 11 requirements.

Support laboratory investigations related to deviations or OOS results and communicate shift-level risks to QC leadership.

Utilize electronic systems including LIMS, Biovia (LES, ELN, CIMS/CISPro), and Veeva Vault (QualityDocs, QMS).

Collaborate cross-functionally to meet testing timelines and contribute to continuous improvement initiatives.

Preferred - Bachelors degree in a scientific discipline or equivalent experience, entry level will be considered.

Experience working in a GMP-regulated environment and ability to work independently.]]> Fri, 27 Mar 2026 00:00:00 EDT 1 Lead quality management initiatives across a manufacturing site, ensuring product quality, regulatory compliance, and operational excellence. Oversee testing of raw materials, intermediate and finished products, and coordinate with internal teams and external partners to maintain high-quality standards.
Key Responsibilities

• 
  Develop departmental goals and prioritize initiatives aligned with quality strategies.
  
• 
  Manage evaluation and testing of materials and products, including stability studies, process validation, and investigations.
  
• 
  Collaborate with production, supply chain, and external partners to resolve quality issues and implement improvements.
  
• 
  Maintain and improve quality assessment systems, SOPs, and reporting to support decision-making.
  
• 
  Ensure compliance with regulatory standards and promote a safe, effective working environment.
  
• 
  Lead, mentor, and develop the quality team to strengthen technical capabilities and operational performance.
  

Qualifications

• 
  Bachelor’s degree in Chemistry, Pharmacy, Agriculture, or related field.
  
• 
  5+ years of experience in quality control, regulatory compliance, or analytical chemistry.
  
• 
  Strong knowledge of GMP, regulatory frameworks, and quality assurance principles.
  
• 
  Analytical, detail-oriented, and skilled in problem-solving and team collaboration.
  
• 
  Japanese: Native or business-level proficiency; English: Business-level proficiency.
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Fri, 27 Mar 2026 00:00:00 EDT 1 Primary Responsibilities for Role:

• Electrical and Instrumentation (E&I) Engineer for the pharmaceutical industry.
• Will be required to manage assigned scope, cost, and schedule for responsible duties.
• Will work in all phases of capital projects: planning, design, procurement, construction and start-up:
• Design of low voltage power distribution and motor control.
• Responsible for selection and sizing of instrumentation based on P&IDs.
• Selects control system hardware based on site standards.
• Prepares equipment specifications and bid packages.
• Performs vendor & bid evaluations, progress monitoring and attendance of factory acceptance testing.
• Responsible to field supervise contractors during construction to ensure safety, quality and schedule.
• Responsible for providing contractors answers to questions that arise during construction.
• Performs equipment start-up, develops and executes commissioning protocols and prepares turnover packages for the site.
• Develops single lines, motor control schematics and loop sheets.
• Sizes electrical components based on NFPA 70.
• Modifies existing or develops new specifications to meet requirements of project scopes.
• Coordinates with other disciplines throughout design, construction and startup.
• Provides initial configuration settings for VFDs and Motor Starters.

Communication - Will be responsible for providing communications (verbal/written) within area of responsibility.

Use/demonstrate problem solving skills in order to best support and meet the needs within area of responsibility.

Promotes a collaborative and cooperative environment which embraces the ability to work effectively within teams.

Capable of adhering to Good Manufacturing Practices (GxP) - Compliance, Change Control, Quality Oversight, Validation.
 

Education and Experience requirements based on level:

Staff Engineer Level:

Minimum Education: Bachelor's Degree in Engineering or related field.

Professional registration and/or certifications as appropriate.

Minimum of 5 years of related experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred.
 

Principal Engineer Level:

Minimum Education: Bachelor’s Degree in Engineering or related field.

Professional registration and/or certifications as appropriate.

Minimum of 8 years of experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred.
 

 Additional Requirements:

PE license in NC preferred.

Will require occasional international travel (i.e. Spain, Canada)
 

 

Occupational Demands:

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.
]]> Fri, 27 Mar 2026 00:00:00 EDT 1 Seeking a talented and highly motivated Senior associate Scientist/Scientist to join our Immuno-oncology group. Our collaborative and interdisciplinary research team utilizes state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.

The successful candidate is expected to contribute to the discovery, research, and development of novel immunotherapeutic agents to address unmet medical needs of cancer patients. S/he/they will have opportunities for career growth through acquisition of new skills and professional relationships in a fast-paced and resource-rich environment.

Key Responsibilities
• Independently execute in vitro and in vivo immunological assays, with study design, data analysis, and interpretation conducted under scientific guidance to support drug candidate initiation and advancement.
• Proactively evaluate new technologies and develop new assays to accelerate early-stage discovery activities and/or enhance our understanding of disease mechanisms
• Manage multiple projects simultaneously and work cross-functionally with colleagues in the oncology, protein engineering, chemistry, translational medicine, biomarker and clinical groups
• Presents research findings and recommendations to senior staff and contribute to preparation of research reports, manuscripts, INDs, and patent filings

Knowledge, Experience and Skills
• Master's degree with 5+ years of experience, or Bachelor's degree with 8+ years of experience in immunology, immuno-oncology, cell biology, molecular biology, or biochemistry in industry or academia.
•Direct experience in research drug discovery and target identification/validation in oncology or immuno-oncology is highly desirable.
• Solid understanding of fundamental immunology concepts, including innate and adaptive immunity, antigen presentation, cytokine signaling, and immune regulation.
• Proficiency in primary T cell-based functional assays such as activation, proliferation and cytotoxicity.
• Experience in conducting and optimizing cell-based assays, as well as performing studies to assess immune responses in human and animal models (including whole blood, PBMCs, and various primary cell subsets).
• Hands-on experience in general molecular and cell biology methods, including mammalian cell culture, multi-color flow cytometry, western blot, ELISA/Luminex/MSD, and CRISPR technology.
• Highly organized, with demonstrated rigor in documenting experimental design, execution, and data analysis.
• Excellent written and verbal communication skills, with the ability to work effectively in a collaborative, cross-functional environment.

Pay ranges between 50-57/hr based on experience ]]> Fri, 27 Mar 2026 00:00:00 EDT 1 Job Description
The Payer Relations Director (PRD) leads payer strategy within an assigned region to secure and maintain favorable coverage, coding, and reimbursement across commercial plans, Medicare (MACs), and Medicaid. This role drives access for current and newly launched products by establishing payer relationships, resolving reimbursement barriers, and ensuring fair and consistent payment. The PRD partners cross-functionally with Sales, Reimbursement Liaisons, Medical Affairs, and Customer Relations to support KOL physicians and institutional customers, influence payer policy, and enable provider adoption and patient access. Serving as a subject-matter expert in payer policy and buy-and-bill reimbursement, the PRD engages with medical directors, MACs, state agencies, and advocacy groups to build sustainable coverage pathways and support future technologies. Extensive field engagement and travel required.
What Will You Do? 

• Develop and execute regional and national payer strategies to secure and maintain coverage, coding, and reimbursement across Commercial, Medicare (MACs), and Medicaid.
• Partner with Sales and Reimbursement Liaison teams to support KOL providers, remove access barriers, and resolve complex reimbursement challenges.
• Build and sustain relationships with payers, MAC medical directors, state agencies, and advocacy organizations to influence policy and coverage decisions.
• Serve as the payer and reimbursement subject-matter expert, guiding internal teams and customers on buy-and-bill, coding, billing, and appeals processes.
• Drive access strategy for current and future technologies through cross-functional collaboration with Sales, Medical Affairs, and Customer Relations.
• Understand and work with key health care stakeholders within the following customers: * Commercial Managed Care (Regional Plans) * Medicare (Part A, B, C, D; Carriers) * Medicaid (Fee for Service, Managed Care Organizations) * State Government Health Staffers * Veteran's Administration (VISNs) * TRICARE Regional Offices * Specialty Pharmacy & Pharmacy Benefit Managers * Medical Groups * State Advocacy, patient, provider and other key healthcare stakeholder groups.

How Will You Get Here? 

• Bachelor's degree required; advanced degree or practice management experience preferred. 
• 10 plus years of industry experience in payer/reimbursement roles within medical devices and biologics (buy-and-bill, injectable products strongly preferred). 
• Minimum 2 years experience: practice management, practice billing and revenue cycle, public or private third party reimbursement related to product access impact on providers, or pharmaceutical/managed care industry reimbursement. 
• Proven experience with payer strategy, reimbursement, and account management; direct product launch experience highly desirable.
• Deep knowledge of Commercial, Medicare, and Medicaid reimbursement structures, coding (e.g., J/T codes), billing, and appeals processes.
• Strong executive presence and stakeholder engagement skills with payers, KOLs, health systems, and government entities.
• Highly organized, self-directed, and effective in cross-functional environments.
• Willingness to travel extensively (50% /  3-4 nights/week).

  ]]> Fri, 27 Mar 2026 00:00:00 EDT 1 A growing player in interventional cardiology is looking for a Coronary Area Sales Manager to establish and grow its footprint across Victoria. This is a role for someone with proven coronary intervention experience who wants ownership, pace, and the opportunity to influence how a territory is built.
About the Role
You’ll take charge of the coronary portfolio across Melbourne and broader VIC, working closely with interventional cardiologists, cath lab teams, and procurement. The focus is equal parts clinical support and proactive business development, with plenty of scope to open new doors and shape the commercial strategy.
Key Responsibilities

• Grow adoption of a premium coronary intervention portfolio across VIC.
• Provide case support, training, and product expertise in cath labs across the region.
• Build new relationships, unlock untapped accounts, and strengthen existing partnerships.
• Develop territory plans that prioritise high?impact opportunities and long?term growth.
• Represent the business clinically and commercially, ensuring strong visibility across key centres.

What You Bring

• 2+ years of recent coronary intervention sales experience — essential.
• Experience working with major coronary systems or authorised distributors.
• Maximum of 10 years’ total experience — suited to someone ambitious, adaptable, and not already in a management lane.
• Entrepreneurial approach — comfortable with market building, prospecting, and strategic thinking.
• Strong presence in clinical environments and a track record of influencing key decision?makers.
• Based in Melbourne with flexibility to travel across the state.

What’s on Offer

• Ownership of a major territory with high growth potential.
• Autonomy, visibility, and genuine influence over how the market is built.
• Competitive package and long?term development in a high?performing therapy area.

If you want to take the lead in building a coronary business in Victoria, this role gives you the chance to drive real impact from day one.
]]> Thu, 26 Mar 2026 00:00:00 EDT 1 Additional position details from the manager:

1. Can you please confirm your top 3 skills sets required?
   1. Proficiency and experience in developing and debugging C# code or other OOP languages.
   2. Experience with the development and execution of automated testing using automated test software language.
   3. Experience with the programming and the operation of electrical lab equipment such as oscilloscopes, power supplies, waveform generators, network analyzers, etc….
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
   1. Develop software for automated tests to communicate with medical devices and test equipment
   2. Perform Test Method Validation and Document Test Procedures
   3. Execute automated tests and summarize test data for review by Design Engineers.
3. What products (if any) will this role support? Various Cardiac Rhythm Management implantable products (Pacemakers, Defibrillators, Recorders)
4. What is your target years of experience? 4 years but flexible for the right candidate
5. When do you plan to start interviewing? I would do an informal phone/Teams interview as soon as I think I have a potential candidate
6. Will you be looking to hire and start ASAP or will the start date be delayed?  This will be a FY27 hire so the earliest start date will be the beginning of FY27
7. Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Fully onsite

In this role you will develop and execute electrical hardware automated tests related to the design and development of implantable cardiac medical devices. You will work closely with Design Engineers to understand product requirements and develop tests for those requirements. You will be expected to work independently and with minimal supervision.  Responsibilities may include the following and other duties may be assigned.

• Develop software for automated tests to communicate with medical devices and test equipment
• Perform Test Method Validation and Document Test Procedures
• Execute automated tests and summarize test data for review by Design Engineers.
• Communicate status of testing to Technicians, Test Engineers, Design Engineers, or Program Managers
• Ensure understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance.

Must Have: Minimum Requirements 

• Proficiency and experience in developing and debugging C# code or other OOP languages.
• Experience with the development and execution of automated testing using automated test software language.
• Experience with the programming and the operation of electrical lab equipment such as oscilloscopes, power supplies, waveform generators, network analyzers, etc….
• Ability to work onsite 5 days a week
• Strong troubleshooting skills

 Nice to Have: Preferred Requirements

• Experience working in a regulated industry, preferably medical devices
• Experience in writing test documentation
• Knowledge of Circuit Boards, electrical components, and Electrical Engineering basics
• Experience with Various Communication Protocols (RS-232, RS-485, GPIB, TCP/IP, Ether CAT, EtherNet/IP, etc.)
• Experience with C and/or C++
• Experience using Reflection in C#
• Experience with Python
• Experience with LabVIEW
• Strong interpersonal skills
• Strong written and verbal communication skills
• Strong attention to detail
• Demonstrated ability to work in cross functional teams
• Demonstrated ability to work with embedded systems
• Experience with performing Verification and Validation in a regulated industry

]]> Thu, 26 Mar 2026 00:00:00 EDT 1 HM's Top Needs:
1.  experience related to the management and negotiation of the Patient Informed Consent, specifically within the US

2.  document management and ability to follow standard operating procedures and appropriate document management (ensuring key stakeholders are engaged, documents are uploaded to the trial master file, all while ensuring quality of the content)

3.  relationship management and ability to work with diverse teams (study team, functional team, site research team)

 

Education Required: Bachelor’s degree, ideally in Clinical Research, Biology or Chemistry, and a

Years’ Experience Required: minimum of 2 years of experience working on consent/Informed Consent (IC)/contracts within clinical research


Responsibilities may include the following and other duties may be assigned. Administers, extends, negotiates and terminates standard and nonstandard contracts. Conducts proposal preparation, contract negotiation, contract administration, and customer contact activities to provide for proper contract acquisition and fulfillment in accordance with company policies, legal requirements, and customer specifications. Examines estimates of material, equipment services, production costs, performance requirements, and delivery schedules to ensure accuracy and completeness. Prepares bids, processes specifications, progress, and other reports; advises management of contractual rights and obligations; compiles and analyzes data and maintains historical information. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience.
]]> Thu, 26 Mar 2026 00:00:00 EDT 1 Position Summary:  Manager, Clinical Supplies Planning and Logistics

Structure is seeking a talented, independent, and highly motivated Senior Manager, Clinical Supplies Planning and Logistics with experience in clinical supply planning and logistics. They will also be involved in typical Clinical Supplies Manager activities including forecasting Investigational Product (IP) supply requirements, inventory management, and managing packaging, labeling, and distribution through 3rd party vendors, for one or more clinical trials. Will collaborate and interact internally with Clinical Operations, Medical Monitors, Program Management, Quality, Regulatory, Tech Ops/CMC and externally with Clinical Service Providers (e.g., IRT, CROs, IP Drug Depots). This position will report to the Head of Clinical Supplies Planning and Logistics, in the Clinical Development Operations department.
ESSENTIAL DUTIES AND RESPONSIBILITIES

• As part of the Clinical Supplies Planning and Logistics team, manages clinical supply and logistics activities, including but not limited to demand forecasting and supply planning, label generation and approval, packaging and labeling operations at clinical supply vendors, release and distribution, temperature excursion, expiry extension, drug return and destruction records, and inventory management.
• Management of IP vendors (performance, quality, timelines, results, costs): participates in review of RFP, reviews IP services vendors budgets.
• Collaborates with external partners (CMOs, CROs, shipping and IRT vendors, study sites) and study team members to ensure successful execution of clinical trials
• Collaborates with Clinical Operations and Regulatory Affairs to provide packaging and labeling strategy, including labeling and packaging design in compliance with relevant SOPs, polices, and regulations
• Works closely with QA to ensure compliance around IP documentation, procedures, Lot numbers, managing expiration dates, and coordinating release schedules.
• Manages the design and review of IP-related study documents (e.g., pharmacy manual, IP section of protocol) and training materials for clinical study teams and investigational site use as needed. Supports inspection team in preparation for and during regulatory agency inspection.
• Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File.
• Provides input to drug kit randomization specifications and reviews master kit lists

Qualifications:
Education

• BA/BS required, scientific discipline preferred. Other BA/BS degree with IRT and clinical supply experience will be considered.

Experience

• Understanding and proven experience in IRT/RTSM in large global blinded studies
• 6+ years of relevant experience in the biotechnology/pharmaceutical industry, including at least 3 years in clinical supply management using IRT in a small biotech-type of environment.
• Experience in small molecules (capsule and tablet) clinical supply planning and logistics for multi-center, blinded global studies preferred
• Experience in IP logistics in Latin America preferred
• Knowledge of global pharmaceutical regulatory requirements: cGMP, GCP, GDP
• Experience in forecasting, labeling, and distribution in a clinical environment

]]> Thu, 26 Mar 2026 00:00:00 EDT 0

An established medical technology organisation is expanding its structural heart and interventional cardiology clinical support team across Catalonia. The role focuses on providing high quality clinical expertise in TAVI and coronary interventions while working closely with cardiac centres to strengthen procedural standards and support wider therapy adoption.
What You Will Do
• Provide real time support during TAVI and coronary procedures and ensure safe and effective use of all devices across cath labs in Catalonia
• Deliver structured education and hands on training to interventional cardiologists nursing teams and cath lab staff
• Act as the primary clinical contact for therapy related questions supporting both clinicians and internal teams
• Support development of clinical competence across new and established sites including coordination of proctoring activity and continued case support
• Maintain up to date knowledge of clinical evidence procedural recommendations and evolving therapeutic approaches
• Contribute clinical insight to regional plans identifying opportunities to improve therapy utilisation and patient pathways
What You Bring
• Strong background in TAVI and or coronary intervention support gained in a hospital environment or within medical technology
• Demonstrated experience supporting complex procedures within cath labs or structural heart settings
• Confident communication skills with the ability to guide educate and influence senior clinicians
• Proven capability working closely with interventional cardiology teams in high pressure environments
• Readiness to travel across Catalonia
Education
• Degree in a clinical discipline such as nursing cardiac physiology radiography or biomedical science
]]> Thu, 26 Mar 2026 00:00:00 EDT 1
Cleaning Validation Specialist
Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies.
• Support authoring and executing CV/CHT/SHT protocols, progress package work and wrap up executed studies
• Supports non-traditional work schedule based on project and business needs
• Familiar with Drug substance process equipment, autoclaves, parts washers, CIP skids to support CV program
• Demonstrated proficiency in utilizing PI for run trending analysis and facilitating the successful completion of support packages.
• Leads and performs on floor CV execution and sampling. Provide technical support and sample management to cleaning activities associated with the manufacturing process.
• Proficient with KNEAT execution
• Design and develop cleaning procedures for new products and manufacturing equipment.
• Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
• Supports the periodic review of cleaning validation studies.
• Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to ensure cleaning validation activities are integrated into the overall project plan.
• Trains manufacturing and QC/QA personnel on cleaning validation documentation.]]> Thu, 26 Mar 2026 00:00:00 EDT 1
Overview
A leading organisation in medical technology is seeking a Clinical Specialist to support structural heart and interventional cardiology therapies in Toulouse and the surrounding region. This position focuses on providing expert clinical guidance during procedures, strengthening therapy practice, and supporting clinicians in delivering high quality patient care.
Your Responsibilities
• Provide in lab support for TAVI and coronary procedures across centres in the region and ensure safe and effective use of all relevant therapies
• Deliver structured education and ongoing training to interventional cardiologists cath lab nurses and wider clinical teams
• Act as the primary clinical contact for therapy related discussions supporting both clinical stakeholders and internal teams
• Support new site development proctor scheduling and continued clinical competence across all accounts
• Maintain detailed knowledge of current clinical evidence procedural guidelines and best practice in TAVI and coronary intervention
• Identify therapy growth opportunities and contribute clinical insights to wider territory planning
Your Experience
• Proven experience supporting TAVI and or coronary interventions gained in a hospital environment or within medical technology
• Background in providing in procedure support within cath labs or structural heart settings
• Strong communication skills with the ability to guide educate and influence senior clinicians
• Successful track record working closely with interventional cardiology teams in fast paced environments
• Readiness to travel across the Toulouse region
Education
• Degree in a relevant clinical discipline such as nursing cardiac physiology radiography or biomedical science
]]> Thu, 26 Mar 2026 00:00:00 EDT 1 Environmental Health & Safety is responsible for developing and implementing programs and policies that ensure the overall safety and health of employees and that enables compliant business operations.
Applies in-depth knowledge of EH&S laws, regulations and management systems.
Makes design recommendations with a basic understand of the Reference Architecture and Application Transition plan.
Has in-depth experience, knowledge and skills in own job family.
Applies knowledge and skills to a wide range of standard and non-standard situations.
Works independently with minimal guidance.
Usually determines own work priorities.
Acts as a resource for colleagues with less experience.

Job Summary:

The Environmental, Health, and Safety Engineer acts as the technical Subject Matter Expert, SME, for the sites
Environmental Health and Safety compliance and maturity.
The engineer researches and understands applicable norms, permits, and standards and integrates them into the site’s work processes and practices.
This individual either supports or leads sustainability projects across the site.
The Environmental, Health, and Safety Engineer assists in maintaining the site’s ISO 14001 certification by ensuring the site is always audit ready.


Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
· Key player in all Environmental, Health, and Safety initiatives on-site.
· Acting as the deputy EHS Leader when the EHS Leader is absent.
· Actively participates in Root Cause Analysis (RCA) investigations.
· Acts as a Subject Matter Expert as a member of the EHS Team.
· Participates as an EHS expert as a member of new equipment project teams, from design to operational stage.
· Acts as an influential leader in site safety and sustainability campaigns.
· Interacts with the authorities and insurance companies as site representative on technical EHS topics.
· Maintain technical expertise in Machine guarding, Lock out Tag out, and other relevant technical Safety programs.
· Maintain knowledge of the site Sustainability targets and projects to ensure their achievement and completion.
· Core contributor to the ISO 14001 certification.
· Participate as requested in EHS programs.
· A strong interest in bringing positivity to the workplace, including growing the Safety and Sustainability Culture and influencing the mindset of associates, peers, and superiors in a positive manner.

Education and Experience: 

Education
· Bachelor of Science degree in Environmental Engineering, Mechanical Engineering, Electrical Engineering, Process Engineering, or equivalent.
· Or a Bachelor of Science or Associate of Science degree in a Technical Field or Environmental Health and Safety, Occupational Health and Safety, and 5 or more years of relevant manufacturing experience.
Min of 5 years of experience in a manufacturing environment.
Experience leading EHS projects and teams.
Professional (ASP/CSP) or Certified Industrial Hygienist (CIH) certifications, preferred.
Experience in managing environmental compliance including reporting and record keeping, environmental permitting for manufacturing operations and regulatory compliance.
Experience in evaluating/interpreting OSHA, EPA and DOT regulations.
Title V reporting and regulations.
Experience in medical device or pharmaceutical manufacturing is preferred.
Knowledge and experience in ISO14001 compliance preferred
 

Basic Knowledge and Skills:
· Strong interpersonal skills in dealing with people at all levels and in various functions including technical staff, business team leaders, and union personnel. · Effective skills in the areas of counseling, coaching, and influencing. · Demonstrate understanding of federal and state safety and environmental laws.
· The ability to identify and evaluate workplace hazards and environmental issues. · Ability to work in a diverse team environment including interactions with technical staff, operation leaders, and contract personnel.
· Ability to lead a project or technical team and lead teams virtually.
· Ability to challenge the organization in a manner that maintains trust and respect.
· Ability to build business partnerships across and between functional groups.
· Ability to accept and respond to changes and challenges in a positive manner.
· Demonstrated capability to analyze problems and provide accurate solutions.
· Demonstrated skills in time management and managing multiple priorities.
· Critical thinking skills and the ability to constructively resolve conflicts.
· High energy and passion for excellence, adaptability, resilience, and taking action.
· Self-directed and comfortable working in a matrixed organization.
· Knowledge of standard computer programs and databases (MS Excel, Word, PowerPoint).

 
]]> Thu, 26 Mar 2026 00:00:00 EDT 1 Warehouse Supervisor - Sittingbourne (KSP), UK

Are you a seasoned leader with a passion for efficient warehouse operations and a commitment to quality and safety? We are seeking a dynamic and experienced Warehouse Supervisor to oversee our facility at Sittingbourne (Kent Science Park). This critical role is instrumental in ensuring smooth, compliant, and high-performing warehouse processes, supporting our company's dedication to excellence in supply chain management within a regulated environment. If you're ready to lead a motivated team and drive continuous improvement, this is your chance to make a significant impact.

Overview
As Warehouse Supervisor at Sittingbourne, you will take charge of managing all aspects of warehouse activities—including materials storage, distribution, sampling, and dispensing—within a cGMP and Health & Safety compliant framework. Your leadership will ensure operational excellence, proper resource management, and adherence to regulatory standards, supporting both the production and distribution functions. This role offers an exciting opportunity to lead a dedicated team in a fast-paced environment while maintaining the highest standards of safety, quality, and efficiency.

Required Skills

• Proven management or supervisory experience in a warehouse environment, minimum 3 years
• Strong understanding of supply chain functions, including raw material reception, storage, picking, dispatch, and stock control
• Excellent leadership skills with the ability to motivate, support, and develop a team
• Solid knowledge of warehouse management systems (ERP, eQMS) and MS Office Suite
• Exceptional attention to detail and data accuracy
• Effective communication skills, both verbal and written
• Ability to manage multiple priorities and adapt to changing needs
• Commitment to Health & Safety and GMP standards in a regulated environment
• Experience in completing and reviewing quality and safety documentation such as SOPs, risk assessments, and audits

Nice to Have Skills

• Pharmaceutical industry experience or familiarity with cGxP standards
• Experience with temperature-controlled storage and monitoring systems
• Knowledge of automated storage and retrieval systems (ASRS)
• Project management or continuous improvement methodology experience

Preferred Education and Experience

• A minimum of 3 years’ proven supervisory or management experience within a warehouse setting
• Knowledge of supply chain disciplines, ideally within a regulated or pharmaceutical environment
• Relevant certifications or training related to health and safety, logistics, or warehouse operations

Other Requirements

• Ability to work flexible hours to ensure all activities are delivered OTIF
• Willingness to support out-of-hours support for plant alarms and emergencies
• Capable of conducting warehouse tours and liaising with external bodies and regulatory authorities
• Valid knowledge of relevant health, safety, and environmental standards, including risk assessments and COSHH requirements

If you’re ready to lead a key logistics operation within a regulated environment, driving performance and continuous improvement, don’t miss this opportunity. Apply now to join a forward-thinking team committed to excellence in warehouse management!
]]> Thu, 26 Mar 2026 00:00:00 EDT 1
Reporting to the the Director of DMPK and this person will have strong experience with Si RNA.  

MAJOR DUTIES AND RESPONSIBILITIES:

• Responsible for scientific quality, technical and operational aspects of the Drug Metabolism/ DMPK/ Bioanalytical group in support of Discovery and Development Project Teams.
• Identifies and keeps pace with evolving/ novel technologies and implementation as appropriate  
• Designs appropriate studies/ endpoints and interprets and disseminates the data to the internal project teams and management.
• Accountable for scientific excellence in Discovery, setting the standard for quality research within the DMPK group.
• Facilitates the transition of candidate compounds from Discovery to Development and coordinates execution of plans with key stakeholders.  
• Maintains productive communications with Chemistry, Biology, and Development colleagues.
• Establishes effective partnerships/relationships through collaboration, expertise in current and future analytical technologies, and seamless transfer of information. Encourages and supports collaboration across departments and takes actions that will increase the likelihood of positive outcomes in Research.

EDUCATION REQUIREMENTS: 

• Ph.D. in Pharmaceutical Sciences with relevant field experience in Bioanalysis, Metabolism and Pharmacokinetics supporting drug discovery and development of SMOLs and Biologics (Protein Therapeutics).

EXPERIENCE REQUIREMENTS: 

• Minimum of 8 years of experience in the above areas in the pharmaceutical industry

]]> Thu, 26 Mar 2026 00:00:00 EDT 0
Summary:
The main function of a clinical operations analyst responsible for efficient processing and quality check of all study documents.

Key Responsibilities:
• Conduct periodic audits of documentation and may participate in internal master file audits
• Review and ensure accuracy and completeness of clinical study files and/or device accountability logs, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
• May be required to work in the coordinator role as dictated by business needs
• Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Other incidental duties (e.g. occasional photo copying or deliveries)

Additional Skills:
• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
• Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred
• Good written and verbal communication skills and interpersonal relationship skills
• Ability to work in a fast paced environment
• Substantial knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint
• Good problem-solving skills
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Must be able to work in a team environment under minimal supervision
• No instructions needed on routine work, and general instructions given only on new lines of work or special assignments
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education and Experience:
• H.S. Diploma or equivalent
• 5-7 years of experience required]]> Wed, 25 Mar 2026 00:00:00 EDT 1 SUMMARY/JOB PURPOSE:
Bridges the gap between business process knowledge and AI-enabled tooling by translating operational efficiency concepts into automated IT tools. Supports the Business Operations team through dashboard development, IT systems administration, and the design and maintenance of structured AI workflows that help the team work smarter and faster.

Essential Duties And Responsibilities:

• Partners with Business Operations leaders to identify and document operational pain points and efficiency opportunities; translates those concepts into tools that can be deployed across the team
• Designs, builds, and maintains operational dashboards that surface key metrics, contract status, workload visibility, and team performance indicators for internal stakeholders
• Supports IT systems used by the Operations team—including contract lifecycle management (CLM) platforms—by managing configurations, troubleshooting issues, and coordinating with IT partners
• Tests and iterates tools, validating outputs against real operational scenarios and refining prompt logic, context windows, and structured instructions based on user feedback
• Documents AI workflows, skill libraries, and system configurations in a clear, maintainable format so that knowledge can be transferred and built upon by the broader team or future contractors
• Collaborates cross-functionally with Operations and IT to understand evolving workflow needs and propose tool-based solutions that reduce manual effort and improve consistency

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:

• Bachelor’s degree (B.A./B.S.) in Information Systems, Computer Science, Business, or a related field preferred; minimum of three years of relevant experience; or equivalent combination of education and experience

Experience/The Ideal for Successful Entry into Job:

• Hands-on experience building or maintaining Claude skills, GPT custom instructions, LangChain chains, or similar structured prompt/workflow assets that encode domain knowledge for repeatable AI-assisted tasks
• Demonstrated ability to listen to non-technical subject matter experts, identify the underlying process or bottleneck, and design a practical AI-assisted or automated solution—prior experience in operations, process improvement, or business analysis roles is a strong differentiator
• Experience building dashboards in tools such as Power BI, Tableau, or similar platforms, with the ability to define KPIs in partnership with stakeholders and translate them into clear, actionable visualizations
• Prior involvement supporting IT systems in an operations or business context—including configuration, user support, and vendor coordination for platforms such as CLM tools, contract repositories, workflow automation systems, or collaboration platforms; pharmaceutical/biotech industry experience a plus

Knowledge/Skills:

• Proficiency with Claude (Anthropic), including experience writing and structuring SKILL.md files, system prompts, or structured context documents that reliably shape AI outputs for specific operational use cases
• Strong analytical and problem-solving skills; comfortable moving between ambiguous, high-level concepts and the precise, structured thinking required to encode those concepts into reliable AI workflows
• Familiarity with Microsoft 365 ecosystem (SharePoint, Teams, Power Platform) and comfort working within enterprise IT environments and governance frameworks
• Ability to work in a fast-paced, team-based environment, managing multiple parallel workstreams across AI development, system support, and stakeholder collaboration
• Strong written and verbal communication skills; able to document technical configurations and AI workflows in plain language accessible to non-technical Operations staff
• Responds well to evolving priorities and ambiguous problem statements; brings structure and calm to fast-moving situations while maintaining quality and attention to detail

  ]]> Wed, 25 Mar 2026 00:00:00 EDT 0 Additional position details from the manager:

Can you please confirm your top 3 skills sets required?

1. Follow written guidance
   2. Willingness to learn and function on a team
   3. Some test experience, electrical testing a plus

Can you please confirm the 3 main responsibilities/day to day activities required for this role? Testing and Data Collection



The primary focus of this position will be Mechanical & Electrical testing of CRM and NEURO division’s products. This may include packaging testing, mechanical, and electrical testing of leads, pacemakers, defibrillators, loop recorders. Testing is focused on subjecting our devices to a wide variety of exposures (environmental, fatigue, implant procedures, electrical, electromagnetic) and ensuring designs are robust and meet specifications. Responsibilities may include the following and other duties may be assigned.

• Ensure conformance to test plans, work instructions, and industry standards for execution and use of drop, shock and vibe systems, environmental chambers, Instron, electrical test systems and equipment, multimeters, generators, oscilloscopes, etc.
• Prepare, set up, troubleshoot, and utilize test instrumentation and complex test set-ups.
• Plan test schedules to manage priorities, maximize equipment run time, and technician time.
• Communicate with management and customers on the estimated start date, status of work in progress, issues, observations, potential disruptions, and competing priorities.
• Work effectively and efficiently in a team environment and as an individual.
• Lead and collaborate on projects, including performing complex tests and providing updates to the broader teams and/or customers.
• Proficiency with computer skills, Microsoft Word and Excel for data collection and documenting processes.
• Proficient in adhering to industry, company, and department policies.
• Ability to read and follow all processes related to testing.
• Good communication, interpersonal and technical writing skills; communicate and document results clearly and accurately.
• Participate in internal and external audits.
• Work is 100% onsite in facility located in Fridley, MN
• On rare occasions, perform offsite testing which may occur overnight or weekends.
• HS Diploma/GED required

Ideal Candidate will:

•  2+ years testing background on medical devices a plus but not required
•  Completed vocational or technical education
•  Motivated to learn, work, and be part of a high functioning team
•   Work as a team member and support multiple projects and responsibilities
•   Pay close adherence to work instructions, policies, procedures, and good documentation practices
•   Knowledge of FDA regulations and ISO/IEC 17025, as well as working in a regulated environment
•   Mechanical, Electrical, and EMC testing experience
•   Demonstrate safe work practices, for example ICD handling and high voltage tests
•   Solder and assembly experience
•   Familiar with calibration and metrology services and support
•   Working knowledge of Test Method Validations / Install Qualifications

]]> Wed, 25 Mar 2026 00:00:00 EDT 1 Quality Technician

Join our team as a Quality Technician and play a vital role in ensuring the highest standards of quality and safety in a dynamic, fast-paced environment. This is an exciting opportunity for detail-oriented professionals eager to contribute to a forward-thinking organization committed to excellence and continuous improvement. If you’re passionate about quality assurance and eager to grow your career, we want to hear from you!

What You’ll Do:

• Conduct inspections and tests on products to verify quality standards are met.
• Document findings accurately and report any deviations or issues.
• Collaborate with cross-functional teams to resolve quality concerns.
• Maintain a safe and efficient work environment, adhering to company and industry standards.
• Support continuous improvement initiatives to enhance product quality and process efficiency.

Required Skills:

• Strong attention to detail and excellent observational skills.
• Basic understanding of quality testing procedures and inspection techniques.
• Good organizational and communication skills.
• Ability to work effectively both independently and as part of a team.
• Comfortable working in a rotating shift environment.

Nice to Have Skills:

• Previous experience in a quality control or technician role.
• Familiarity with industry-specific standards and certifications.
• Basic knowledge of manufacturing or production processes.
• Proficiency in using measurement and testing equipment.

Preferred Education and Experience:

• High school diploma or equivalent required.
• Previous experience in a quality assurance or manufacturing environment is advantageous.

Other Requirements:

• Ability to work on-site in Newport.
• Must be comfortable working in a rotating shift schedule, including early and late shifts.
• Compliance with safety and company policies.

Ready to bring your quality expertise to an innovative team? Take the next step in your career and apply now to become our next Quality Technician I in Newport!
]]> Wed, 25 Mar 2026 00:00:00 EDT 1
PRIMARY DUTIES 1. Initiates and completes customary procedures in an efficient manner; operates and is responsible for lab equipment.
2. Demonstrates technical ability to independently performs routine laboratory experiments and procedures following appropriate training and established protocols. Routine assays include but are not limited to basic bacterial culture, ELISA, Luminex and PCR.
3. Understands and applies basic scientific principles with guidance.
4. Reports and treats data with a high level of integrity and ethics.
5. Complies with applicable regulations, performing all work in a safe manner; Maintains proper records in accordance with SOPs and policies.
Skills:     Previous scientific/laboratory experience preferred. Education:     Bachelor’s Degree in relevant scientific discipline or equivalent experience in a related field.




 
Pay Rate Range: $20-24/hr depending on experience  ]]> Wed, 25 Mar 2026 00:00:00 EDT 1
Position: Mobile Research Nurse
Job Description: As a Mobile Research Nurse, you will play a crucial role in ensuring the successful execution of research studies. You will be responsible for administering investigational medications/products, conducting patient assessments, collecting vital information, and adhering to study protocols with utmost accuracy and ethics. Your expertise and caring nature will help us maintain compliance with each study's protocol and safeguard the well-being of study patients. Principal Duties and Responsibilities:

• Accountable for the competent and confident delivery of high-quality clinical care to patients/participants. Ensure compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.
• Administer investigational medications/products as needed; Perform patient assessments to determine presence of side effects; notify Principal Investigator of findings/issues.
• Perform medical tests as outlined in protocol, including, but not limited to: vital signs, specimen collection, electrocardiograms; Process specimens and ship specimens per protocol.
• Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
• Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations.
• Communicate effectively, promoting open and trusting relationships.

Qualifications:

• Relevant Nurse Licensure
• CH-GCP Certificate
• Graduate from an accredited BSN or Associate Degree in Nursing or Nursing Diploma
• program
• Minimum 2 years’ post qualification acute care experience
• Clinical Research experience desirable
• BLS certification required
• Experience and knowledge of working in clinical research trials with ICH-GCP (Good
• Clinical Practice) Certification - (Training can be provided)
• Good basic IT skills, utilizing mobile devices and Microsoft systems
• Trained in Handling and Transport of Hazardous Substances (training can be provided)
• A flexible schedule is essential
• Unencumbered driver’s license, reliable car

Benefits:

• Competitive pay rates with hourly compensation for travel time and patient interactions.
• Mileage reimbursement for travel expenses.
• Flexible working shifts to accommodate work-life balance.
• Project-specific training provided to enhance your skills in clinical research.
• Ongoing training and line management support for professional growth.

 ]]> Wed, 25 Mar 2026 00:00:00 EDT 0
Summary:
The main function of a maintenance technician is to perform work involving the skills of two or more maintenance or craft occupations to keep machines, mechanical equipment, or the structure of an establishment in repair.

Job Responsibilities:
• Repair or replace defective equipment parts, using hand tools and power tools, and reassemble equipment.
• Perform routine preventive maintenance to ensure that machines continue to run smoothly, building systems operate efficiently, or the physical condition of buildings does not deteriorate.
• Inspect drives, motors, and belts, check fluid levels, replace filters, or perform other maintenance actions, following checklists.
• Use tools ranging from common hand and power tools, such as hammers, hoists, saws, drills, and wrenches, to precision measuring instruments and electrical and electronic testing devices.
• Assemble, install or repair wiring, electrical and electronic components, pipe systems and plumbing, machinery, and equipment.
• Inspect, operate, and test machinery and equipment to diagnose machine malfunctions.
• Record type and cost of maintenance or repair work.
• Clean and lubricate shafts, bearings, gears, and other parts of machinery.
• Dismantle devices to access and remove defective parts, using hoists, cranes, hand tools, and power tools.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Basic knowledge of machines and tools, including their designs, uses, repair, and maintenance.
• Basic knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• Basic knowledge of the practical application of engineering science and technology.

Education/Experience:
• High school diploma or GED required.
• 2-4 years experience required.]]> Wed, 25 Mar 2026 00:00:00 EDT 1 The Research Strategy, Innovation & Portfolio Management group is seeking a talented and highly motivated project manager to manage coordination and progression of scientific research projects in a highly collaborative environment and cross-functional matrix. The candidate will efficiently interact with multiple stakeholders representing multiple functions within the company to drive research projects forward to clinical development.

Essential Responsibilities
• Responsible for starting up or managing the research-based development subteams.
• May help manage teams that are preparing to present their molecule at governance meeting for clinical development.
• Experience working effectively with cross-functional project teams to build and develop the team, diagnose team health and taking action to address team issues.
• Ability to organize new cross-functional project teams, define objectives and scope, identify tasks and milestones, build project schedules, identify resource needs, track execution to schedule, and manage risks.
• Experience and ability in successfully managing multiple cross-functional tasks simultaneously.

Knowledge, Experience and Skills:
• Bachelors degree with 7+ years, MS degree with 5+ years of relevant experience, which includes experience in the pharmaceutical industry as a functional area scientist or project manager.
• Direct experience or strong foundation in drug development process is preferred.
• Experience should include participation in cross-functional project team activities.
• Self-motivated, resourceful, high technical competence and process-oriented.
• Clear and effective communication.
• Ability to work both collaboratively and independently.
• Strong proficiency with Microsoft Office tools (Outlook, Excel, PowerPoint, Word, and Teams) and Zoom.
• Must be on site at Foster City office at least 3 days per week

Pay Range: 68-73/hr based on experience ]]> Wed, 25 Mar 2026 00:00:00 EDT 1 Can you please confirm your top 3 skills sets required?

• At least 3 years of experience with ISO 14971 in a medical device company
• At least 3 years of experience creating or maintaining risk management files for medical devices
• At least 3 years of experience working with Quality Design Control deliverables

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

• Updating and Maintaining Risk Management Files for Class III Medical Devices
• Working with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.
• Collaborating with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.

What products (if any) will this role support?

• Spinal Chord Stimulation, Deep Brain Stimulation, Pelvic Health

What is your target years of experience?

• At least 5 years of experience within Medical Device

When do you plan to start interviewing?

• As soon as possible

Will you be looking to hire and start ASAP or will the start date be delayed? 

• Targeted starting date: May 4, 2026. 

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?

• 4 days a week onsite and 1 day remote

____________________________________________________________________________________________

We are currently looking for a  Sr  Risk Engineer to work within the Neuromodulation and Pelvic Health to drive the and support risk management sustaining activities. 

Location: This position will be a an onsite role  in Fridley, Minnesota with the benefit of working remotely on Fridays.

In this critical role as Sr. Risk Management Engineer, you will work closely with multidisciplinary project teams to create, and remediate risk management documents that meet ISO 14971 . This role is people oriented, requiring excellent collaboration and communication skills; it also requires persnickety attention to detail.

 Responsibilities may include but are not limited to:

·        Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis.

·        Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted.

·         Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated.

·         Evaluate impact of potential issues to patient safety and product performance

·         Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.

·         Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle.

·         Identify and act upon opportunities for continuous improvement of the Risk Management Process

·         Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance.

·         Create documentation in compliance with applicable procedures to meet project deliverables.

Qualifications 

Experience with implantable medical devices.

Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., Product Hazard Analysis, Design and Process FMEA, User Analysis).

Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA).

Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering.

Experience in the application of statistics.

Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work.

Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively.

Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.
]]> Wed, 25 Mar 2026 00:00:00 EDT 1 *depending on experience

Main Purpose:
US site security officers assigned to site uniform patrol or static posts are responsible for proactive safe guarding of site properties and for the proper handling of calls for security services. Security Officers may serve as liaison with police or other law enforcement agencies on mutual problems, respond to fire alarms and assist in the evacuation of employees in emergency situations. Security officers will prepare clear and accurate computer generated reports of incidents and other activities and ensure protection of employees, physical assets, intellectual properties and information assets.

Scope (global, regional, or local): Local

Key Working Relations (Internal/External):
1. Internal Employees, contractors, visitors, and guests across all business units
2. External local law enforcement, emergency services personnel, utility personnel, and security support vendors
3. Collaborate with and train site employees and security personnel while recommending security implementation upgrades and policies
4. Develop reporting mechanisms while strategically collaborating with internal stakeholders to ensure security policies/procedures are implemented and incidents are reported appropriately and timely to Corporate Security Management
7. Participate or lead programs, trainings, workshops, security know how campaigns and the implementation of directives that enhance the personal security of employees within their workplace

Key Tasks:
1. Performing mobile patrol of site within geography of responsibility on roadways and parking lots
2. Protecting sites from trespassers or illegal entry
3. Protecting against damage or theft of company property
4. Investigating and respond to calls for service
5. Providing emergency services and rescue, CPR and first aid during sudden illnesses or injury
6. Responding to intrusion and equipment alarms
7. Conduct initial investigations of accidents, or crimes against company property or employees
8. Fostering an environment of trust and confidence through exemplary integrity and professionalism
9. Preparing appropriate report documentation
10. Ability to think independently, react to changing conditions and be able to make sound decisions based upon existing circumstances
11. In the event of an emergency, maintaining order and the safety of employees and visitors

Qualification & Competencies:
1. Bachelor's degree is preferred; High School diploma or equivalent required
2. Law enforcement, military and/or corporate security experience is required
3. The ability to work autonomously and with limited supervision
4. Excellent interpersonal and communication skills
5. The ability to prepare clear, succinct, accurate, professional and timely written communications
6. The ability to maintain all certifications and training as required by jurisdiction of authority and possess a valid driver's license
7. The ability to obtain and maintain the State of Hawaii "Guard Card" according to the State of Hawaii HRS 463 10.5
8. Experienced in basic computer skills
9. Able to work rotating shifts and available for overtime and weekend shifts
10. The ability to work in excess of the normal eight hour day when necessary]]> Wed, 25 Mar 2026 00:00:00 EDT 1 • Assist participants with porting their mobile phones to the required platform
• Configure and pair Apple Watch devices with participant mobile phones
• Ensure proper installation of required applications and system settings
• Verify device connectivity, data synchronization, and functionality
• Troubleshoot basic technical issues related to mobile devices and wearables
• Provide clear instructions and guidance to participants on device use
• Document setup completion and any technical issues encountered
• Maintain compliance with data privacy, security, and study protocols
Education and Experience: • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’) or equivalent combination of education, training, & experience.
• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities: • Experience supporting clinical research or healthcare technology environments
• Familiarity with mobile device management (MDM) systems
• Experience working in participant-facing or customer support roles
• Ability to communicate information effectively
• Ability to troubleshoot and resolve issues on mobile phones and watches
• Strong customer service skills
• Ability to multi-task and pay close attention to detail
• Analytical and problem-solving skills



Pay Rate Range: $29.70 - $33 depending on experience ]]> Wed, 25 Mar 2026 00:00:00 EDT 1
The Associate Scientist I will work closely with senior scientists and engineers to execute laboratory operations, collect and document data, and support process optimization and technology transfer activities.

This position is onsite and located in Cambridge, MA.

Key Responsibilities

• Support process development, optimization, and scale-up of bioconjuagtion processes.
• Support oligonucleotide synthesis method development, optimization and scale-up
• Execute laboratory-scale processes to support research and in-house material needs
• Perform routine in-process analytical tests (e.g., pH, conductivity, UV, basic chromatography)
• Assist in process development for novel chemistries
• Operate laboratory and analytical equipment after appropriate training
• Accurately document experimental work following good documentation practices (GDP)
• Collaborate with cross-functional teams including Process Development, Analytical Sciences, and Manufacturing
• Maintain a safe, organized, and compliant laboratory workspace

Qualifications

• BS in Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline.
• 0–2 years of laboratory experience (academic, co-op, internship, or industrial experience acceptable).
• Oligonucleotide experience required.
• Experiece with Bioconjugation, anitbodies, and peptides highly preferred.
• Familiarity with analytical techniques such as pH, conductivity, HPLC, or LC-MS is preferred.
• Strong attention to detail and commitment to high-quality laboratory documentation
• Willingness to learn regulated laboratory practices and manufacturing workflows
• Ability to work collaboratively, follow instructions, and manage time effectively
• Microsoft Office Suite experience.

]]> Wed, 25 Mar 2026 00:00:00 EDT 1 The Opportunity:  Clinical Pharmacology QC Lead

We are seeking an experienced Temporary Clinical Pharmacology QC Lead to support quality control review of clinical pharmacology submission documents and regulatory responses for oncology programs in late-stage development. This role will ensure scientific accuracy, cross-document consistency and high-quality submission-ready documentation aligned with regulatory expectations and internal standards, supporting timely responses to regulatory agencies.


Required Skills, Experience and Education:

• Advanced degree (MS, Pharm D, Ph.D, MD or equivalent) in life sciences, pharmacy or related field.
• Strong experience in NDA submissions, Clinical Pharmacology and/or clinical documents.
• Demonstrated expertise in QC of regulatory documents
• Strong understanding of ICH guidelines, CTD format and FDA/EMA regulatory processes.
• Excellent attention to detail and ability to work under tight timelines.
• Strong cross-functional communication and issue resolution skills.

Preferred Skills:

• Oncology drug development experience
• Experience supporting FDA information requests

Duration & Commitment:

• Contract position 6 months+
• Remote flexibility possible but candidates will be working onsite at HQ in Redwood City

]]> Wed, 25 Mar 2026 00:00:00 EDT 0 Werden Sie Teil eines international führenden Medizintechnikunternehmens und übernehmen Sie eine Schlüsselrolle beim Ausbau innovativer klinischer Lösungen. In dieser Position verantworten Sie den gesamten Vertriebsprozess in Ihrem Gebiet – von der Identifikation neuer Chancen bis zur erfolgreichen Implementierung im klinischen Umfeld.
Ihre Aufgaben

• Verantwortung für Akquise, Weiterentwicklung und Umsetzung von Lösungen in den Bereichen Medikamentenapplikation, Hautantiseptik sowie Sicherheitslösungen für gefährliche Substanzen.
• Durchführung technischer, klinischer und kaufmännischer Gespräche in Krankenhäusern und spezialisierten Einrichtungen zur Erreichung definierter Vertriebsziele.
• Nutzung Ihrer Marktkenntnisse in Onkologie, Radiologie und pharmazeutischer Zubereitung zur Identifikation neuer Geschäftsmöglichkeiten.
• Aufbau und Pflege enger Beziehungen zu Ärztinnen und Ärzten, Pflegekräften, Apothekerinnen und Apothekern, Hygienefachpersonen sowie Einkaufsteams.
• Etablierung eines Netzwerks aus regionalen und überregionalen Key Opinion Leaders.
• Unterstützung von Produkteinführungen sowie Begleitung anwendungsspezifischer Abläufe im OP?Umfeld.
• Aktive Teilnahme an Testphasen, Implementierungen, Workshops, Messen und Fachveranstaltungen.
• Strukturierte Steuerung von Vertriebschancen auf Basis eines kundenzentrierten Ansatzes.
• Transparente Dokumentation aller Aktivitäten im CRM sowie Nutzung mobiler Tools zur Analyse und Planung.
• Eigenständige Organisation Ihrer Reisetätigkeit (ca. 80 %, inkl. Übernachtungen).

Ihr Profil

• Abgeschlossene Ausbildung im Rettungsdienst (z.?B. Notfallsanitäter/in, Rettungsassistent/in) und mehrere Jahre relevante Berufserfahrung.
• Idealerweise mindestens 2 Jahre Vertriebserfahrung oder Erfahrung in der klinischen Positionierung von Medizintechnik? oder Diagnostiklösungen.
• Kontaktstark, kommunikationssicher und überzeugend auf allen Hierarchieebenen.
• Routine in der Unterstützung klinischer Anwendungen im OP.
• Hohe Präsentationssicherheit und die Fähigkeit, komplexe Inhalte verständlich zu vermitteln.
• Eigenverantwortliche, lösungsorientierte und motivierte Arbeitsweise.
• Teamorientiertes Auftreten und Freude an gemeinsamer Zusammenarbeit.
• Hohe Reisebereitschaft sowie strukturierte Planung Ihrer Touren.
• Sehr gute Deutschkenntnisse in Wort und Schrift sowie gute Englischkenntnisse.
• Ausgeprägte Lernbereitschaft und eine offene, hands?on geprägte Mentalität.

]]> Tue, 24 Mar 2026 00:00:00 EDT 1 Conducts multiple ongoing clinical trials involving patients or healthy volunteers/subjects. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, and retention of study participants.

Essential Functions: • Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, always ensuring patient safety comes first.
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
Knowledge, Skills and Abilities: • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment



  Pay Rate Range: $40-44/hr depending on experience  ]]> Tue, 24 Mar 2026 00:00:00 EDT 1
Job Purpose
Keep assigned lines supplied with bulk products and components. Perform various filling and packaging operations.

Major Accountabilities
• Supplies production line with product and packaging components as required.
• Loads and unloads components or product onto or from pallets, trays, racks, shelves and machines manually.
• Load components on machines and monitors operations to detect malfunctions.
• Attaches pumps and hoses into hopper connections as required.
• Assures all perimeter shippers are labeled prior to leaving the production floor.
• Scrapes hoppers, assures hoppers stay filled during production run.
• Assist with cleaning equipment as needed for efficient and proper line clearance.
• Transfers materials and/or products to or from storage or work sites to designated area by manual or power floor jack, dolly or other device.
• Assemble shippers, removes trash, product waste from packaging area.
• Cleans and sanitizes work areas using broom, wipes, mop, or cleaning machine, (i.e. gowning area, packaging floor perimeter and fill rooms).
• Weighs or counts product for disposal, documents weight and disposes accordingly.
• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency.
• Maintain effective communication between shifts.
• Perform Packaging Pharma Operator duties as necessary.
• Maintains supply of PPE (i.e. gloves, sleeves, dust masks) isopropyl alcohol (IPA) and wipes on packaging lines.
• Work with equipment such as ladders, manual floor jack, dollies, and be able to service multiple packaging lines simultaneously.
• Alerts Supervision, Mechanics and Quality personnel of safety, quality and equipment performance problems when they occur.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee must be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

Key Performance Indicators
• Solid English reading/comprehension written and verbal communication skills required to understand and communicate to others detailed cGMPs, SOP's, FI’s, and production equipment cleaning instructions.
• Basic mathematical skills and ability to work with numbers to accurately count components, waste and finished goods products.
• Support and implement safety initiatives, wearing all personal protective equipment (PPE), and displaying safe work performance according to company standards.
• Perform key roles in a manner that motivates personnel, promotes teamwork, is respectful of others while remaining aligned with company’s behaviour expectations.
• Takes initiative and works autonomously to meet production requirements.
• Continues to develop and learn new skills, which will allow for further advancement within the organization.

Job Dimensions
Number of associates:
0
Impact on the organization: Medium

Ideal Background
Education: • High School Diploma or GED. Associates Degree preferred. Equivalent experience can be considered in lieu of HS Diploma
• Minimum of one year production experience
Experience: • Ability to lift 50 lbs. and maintain a high level of physical activity]]> Tue, 24 Mar 2026 00:00:00 EDT 1 *depending on experience

Job Description Summary:

Objective of the MEP Engineer - Capital Projects

To ensure that all installations and functional implementations meet the intended design, performance expectations, and regulatory standards by systematically reviewing, verifying, and documenting compliance.
• Inspect all electrical equipment installations and wiring methods to validate compliance with the approved designs, URS requirements, vendor specifications and local Code regulations
• Review instrument calibration certificates and loop testing documentation.
• Review instrument air systems, tubing runs, and junction box installations.
• Assess design documents, technical drawings, layout plans, and equipment documentation for alignment with URS and delivery specifications.
• Review electrical equipment grounding, bonding, and safety disconnect systems for compliance with the approved drawings.
• Review motor control centers, variable frequency drives, and power distribution
components.
• Document electrical construction progress and all quality field observations.
• Document any deviations or non-conformities with clear evidence.
• Inspect emergency power systems including generators and uninterrupted power supplies.
• Review electrical documentation to confirm process and product compliance.
• Inspect damaged materials.
• Review electrical as-built documentation
• Schedule on-site inspections as applicable.
• Witness electrical testing (e.g., FAT, SAT, mock-ups) and report findings.
• Review & inspect all mechanical components to confirm compliance with the approved designs, URS requirements, vendor specifications and local Code regulations.
• Review special need items.
• Document mechanical construction progress and all quality field observations.
• Inspect damaged materials.
• Schedule on-site inspections as applicable.
• Review mechanical documentation to confirm process and product compliance.
• Witness mechanical testing (e.g., FAT, SAT, mock-ups) and report findings.
• Review mechanical as-built documentation.
• Attend project meetings as required.
• Collaborate with engineering, quality assurance, construction partners, and suppliers to clarify requirements and resolve issues efficiently.
• Update earned credit report and forward to project stakeholder(s) at a regular interval.
• Provide timely feedback on inspection findings to ensure corrective actions are initiated and completed.]]> Tue, 24 Mar 2026 00:00:00 EDT 1
Make a meaningful difference to patients around the world. At Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:
•    Optimizing manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills. 
•    Developing moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports. 
•    Analyzing and resolving moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
•    Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
•    Establishing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
•    Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work
•    Collaborating across sites and cross functional teams (R&D and commercial).
•    Coordinating manufacturing builds and raw material allocations. 
•    Leading process validations (IQ, OQ, PQ).
•    Supporting documentation for the team.
•    
What you’ll need (Required):
•    A Bachelor's degree in Engineering or Scientific field with 2 years of previously related industry experience OR Master’s degree in Engineering or Scientific field Required.  
•    

What else we look for (Preferred): 
•    Good computer skills in usage of MS Office Suite including MS Project; 
•    Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
•    Strong Organizations skills with the ability to manage complex projects/tasks
•    Good adaptability in changing projects, directions, and priorities
•    Good time management skills to ensure timely completion of tasks
•    Ability to drive tasks with minimal supervision; self-starter
•    Basic understanding of statistical techniques
•    Previous experience working with lab/industrial equipment preferred 
•    Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
•    Solid problem-solving, organizational, analytical and critical thinking skills
•    Solid understanding of processes and equipment used in assigned work
•    Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
•    Knowledge of applicable FDA regulations for medical device industry
•    Strict attention to detail
•    Ability to interact professionally with all organizational levels
•    Ability to manage competing priorities in a fast-paced environment
•    Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
•    Ability to build productive internal/external working relationships
•    Understanding of Phase-gate product development
•    Medical device or regulated industry experience
•    Understanding of design requirements documentation, risk management plans, inspection criteria, test method development and validation activities 
•    Cleanroom environment experience
•    Knowledge of manufacturing line design
•    Knowledge of process creation and process improvement
•    Knowledge of process and design transfer activities
•    Understanding/knowledge of Design for Manufacturing (DFM) principles]]> Tue, 24 Mar 2026 00:00:00 EDT 1 The Business Application Manager is responsible for the assigned application (CTMS) that directly or indirectly supports the management, set-up, conduct, analysis and/or reporting of Clinical Trials for Clinical Operations Chapter area.

Key Accountabilities:
- Provide implementation and operational management support for the software application
- Works independently to accomplish his/her responsibilities related to the assigned application(s)
- Partner with internal and external stakeholders to improve business application capability and processes supported by the application
- Clearly and effectively communicate application modifications, changed processes and problem-solving results to affected groups and leadership
- Responsible to thoroughly investigate reported incidents that involve applications abnormalities, failures or defects by leveraging technical/business expertise
- Recommends/Implements technical and procedural improvements to ensure effective use of application
- Promptly respond to urgent technical issues regarding system failures and escalate as necessary
- Assist in development of training content, guides and associated documentation, that helps onboard the users on the assist application(s)
- Participates in cross-functional groups focused on improving/maintaining high data quality in the assigned application(s)
- Partner with IT counterpart to maintain oversight of the business application(s) backlog, including specification/requirement management, acceptance testing, validation, documentation, data classification/security and user management (if applicable)
- Train and support CDMA/Clinical Operations employees in technical use and troubleshooting of the e-Solution, reports and monitoring activities

Requirements:
- Minimum Bachelors or advanced degree in Computer Science, Information Systems or related field or equivalent combination of education and work-related experience in the clinical trial field
- At Least 7 years of business/ system analysis/ analytical experience
- Comprehensive experience analyzing and solving business situations
- Ability to communicate difficult concepts and negotiates with others to adopt a different point of view
- Excellent organizational, communication, and demonstrated expert data management skills including working knowledge of cross-functional areas
- In-depth understanding of Agile methodology
- Experience with Diagnostics and/or Pharmaceutical Information Systems is a plus
- Prior CTMS experience is preferred.
- A comprehensive understanding of the clinical development process is a plus

Pay ranges between 45-50/hr based on experience ]]> Tue, 24 Mar 2026 00:00:00 EDT 1
Site: South East East UK
Type: Contract - shifts
Onsite: 100% onsite presence

Looking for a hands-on role where your logistics skills can make a real impact? As a Warehouse Specialist at a leading organization committed to revolutionizing medicine through innovative technology, you'll be a vital part of our cutting-edge efforts. This site-based position offers the chance to work within a dynamic, fast-paced environment supporting 24/7 drug manufacturing.
You'll handle everything from inbound deliveries to inventory management, ensuring materials flow smoothly to keep production on track. Plus, you'll gain valuable experience working with digital tools like SAP and our Quality Management Systems—perfect for building a future in automation and innovation.
What You’ll Need:

• 2+ years in warehouse or logistics roles
• Experience in GMP or GDP environments
• Knowledge of Quality Management Systems
• Proficiency with Microsoft Office, SAP, and Smartsheet is a plus
• Ability to lift safely and adapt to operational needs
• Attention to detail and a proactive attitude

Nice to Have:

• Background in pharmaceuticals or life sciences
• Experience in regulated industries

Preferred Education & Experience:

• High standard educational background
• Solid hands-on experience in regulated logistics

Other Requirements:

• Flexibility to work on a rotating schedule, including 12-hour shifts

If you're ready to be part of a pioneering organization shaping future healthcare, don’t wait—apply today and help us make a difference!

 ]]> Tue, 24 Mar 2026 00:00:00 EDT 1 The Project Manager (PM) supports Global Program Managers by contributing to the maintenance of project documentation, including timelines, meeting materials, and risk registers. This role is primarily focused on operational coordination, tracking project deliverables, and facilitating execution activities under the direction of senior program leadership.

Job Responsibilities
•Monitor and communicate progress on project deliverables, key milestones, and potential risks.
•Support the creation and maintenance of project documentation, including schedules, meeting summaries, and action item trackers.
•Organize and facilitate team meetings, develop agendas, and ensure follow-up on assigned actions.
•Manage SharePoint access for project teams.
•Partner with functional leads to drive timely execution of tasks and deliverables.
•Identify and escalate issues and risks to senior program managers.
•Update and maintain functional plans utilizing Planisware.
•Maintain accuracy and currency of project management systems and tools.
•    May support Development organization process improvement work streams.

Basic Requirements 
•Bachelor’s degree in life sciences, business or related discipline, and 3+ years of pharmaceutical/biotech experience

Preferred Qualifications 
•Proven experience in project management or operational roles within the pharmaceutical or biotechnology sectors.
•Solid understanding of drug development processes and team collaboration dynamics.
•Exceptional organizational and communication abilities.
•Strong analytical and problem-solving skills, with a keen eye for detail and a proactive approach to troubleshooting.
•Excellent interpersonal, written, and verbal communication skills, with the ability to collaborate effectively and influence outcomes without direct authority.
•Background in oncology or cell therapy is a plus, though not required.
•Experience working with enterprise planning tools; familiarity with Planisware is preferred.
•Experience with SharePoint.

6+ years of relevant experience and a BA or BS or; 4+ years of relevant experience and a MS or MBA Relevant experience consists of work in a scientific field or equivalent experience in association with R&D project teams and/or in cross-functional project management activities.

Pay ranges between 58-63/hr based on experience ]]> Tue, 24 Mar 2026 00:00:00 EDT 1
IDEAL QUALIFICATIONS:
• Drug Substance Bioprocessing background required.
• 2+ years Prior experience in process development/ /Process Engineering environment, clinical or commercial scale manufacturing, or tech transfer, with specific experience in the implementation, scale up, and support of biopharmaceutical manufacturing processes.
• Experience leading or supporting process optimization/ continuous improvement projects
• Some understanding of regulatory and cGMP requirements.
• Experience with project management. Has the ability to manage projects independently, break down high level projects into smaller incremental tasks, and elevate relevant issues to project lead and line management.
• Some experience with digital tools and/or data visualization software (e.g. Tableau, Spotfire, Smartsheet, Sharepoint, AI tools).
• Excellent written and verbal communication.
• Able to adapt to changing business needs and operational requirements.
• Experience with issue resolution and ability to influence across support organizations.
• Bachelors degree (Chemical Engineering, Bioengineering or Biotechnology, computer science, or other quantitative discipline)

IDEAL BEHAVIORS:
• Enjoys tackling challenges, working in teams, and excels at organizing information from numerous sources to provide well-constructed deliverables.
• High attention to detail and quality in work.
• Ability to collaborate well cross-functionally between departments and work closely with team members to accomplish larger tasks.
• Passion for proactively identifying opportunities and solutions through creative data analysis.
• Intellectual curiosity with ability to learn new concepts/frameworks and technology rapidly as needs arise.
• Ability to problem solve, conceptualize solutions independently, escalate issues appropriately, and integrate feedback.
• Ability to ask clarifying questions and seek guidance when necessary.
• Ability to manage multiple projects simultaneously and deliver results in a timely fashion.
• Accountable, Self starter, and quick learner

WORK MAY INCLUDE, BUT IS NOT LIMITED TO THE FOLLOWING:
• Optimization of business processes related to Drug Substance pharmaceutical manufacturing, such as technology transfer.
• Generate business process documentation such as Guidelines, job aids, templates, and Standard Operating Procedures (SOPs), with feedback from SMEs and management.
• Collaborate with partner organizations to develop and deploy digital business process solutions to facilitate knowledge management and business process execution.
• Support strategy development to identify tech transfer business process pain points and deploy solutions to improve processes.
• Collaborating with multiple stakeholders to understand project timelines, create a project plan, and execute the project deliverables in a timely fashion.
• Develop visualization dashboards to communicate OKRs, metrics, and process improvements. Deliver presentations to management and cross-functional partners.

*CO/NYC candidates might not be considered]]> Tue, 24 Mar 2026 00:00:00 EDT 1 Description:

Summary:
The main function of a DevOps Engineer is to build functional systems that improve software experience.
A typical DevOps engineer is responsible for deploying product updates, identifying and troubleshooting production issues as well as implementing integrations.

Job Responsibilities:

• Modify existing software to correct errors, allow it to adapt to new hardware, or to improve its performance.
• Implement integrations as requested by internal/external customers.
• Analyse user needs and software requirements to determine feasibility of design within time and cost constraints.
• Coordinate software system installation and monitor equipment functioning to ensure specifications are met.
• Design, develop and modify software systems, using scientific analysis and mathematical models to predict and measure outcome and consequences of design.
• Analyse information to determine, recommend, and plan computer specifications and layouts, and peripheral equipment modifications.
• Obtain and evaluate information on factors such as reporting formats required, costs, and security needs to determine hardware configuration.

Skills:

• Strong knowledge of DevOps practices.
• Verbal and written communication skills, problem solving skills, customer service and interpersonal skills.
• Ability to work independently and manage one’s time.
• Knowledge of computer hardware and software.
• Understanding of how various IT systems work.
• Knowledge of design techniques and principles involved in production of drawings and models.
• Experience with DevOps tools such as Puppet, Kubernetes, Jenkins or others.
• Assist in the design, implementation, and management of AWS infrastructure using EKS, ECS, API Gateway and other related technologies.
• Contribute to the automation of deployment processes using Terraform, CloudFormation, and scripting languages.
• Participate in the design, implementation, monitoring and alerting of systems and applications to ensure high availability and performance.
• Collaborate with development teams to integrate and deploy applications on AWS.
• Troubleshoot and resolve infrastructure and application deployment issues.
• Contribute to the development and maintenance of CI/CD pipelines.
• Implement best practices for security, scalability, and cost optimization in AWS.
• Document processes and configurations.
• Stay up to date with the latest AWS services and DevOps trends.

Qualifications

• Bachelor’s degree in computer science, Engineering, or a related field (or equivalent practical experience).
• Experience with the following technologies:
• Containerization technologies (e.g., Docker, EKS, Kubernetes).
• Infrastructure as code (IaC), specifically Terraform.
• Monitoring tools (e.g., CloudWatch, Prometheus, Grafana).
• Configuration management tools (e.g., Packer, Ansible).
• Relational database technology (e.g., SQL/PSQL).
• Experience with at least one scripting language (e.g., Python, Bash).
• CI/CD pipelines and related technologies.
• Linux operating systems.
• Strong problem-solving and analytical skills.
• Excellent communication and collaboration skills.
• A proactive attitude and a willingness to learn.

Pay Rate Range: $70-84/hr depending on experience  ]]> Tue, 24 Mar 2026 00:00:00 EDT 1 Duties

• Accurately picks (using RF gun), packs, stages, scales, and loads customer orders for external/internal movement and prepares all pertinent documentation.
• Monitors and maintains an adequate supply of operating supplies and informs Coach when supplies need to be ordered.
• Maintains / back fills their respective areas keeping the supplies available.
• Performs clean up and light maintenance duties to maintain a high standard of housekeeping.
• Drives housekeeping efforts in preparation of internal and external audits.
• Actively participates in and completes all company training programs for Work Instructions (WI), Standard Operating Procedures (SOP), Company Policies, and Safety programs demonstrating learned knowledge on a daily basis.
• Actively participates in all Company and Departmental meetings, Performance Centers, etc.
• Performs cycle counts on a daily basis for their assigned area using RF gun and assists in reconciling discrepancies with Inventory Control.

Skills

Required:

• Ability to learn and apply all relevant WIs, SOPs, and other regulatory requirements.
• Ability to read information and apply what was described in the reading material to situations which may contain several details or describe processes involving several steps.
• Ability to effectively communicate both verbally and in writing to peers and management.
• Must have reliable transportation as position requires working at warehousing facilities located at multiple sites.
• Ability to use computers to perform a variety of data-entry transactions, perform RF transactions and to retrieve information (procedures; safety, employment, and other information using a calculator.
• Demonstrated ability to perform basic math functions using a calculator (add, subtract, multiply, divide, rounding, etc.).
• Demonstrated high level of personal motivation and initiative and be able to work independently to complete daily tasks assigned.
• Ability to adapt and be flexible with daily work assignment changes as well as a continuously-improving work environment.
• Ability and willingness to maintain accurate and factual hard-copy and electronic records.
• Demonstrated ability and willingness to work and participate effectively in a team environment.
• Operate warehouse industrial material handling equipment as required including Pallet Jacks, Pallet Transfer, Shrink Bundler, Strapping Machines, Shrink Wrapper, Pallet Scales, Conveyor, etc.
• Ability and willingness to follow directions, as assigned by management, coaches, peers, or in written instructions.
• Attention to detail, safety, quality and customer requirements.

Preferred: Familiarity with MS Office products (specifically Word, Outlook, and Excel) and SAP or equivalent systems.

PHYSICAL DEMANDS

• Must regularly lift and/or move up to 20 pounds, frequently lift and/or move up to 40 pounds, and occasionally lift and/or move up to 60 pounds with assistance.

Education

• High School diploma or GED
• 2 years GMP warehouse experience

Pay Rate Range: $20-27/hr depending on experience ]]> Tue, 24 Mar 2026 00:00:00 EDT 1 *Depending on experience

Job Description
Our Senior Representatives will deliver excellent customer service to customers with elevated expectations! You will support our customers by instilling trust, driving results, and staying patient focused! The ability to change hats and work as a team and independently is essential to success. You are the first point of contact and will own the customer experience from start to finish. Each interaction will require the ability to follow our processes with speed and accuracy. A performance-based organization that rewards diligent workers.

This position includes but is not limited to the following:

Responsibilities:
• Use of case management system to manage customer contacts and order detail with razor sharp accuracy
• Proactively track, resolve, and escalate order or cases in alignment with service excellence standards
• Place and monitor orders via phone, fax, and email for hospital and sales rep customers
• Orders translate to new orders, Returns, Billing, Inventory adjustments, reconciliations, and FCAs/Recalls.
• Own it! Proactively communicate backorders, order status, product availability, and missed deliverables
• Resolve complex issues via root cause analysis investigation, proposal of resolution, and resolution implementation with limited intervention
• Prioritize high work volumes from phones, email, case management, and faxes
• Become a SME (Subject Matter Experts) who can coach and train others
• Systematically process and transact consignment conversions & reconciliations
• Perform basic data analysis and generate reports for Sales, Customers, and Consignment Team
• Process customer returns and coordinate with Inventory Teams to ensure product is received
• Complete customer credits following documentation guidelines under SOX key controls
• Communicate regularly with Supply Chain Planning for inventory availability
• Perform at a level to meet and sustain department metrics and expectations


Basic Requirements:
• H.S. Diploma is required
• Minimum of 4 years Customer Service Experience
• Excellent written and verbal communication, interpersonal and relationship building skills with focus on negotiating and persuasion
• Ability to work in a demanding environment
• Excellent Customer Service skills with ability to negotiate and resolve demanding situations
• Ability to build and maintain strong relationships across the organization to influence and achieve objectives
• Strong Time Management Skills with ability to prioritize competing objectives
• Must be able to work in a team environment with minimum supervision, this includes inter-departmental and cross-departmental business partners
• Demonstrates problem-solving and critical thinking skills
• Proficient in MS Office Suite
• Experience within an ERP software
• Ability to manage confidential information with discretion
• Strict attention to detail

Preferred Qualifications:
? Bachelor’s degree is preferred (BA/BS degree is necessary to promote within)
? Salesforce experience or CRM experience
? Proficient in JDE (ERP Software)]]> Mon, 23 Mar 2026 00:00:00 EDT 1 SUMMARY/JOB PURPOSE: Provides high-level administrative and coordination support to senior leaders in Business Development. A key focus of this role is managing complex, sensitive calendars and facilitating seamless scheduling across internal and external stakeholders—including confidential discussions and senior-level meetings.

Essential Duties And Responsibilities:

• Proactively manages complex, high-priority Outlook calendars for multiple senior leaders; schedules and coordinates internal and external meetings—including with outside partners and executives—with a strong emphasis on discretion, accuracy, and seamless execution for sensitive or confidential discussions
• Coordinates travel for assigned team members with company travel agency, manage air and hotel reservations, create itineraries
• Provides support for reimbursement requests and expense reports
• Manages office communications—fields and routes organizational phone calls, emails, and traditional mail
• Provides as-needed back-up support for other administrators 
• Potential to collaborate across departments to help plan events and further company initiatives

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:

• Bachelor’s degree (B.A./B.S.) from four-year college or university preferred and a minimum of three years of related experience; or equivalent combination of education and experience 

Experience/The Ideal for Successful Entry into Job:

• Prior experience supporting Business Development, corporate strategy, investment banking, legal, consulting, or other teams where calendar coordination involves confidential or time-sensitive external discussions; pharmaceutical/biotech industry experience a plus but not required
• Demonstrated expertise in complex calendar management across multiple time zones and stakeholder groups; experience coordinating meetings that require significant pre-scheduling coordination, confidentiality, and back-and-forth with external parties (e.g., partner companies, investors, or counterparts in deal-sensitive contexts); additional administrative experience in travel, expense reporting, logistics, and communications

Knowledge/Skills:

• Advanced computer skills including advanced knowledge of Microsoft Outlook, Microsoft Word, Microsoft Excel, PowerPoint, and adept at Internet research
• Ability to demonstrate independent judgment, initiative, and common sense in problem-solving and making recommendations
• Strong interpersonal, oral and written communication skills
• Ability to work in a fast paced and team-based environment and manage multiple priorities.
•  Ability to build and maintain strong relationships.
• Demonstrates tact, diplomacy, respect, and confidentiality, is approachable and interacts professionally; builds business relationships based on mutual respect.
• Works efficiently, responds promptly
• Responds well to changing demands and frustrating situations by maintaining flexibility and professionalism

  ]]> Mon, 23 Mar 2026 00:00:00 EDT 0
Summary:
The main function of a buyer is to purchase machinery, equipment, tools, parts, supplies or services necessary for the operation of an establishment. A typical buyer is responsible for buying goods and services for use by their company or organization. A purchasing agent is responsible for the purchase of machinery, equipment, parts, or services necessary for the operation of an establishment.

Job Responsibilities:
• Review and potentially optimize suppliers based on price, quality, selection, service, support, availability and other relevant factors.
• Approve purchases of the highest quality merchandise at the lowest possible price and in correct amounts.
• Approve purchase orders, solicit bid proposals, and review requisitions for goods and services.
• Instruct staff on how to resolve problems related to undelivered goods.
• Instruct staff on methods of negotiation, renegotiation and administration of contracts with suppliers, vendors and other representatives.
• Confer with staff, users, and vendors to discuss defective or unacceptable goods or services and determine corrective action.
• Evaluate and monitor contract performance to ensure compliance with contractual obligations and to determine need for changes.
• Manage just-in-time inventory.
• Attend trade shows.

Skills:
• Verbal and written communication skills, attention to detail, negotiation skills and interpersonal skills.
• Ability to analyze financial reports, price proposals and other technical data.
• Ability to accurately document and record customer/client information.
• Basic mentoring skills necessary to provide support and constructive performance feedback.
• Ability to evaluate suppliers.
• Knowledge of applicable laws and regulations related to purchasing.
• Knowledge of supply chain management.
• Previous experience with computer applications, such as Microsoft Word and Excel.

Education/Experience:
• Bachelor's degree in finance or a related business field required.
• 5-7 years finance related experience required.]]> Mon, 23 Mar 2026 00:00:00 EDT 1
Job Purpose
Keep assigned lines supplied with bulk products and components. Perform various filling and packaging operations.

Major Accountabilities
• Supplies production line with product and packaging components as required.
• Loads and unloads components or product onto or from pallets, trays, racks, shelves and machines manually.
• Load components on machines and monitors operations to detect malfunctions.
• Attaches pumps and hoses into hopper connections as required.
• Assures all perimeter shippers are labeled prior to leaving the production floor.
• Scrapes hoppers, assures hoppers stay filled during production run.
• Assist with cleaning equipment as needed for efficient and proper line clearance.
• Transfers materials and/or products to or from storage or work sites to designated area by manual or power floor jack, dolly or other device.
• Assemble shippers, removes trash, product waste from packaging area.
• Cleans and sanitizes work areas using broom, wipes, mop, or cleaning machine, (i.e. gowning area, packaging floor perimeter and fill rooms).
• Weighs or counts product for disposal, documents weight and disposes accordingly.
• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency.
• Maintain effective communication between shifts.
• Perform Packaging Pharma Operator duties as necessary.
• Maintains supply of PPE (i.e. gloves, sleeves, dust masks) isopropyl alcohol (IPA) and wipes on packaging lines.
• Work with equipment such as ladders, manual floor jack, dollies, and be able to service multiple packaging lines simultaneously.
• Alerts Supervision, Mechanics and Quality personnel of safety, quality and equipment performance problems when they occur.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee must be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.

In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.

All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.

Key Performance Indicators
• Solid English reading/comprehension written and verbal communication skills required to understand and communicate to others detailed cGMPs, SOP's, FI’s, and production equipment cleaning instructions.
• Basic mathematical skills and ability to work with numbers to accurately count components, waste and finished goods products.
• Support and implement safety initiatives, wearing all personal protective equipment (PPE), and displaying safe work performance according to company standards.
• Perform key roles in a manner that motivates personnel, promotes teamwork, is respectful of others while remaining aligned with company’s behaviour expectations.
• Takes initiative and works autonomously to meet production requirements.
• Continues to develop and learn new skills, which will allow for further advancement within the organization.

Job Dimensions
Number of associates:
0
Impact on the organization: Medium

Ideal Background
Education: • High School Diploma or GED. Associates Degree preferred. Equivalent experience can be considered in lieu of HS Diploma
• Minimum of one year production experience
Experience: • Ability to lift 50 lbs. and maintain a high level of physical activity]]> Mon, 23 Mar 2026 00:00:00 EDT 1

We are seeking a Specialist Physician to support the care of patients with kidney disease across all stages of their condition. You will oversee diagnostics, treatment decisions and long?term management, ensuring patients receive safe, modern and compassionate care.
Key Responsibilities

• Manage patients with chronic kidney disease through to advanced renal failure
• Create and monitor individual treatment plans, including dialysis qualification and therapy selection
• Collaborate closely with nurses, dieticians, psychologists and technical staff
• Educate patients on lifestyle changes and self?management
• Plan and interpret diagnostic tests and identify risk factors
• Conduct therapeutic procedures related to renal replacement therapy
• Prepare patients for dialysis or kidney transplantation
• Provide supervisory support in the director’s absence
• Participate in clinical or research activities within the unit

Requirements

• Board certification in Internal Medicine or Nephrology
• Valid licence to practise
• Strong communication skills and empathy
• Willingness to work shifts (arranged individually)

]]> Mon, 23 Mar 2026 00:00:00 EDT 1

We are seeking a Specialist Physician to join a centre focused on delivering high quality medical care to patients with kidney disease. In this role you will provide support to individuals across all stages of renal conditions from early chronic kidney disease through advanced renal failure. You will be responsible for accurate diagnostics personalised treatment planning and consistent long term follow up that helps patients maintain the best possible quality of life.

You will collaborate closely with a multidisciplinary team including nursing dietetics psychological and technical staff. Your work will help patients understand their condition make informed treatment choices and manage their health with confidence.
What You Will Do

• You provide comprehensive medical care for patients with kidney disease
• You develop and supervise personalised treatment plans including qualification for dialysis and choice of therapy
• You work in close partnership with nursing dietetic psychological and technical teams to ensure coordinated care
• You educate patients on lifestyle adjustments and long term self management
• You plan diagnostic steps provide explanations of available options and interpret clinical results
• You perform therapeutic procedures related to renal replacement therapy
• You prepare patients for dialysis and for kidney transplantation in line with current standards
• You support the medical team when leadership presence is required
• You contribute to clinical and research activities carried out in the unit

What You Bring

• You have board certification in Internal Medicine and or Nephrology
• You hold a valid licence to practise medicine
• You demonstrate strong interpersonal skills empathy and a patient centred mindset
• You are open to shift based work with schedules arranged individually

]]> Mon, 23 Mar 2026 00:00:00 EDT 1

Szukamy lekarza specjalisty, ktory chce rozwijac swoja praktyke w nowoczesnym osrodku zajmujacym sie kompleksowa opieka nad pacjentami z chorobami nerek. To rola, w ktorej liczy sie nie tylko doswiadczenie kliniczne, ale rowniez podejscie do pacjenta i gotowosc do dlugofalowej wspolpracy z zespolami medycznymi.

W tej pracy spotkasz sie z pelnym przekrojem schorzen nerek – od wczesnych etapow przewleklej choroby nerek, az po niewydolnosc wymagajaca terapii zastepczej. Twoim zadaniem bedzie prowadzenie diagnostyki, tworzenie indywidualnych planow leczenia oraz przygotowanie pacjentow do dializ lub transplantacji. Bedziesz blisko wspolpracowac z pielegniarkami, dietetykami, psychologami oraz personelem technicznym, aby zapewnic pacjentom stabilna, bezpieczna i profesjonalna opieke na kazdym etapie leczenia.

Rola obejmuje rowniez udzial w projektach klinicznych, edukacje pacjentow, monitorowanie przebiegu choroby oraz wsparcie zespolu w zakresie organizacji pracy medycznej. Szukamy osoby, ktora potrafi laczyc wiedze specjalistyczna z empatia i jasna komunikacja.

Wymagamy ukonczonej specjalizacji z chorob wewnetrznych lub nephrologii oraz waznego prawa do wykonywania zawodu. Praca obejmuje dyzury, ustalane indywidualnie. Cenimy otwartosc, wspolprace i zaangazowanie w codzienna praktyke kliniczna.

Jesli chcesz pracowac w miejscu, w ktorym liczy sie jakosc leczenia i realny wplyw na zycie pacjentow, ta rola bedzie dla Ciebie doskonala.
]]> Mon, 23 Mar 2026 00:00:00 EDT 1

We are looking for a Specialist Physician to provide comprehensive care to patients across the full continuum of kidney disease. In this role, you will support patients from the early stages of chronic kidney disease through end?stage renal failure, ensuring high?quality diagnostics, individualised treatment planning, and long?term management.

Working as part of a multidisciplinary clinical team, you will implement modern therapeutic approaches, educate patients on self?care and lifestyle adjustments, and help them maintain the best possible quality of life.
Key Responsibilities

• Provide holistic medical care for patients with kidney disease, from early CKD stages to dialysis dependency
• Develop and oversee individual treatment plans, including dialysis qualification, choice of treatment modality, and optimisation of pharmacotherapy in line with current nephrology guidelines
• Collaborate closely with nurses, dieticians, psychologists, and technical staff
• Educate patients on disease management, self?care, and lifestyle modifications
• Identify health risk factors and preventative needs in dialysis patients
• Plan diagnostic activities, inform patients about available options, order and interpret additional tests
• Perform therapeutic interventions in the field of renal replacement therapy
• Prepare patients for their selected form of renal replacement therapy, including counselling on indications, contraindications, and risks
• Prepare patients for kidney transplantation in accordance with established procedures
• Lead the medical team in the absence of the station director
• Participate in research programmes within the organisational unit

Your Profile

• Board certification in Internal Medicine and/or Nephrology
• Valid licence to practise medicine
• High level of empathy and strong interpersonal skills
• Willingness to work shifts (details to be agreed)

]]> Mon, 23 Mar 2026 00:00:00 EDT 1

We are looking for a Specialist Physician to strengthen a centre focused on delivering modern, patient?centred care for individuals with kidney disease. In this role, you will oversee patients across all stages of renal dysfunction — from early chronic kidney disease through advanced renal failure — ensuring safe diagnostics, personalised treatment decisions and consistent long?term follow?up.

You will collaborate closely with a multidisciplinary team and play a key role in supporting patients in understanding their condition, managing their therapy and maintaining a stable, active daily life.
Your Responsibilities

• Provide full-spectrum medical care to patients with kidney disease
• Develop and supervise tailored treatment strategies, including dialysis qualification, appropriate therapy selection and medication optimisation
• Work hand?in?hand with nurses, dieticians, psychologists and technical staff to ensure coordinated care
• Educate patients about lifestyle adjustments, self-care practices and long?term disease management
• Identify health risks and deliver preventative measures for dialysis patients
• Plan diagnostic workflows, communicate available options and interpret relevant tests
• Perform therapeutic interventions related to renal replacement therapy
• Prepare patients for their chosen dialysis method, explaining indications, contraindications and potential risks
• Support patients in preparing for kidney transplantation following established procedures
• Take on supervisory responsibilities for the medical team when the station director is absent
• Participate in clinical and research initiatives within the unit

Your Profile

• Board-certified in Internal Medicine and/or Nephrology
• Valid licence to practise medicine
• Strong interpersonal skills, empathy and a patient?focused approach
• Willingness to work shifts (schedule arranged individually)

]]> Mon, 23 Mar 2026 00:00:00 EDT 1

We are seeking a Specialist Physician to join a centre dedicated to delivering high?quality care for patients living with kidney disease. In this role, you will guide individuals through every stage of their renal journey — from early chronic kidney disease to advanced renal failure — ensuring they receive coordinated, evidence?based medical support.

You will work side?by?side with a multidisciplinary team and play a key part in helping patients understand their condition, manage their treatment, and maintain the highest possible quality of life.
What You’ll Do

• Provide comprehensive medical care to patients across all stages of kidney disease
• Design, adapt and oversee personalised treatment plans, including dialysis qualification, therapy selection and pharmacotherapy optimisation
• Coordinate with nurses, dieticians, psychologists and technical personnel to deliver integrated care
• Educate patients on lifestyle strategies, self?management and long?term disease control
• Identify risk factors and implement preventative measures for dialysis patients
• Plan diagnostic pathways, explain available options, and interpret complementary tests
• Carry out therapeutic procedures related to renal replacement therapy
• Prepare patients for their chosen form of renal replacement therapy and counsel them on indications, contraindications and potential risks
• Support patients preparing for kidney transplantation in line with current standards
• Step in to supervise medical staff in the absence of the centre’s director
• Contribute to ongoing clinical and research initiatives within the unit

What You Bring

• Board certification in Internal Medicine and/or Nephrology
• Valid licence to practise medicine
• Strong empathy, excellent communication skills and a collaborative approach
• Flexibility and readiness to work shifts (details to be arranged)

]]> Mon, 23 Mar 2026 00:00:00 EDT 1 Job Description:

This microbiologist role will have a strong background in performing method development, method validation, method transfer activities as well as routine testing of raw materials, in-process testing and finished product. This exciting role will support microbiological activities for the organization, which includes R&D as well as commercial manufacturing. The candidate must have experience in cGMPs, regulatory body requirements and FDA compliance. The candidate must be proficient in microbiological testing per USP/EP/JP. The ideal candidate would be versatile, flexible, extremely organized, ability to adapt to project demands and ability to prioritize work to meet timelines. The candidate must have an understanding of aseptic processes and manufacturing.

Responsibilities:
Develop and implement microbiological strategies and procedures to ensure compliance with industry standards and regulations
Perform method development, feasibility and validation of raw materials, in-process and final product
Conduct routine microbiological testing and analysis of samples, ensuring accuracy and reliability of results.
Perform routine and stability testing of GLP and GMP supplies
Write and revise SOP’s, validation protocols/reports
Perform testing as needed to generate data for validation and special projects. Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ)
Maintain accurate and up-to-date documentation of all microbiological activities, including test results, procedures, and reports
Review and interpret test results, prepare reports, and communicate findings to relevant stakeholders Identify and implement improvements to existing microbiological processes, methods, and techniques to enhance efficiency and productivity
Collaborate with cross-functional teams, such as quality assurance, research and development, and production, to support product development and continuous improvement initiatives
Stay updated with the latest advancements and trends in the field of microbiology and recommend and implement new technologies and methodologies as appropriate
Ensure compliance with relevant regulatory requirements and standards, such as Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), and ISO standards

Requirements
Required Skills:
Proficiency in microbiological techniques such as aseptic testing, microbial monitoring, gram staining, and plating
Proficiency in testing according to AAMI/ISO/USP Standards
Knowledge and control of laboratory equipment including calibration and maintenance
Ability to understand and perform all required tasks by adhering to company Standard Operating Procedures and all current Good Manufacturing Practices Understanding of quality systems including change control, deviations and CAPAs; support investigations as needed
Ability to handle multiple tasks concurrently and complete tasks in a timely manner
Strong written and verbal language skills to effectively read and write SOP’s and related lab reports and effective communication skills to present data with personnel at all levels in the organization
Excellent teamwork skills, organizational skills, and strong attention to detail Knowledgeable in regulatory requirements and industry standards related to microbiology
Proficient in using microbiological testing equipment and software; Knowledge and proficiency in computer software (e.g. Microsoft Office programs)
Attention to detail and high level of accuracy in performing microbiological tests and analysis and excellent analytical and problem-solving abilities to interpret test results, troubleshoot issues, and recommend solutions
Ability to work collaboratively in cross-functional teams and adapt to changing priorities and deadlines
Strong organizational and time management skills to prioritize tasks and meet project timelines

Minimum Required Qualifications:
Bachelor's degree in Microbiology, Biology or related scientific field Minimum 8 years of related pharmaceutical experience in a cGMP environment

Pay $45-57 based on experience 
]]> Mon, 23 Mar 2026 00:00:00 EDT 1 Exciting Opportunity for a Biopharmaceutical Scientist in Barcelona!

Type: Permanent
Location: 100% onsite in Barcelona

Join a dynamic team supporting cutting-edge projects in a GMP/GLP environment, where your expertise will help drive innovations in biopharmaceutical research and development. This role offers a fantastic chance to grow your career while working on impactful biologics and small molecules.

We’re seeking a proactive scientist with a solid foundation in analytical techniques like HPLC and biologics, ready to support method transfer, validation, and compliance activities. Whether you have experience in GMP or GLP processes, your background in industry or research makes you a great fit!

Key skills include experience in pharma or biotech settings, hands-on knowledge of both small and large molecule analysis, and strong communication skills in English and Spanish. The ideal candidate holds a Bachelor's degree in Chemistry, Biochemistry, Biotechnology, or related field, with 1-2 years of relevant experience. Prior exposure to GMP or GLP environments is highly valued.

Additional helpful skills include familiarity with biologics techniques or experience with investigational research. Candidates should be open to relocating, though active support for relocation is not currently provided.
If you're passionate about advancing biopharmaceutical sciences and looking for a clear career progression from analyst to scientist, don’t miss this chance—apply now and take your next step in Barcelona’s vibrant biotech scene!
 
]]> Sun, 22 Mar 2026 00:00:00 EDT 1
Essential Duties and Job Functions:
• Support the lead training manager by managing assigned components of training initiatives (i.e. planning, execution and follow up) to ensure timelines, quality and objectives are met.
• Lead and collaborate on the development and implementation of knowledge/skill-based training focused on ensuring success through therapeutic disease state and product knowledge for commercial field sales
• Develops and executes training with a specific focus on our new hire program Accelerate as well as account management skills, product knowledge, new promotional campaigns, product launches, communication skills, selling skills, phased trainings, sales meeting training workshops, ongoing learning sustainment programs & other as needed field sales.
• Collaborates with and supports relevant internal departments, including Marketing, Commercial (Field Sales, National Accounts, Regional Trainers), Commercial Operations, Global L&D, Medical Information, Legal, Business Conduct and Regulatory to develop appropriate training.
• Collaborates with internal customers including Compliance/Legal, Marketing and Medical Information to ensure training materials and workshops are current, effective and compliant with regulatory guidelines.
• Partners with external vendors to design curricula or programs and planning of instructional methods and materials using adult learning principles.
• Effectively prepares for instruction by conducting needs assessments, identifying targeted participant characteristics, and soliciting cross-functional feedback before finalizing design and strategy.
• Offers solutions for bridging gaps between current organizational capabilities and needs.
• Helps ensure readiness of the organization for training deployment including identifying key stakeholders and determining their needs in advance, in order to deliver high quality and effective programming.
• Analyzes the characteristics of existing technologies and their use in instructional design.
• Partners with subject matter experts and key stakeholders to identify training needs, improve training solutions and lead change initiative implementation.
• Monitors and maintains alignment with Commercial groups strategic training plan while balancing short-term and long-term business goals.
• Manages budget aligned with both the development of training resources and / or POA / Sales Meetings

Knowledge, Experience and Skills:
• Proficiency in Microsoft Office applications including Word, Teams and PowerPoint, particularly as used in the development of instructional content.
• Highly self-motivated and self-managed; ability to work independently and as part of a team with minimal coaching or supervision.
• Ability to organize and work under strict time and production deadlines, while producing quality deliverables.
• Good organization skills, time management, and the ability to juggle multiple tasks are all prerequisites of an effective project manager.
• Excellent facilitation and communication skills.
• Demonstrated ability to simultaneously handle a large and diverse number of technical tasks and issues with tact, cooperation and persistence.
• Demonstrated ability to build consensus and gain alignment with key stakeholders
• Demonstrated ability to lead without authority
• Strong organizational and problem-solving skills.
• Comfortable working with people at all levels of the organization globally as well as with suppliers, vendors and customers.
• Ability to effectively communicate in visual, oral and written presentation forms.
• Ability to effectively manage a project from its initiation to delivery, either as live training or as a virtual deliverable.
• Ability to effectively manage multiple vendors from selection to final deliverable
• Must have the ability to focus on performance by establishing clear objectives for the training.
• Strong interpersonal communication, facilitation, problem solving, decision making and analytical skills.

Minimum Experience:
• High School Degree and Twelve Year's Experience
OR
• Associates Degree and Ten Years Experience
OR
• Bachelor's Degree and Eight Years Experience
OR
• Masters' Degree and Six Years Experience
OR
• Ph.D.

Preferred Experience:
• MS degree plus 6 years in related field is desirable
• 5+ years of commercial pharmaceutical/biotech experience
• 3 years of successful Field Sales experience
• 1 year Prior commercial training experience
• Experience in HIV is preferred, launch experience preferred
• Sales, marketing, or training experience in a competitive biotech/pharma marketplace

Pay ranges between 70-73/hr ]]> Fri, 20 Mar 2026 00:00:00 EDT 1 Description:

Summary:
Perform a variety of clinical procedures to collect, record, report and interpret data on patients enrolled and/or seeking enrollment in clinical studies according to the protocol, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Assist with daily workload planning.

RESPONSIBILITIES

• Provide clinical research support to investigators to prepare for and execute assigned research studies, including:
• Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data.
• Attend all relevant study meetings.
• Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
• Recruit and screen patients for clinical trials and maintain subject screening logs.
• Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits.
• Design and maintain source documentation based on protocol requirements.
• Schedule and execute study visits and perform study procedures.
• Collect, record and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy and completeness.
• Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics.
• Monitor subject safety and report adverse reactions to appropriate medical personnel.
• Correspond with research subjects and troubleshoot study-related questions or issues.
• Participate in huddles to confirm daily study tasks are assigned to team members and are executed to the expected standards.
• Assist with study data quality checking and query resolution.
• Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation and cardiac telemetry monitoring.
• Record, report and interpret study findings appropriately to develop a study-specific database.
• Assist investigator in verifying that research study objectives are met on time, within budget and according to applicable protocol requirements, clinical research regulations and quality standards.
• Provide training to new investigator site staff members on study-specific topics and requirements.
• Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records.
• Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies.
• Assist research site with coverage planning related to staffing and scheduling for research projects.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Knowledge of clinical trials.
• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules.
• Knowledge of medical terminology.
• Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word.
• Excellent interpersonal skills.
• Ability to pay close attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• High school diploma (a BS would be a plus) or educational equivalent and relevant work experience in a clinical environment or medical setting, or equivalent combination of education, training and experience.
• Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies.

Pay Rate Range: $30-38/hr depending on experience 
]]> Fri, 20 Mar 2026 00:00:00 EDT 1
The ideal candidate will possess a strong background in contract administration within the life sciences, biotechnology, or pharmaceutical sectors, with a specific focus on research and service-related agreements. As a Contracts Administrator, you will be a central point of contact, collaborating closely with our Legal, Procurement, Finance, and scientific teams to facilitate the timely execution and tracking of contracts. This position requires a proactive individual with excellent analytical, project management, and systems management skills, who can expertly navigate multiple databases and procurement systems.

Reporting to the Vice President of ReDev Operations, you will be responsible for processing a variety of contracts, including confidentiality agreements, vendor service agreements, work orders, and consulting agreements, as well as managing purchase requisitions and other procurement-related activities.

Key Responsibilities
•Contract Management: Partner with legal and procurement teams to manage a high volume of contracts on behalf of our scientists, including service agreements, consulting agreements with healthcare providers, sponsored research agreements, and non-disclosure agreements (NDAs).
•Liaison & Coordination: Serve as a key liaison between internal business partners, the legal department, and external vendors to ensure seamless contract coordination and communication.
•Negotiation & Review: Collaborate with the legal team to manage redline changes and reviews, advancing contracts efficiently through the signature process.
•Lifecycle Management: Work in close collaboration with cross-functional teams and external vendors on contract maintenance, renewals, and terminations.
•System Integrity: Ensure all fully executed contracts are accurately entered and maintained in our contract management system (IronClad).
•Compliance & Reporting: Work closely with Finance and other departments to ensure adherence to cross-functional policies, procedures, and reporting standards.
•Procurement: Review purchase requisitions and accurately convert them to purchase orders within our SAP Ariba system.

Qualifications
•A minimum of 1-3 years of experience in a legal or professional office environment within the life sciences industry is strongly preferred.
•Exceptional verbal and written communication skills, with a proven ability to interact effectively with individuals across all levels of the organization.
•Familiarity with key healthcare compliance laws is preferred.
•Demonstrated ability to multitask, problem-solve, and thrive in a fast-paced environment.
•Proven ability to handle confidential and proprietary information with the utmost discretion and judgment.
•Strong experience with contract management systems (e.g., IronClad), electronic signature platforms, and other legal software.
•Proficiency in the Microsoft Office Suite (Outlook, Excel, Word, PowerPoint, Teams).

Pay ranges between 40-46/hr based on experience ]]> Fri, 20 Mar 2026 00:00:00 EDT 1 Play a critical role in the development of new life science technology as a reliability engineer in the R&D group.  Provide hands-on, analytical, and reliability expertise to support engineering programs associated with the development of complex instruments.  Work in a team environment to assess and improve product reliability throughout the design process.  Manage reliability projects by implementing tests, analyzing data, assessing reliability risks, and reporting accurate information to stakeholders.

 

Primary duties include the following:

• Lead and monitor multiple reliability projects.
• Provide reliability risk assessments to cross-functional teams and executive leadership.
• Create and implement test plans to effectively mitigate risks in new product designs.
• Facilitate and direct multidisciplinary discussions to evaluate technical risk through FMEA.
• Leverage internal and external resources to complete reliability test plans.
• Record, organize, and manage large amounts of detailed test data.
• Methodically analyze test data and interpret results for critical reliability decision-making.
• Troubleshoot instrument failures and/or reliability issues as necessary.
• Direct, execute, and document root cause investigations.
• Guide the team to corrective action identification, implementation, and validation.
• Escalate top issues by providing clear, well-structured, high-level updates.
• Provide engineering input for new designs to ensure reliable and robust products.

 

Minimum Qualifications:

Education and Experience:

• Minimum of a Bachelor's degree in engineering or related discipline required.
• Minimum of 5 years of reliability engineering experience or experience performing tests to collect experimental data and performing statistical analyses to interpret results. (2 years may be substituted with advanced degree in engineering or related discipline)
• Knowledge of reliability fundamentals and understanding of reliability analysis (i.e., life predictions, product life modeling, root cause analysis, environmental testing, accelerated testing, etc.)
• Applies technical standards, principles, concepts, and techniques to solve problems.
• Excellent communication skills.
• Willingness to work in BSL2 lab
• Willingness to prepare blood samples for testing (training will be provided).

 

In addition to the above minimum qualifications, the following are considered highly desirable:

• Knowledge of fluidic, optical, and/or electro-mechanical systems.
• Experience with test automation (LabView, Arduino, etc.).
• Experience utilizing FMEA to guide team discussions and priorities.
• Statistical knowledge, especially related to six sigma tools and methodology, design of experiments, and reliability modelling.
• Experience managing large sets of data using data processing tools such as Minitab, MATLAB, JMP, or R.

Fully onsite
Pay $40-50/hr based on experience]]> Fri, 20 Mar 2026 00:00:00 EDT 1 Can you please confirm your top 3 skills sets required? 

• Circuit Debugging experience
  PCBA Design and test experience
  Proven Hands on Electronic Mechanical Skills 

Can you please confirm the 3 main responsibilities/day to day activities required for this role? 

• Board test plan and initial execution
  Track, determine root cause, recommend solutions to issues identified by hardware and cross functional teams 
  Manage prototype hardware in the lab/local locations 

What is your target years of experience? 5-10 Years 

When do you plan to start interviewing?? ASAP 

Will you be looking to hire and start ASAP or will the start date be delayed?  April 6th is the earliest Start date 

Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?? Onsite 4 days a week? 
_____________________________________________________________________________________________________

Job Responsibilities may include  

• 
  Manage prototype hardware in the lab/local locations 
  
• 
  State of PCBAs 
  
• 
  Apply/ensure rework is consistent across all systems (include directing technicians to perform this work) 
  
• 
  Manage software/PL installed on the systems/PCBAs 
  
• 
  Support software, systems possibly DA with PCBA 
  
• 
  Issue debug 
  
• 
  Board test plan and initial executifon 
  
• 
  Receive initial Boards 1 PCBAs 
  
• 
  Develop low level checkout 
  
• 
  Ohmic checks 
  
• 
  Initial power on 
  
• 
  Low level register testing (per PCBA if applicable) 
  
• 
  Lead technicians once initial PCBAs are tested 
  
• 
  Resource as test failures occur 
  
• 
  Debug failures with technician assist. 
  
• 
  Assist with EMC test setup (local internal prescreen and local test house) 
  
• 
  Work hand in hand with PL team to test hardware interface and expected results 
  
• 
  Develop/test board functions, ADC interfaces, DAC interfaces as needed. 
  
• 
  Bridge External Contract House, Systems team, DA team and EE team on catheter simulator design 
  
• 
  Assist with PCBA testing for first units 
  
• 
  Design lab test fixtures, test boards to support functional testing for EE team, systems team 
  
• 
  Participate in design reviews for schematics, layout 
  

 
Position Overview: 

The Sr. EE is an individual contributor within our technical functions, responsible for advancing existing technology and introducing new technologies and therapies. This role involves formulating, delivering, and managing assigned projects, collaborating with various stakeholders to achieve desired outcomes. The Sr. EE may mentor colleagues or oversee the work of lower-level professionals. Most of their time is dedicated to delivering R&D, systems, or initiatives related to new technologies or therapies—from conception through implementation—while adhering to company policies and leveraging specialized knowledge and skills. 

Key Responsibilities: 

• 
  Research, develop, design, and test electrical components, equipment, systems, and networks. 
  

• 
  Design electrical equipment, facilities, components, products, and systems for commercial, industrial, and domestic purposes. 
  

• 
  Formulate, deliver, and manage projects, working with cross-functional teams to achieve project goals. 
  

• 
  Mentor colleagues and provide guidance to entry-level professionals and employees in the Support Career Stream. 
  

• 
  Participate in design reviews for schematics and layout. 
  

• 
  Assist with testing and development of PCBA units and lab test fixtures. 
  

• 
  Bridge communication between external contract houses, systems teams, DA teams, and EE teams on design projects. 
  

Differentiating Factors: 

• 
  Autonomy: Operates independently with general supervision, handling larger and moderately complex projects or assignments. 
  

• 
  Organizational Impact: Sets objectives for their job area to align with project and assignment goals, contributing to project milestones and occasionally participating in cross-functional assignments. 
  

• 
  Innovation and Complexity: Addresses general problems and issues that may require a broad understanding across job areas. Makes adjustments or recommends enhancements to systems and processes to solve problems or improve job area effectiveness. 
  

• 
  Communication and Influence: Communicates primarily with internal contacts to share information, status, needs, and issues, supporting decision-making processes. External interactions are typically straightforward and focused on problem-solving. 
  

• 
  Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and employees in the Support Career Stream. 
  

• 
  Required Knowledge and Experience: Requires practical knowledge and demonstrated competence in the job area, typically obtained through advanced education combined with relevant experience. 
  

]]> Fri, 20 Mar 2026 00:00:00 EDT 1 Thu, 19 Mar 2026 00:00:00 EDT 1 A growing med?tech company with a strong Australian presence is expanding into Orthopaedics and is looking for a Territory Manager to lead Hip & Knee reconstruction activity across Sydney. You’ll launch a new product line while working alongside an existing local team in another therapy area.

---

Key Responsibilities

• Drive sales for Hip & Knee reconstruction across Sydney
• Build relationships with surgeons, hospitals and OR teams
• Provide case support, education and product guidance
• Manage territory operations, pricing alignment and account planning
• Support distributor/agent relationships where needed
• Track market insights, competitive activity and procedural trends
• Ensure compliance with local regulations and internal standards

---

Requirements

• 3+ years’ experience selling Hip & Knee implants
• Recent orthopaedic theatre exposure
• Strong commercial and relationship?building skills
• Comfortable operating independently in a growth environment
• Experience with distributor/channel management is a plus

]]> Thu, 19 Mar 2026 00:00:00 EDT 1 The Opportunity:   Senior Clinical Program Manager, Clinical Operations Compliance & Training

This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.

• 
  Support Clinical Operations with GCP guidance and best industry practices.
  
• 
  Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.
  
• 
  Contribute to the management of business and compliance metrics to assess and continuously improve oversight and inspection readiness throughout the clinical trial lifecycle.
  
• 
  Support Clinical Operations Inspection Readiness activities.
  
• 
  Contribute to Clinical Operations training programs to deliver standards, GCP, and regulatory requirements.
  
• 
  Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responses.
  
• 
  Communicate deliverable status/issues, and problem solve to ensure functional goals are met.
  
• 
  Use all available tools to track, oversee, and communicate on project status to all key stakeholders.
  
• 
  Participate in other Clinical Operations Compliance & Training activities as assigned.
  

Required Skills, Experience and Education:

• 
  RN or Bachelor’s or Masters degree in biological sciences or health-related field required.
  
• 
  10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industryor  Clinical Research-related experience.
  
• 
  Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, current industry practices.
  
• 
  Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.
  
• 
  Experience with development and monitoring of oversight activities.
  
• 
  Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  
• 
  Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.
  
• 
  Excellent written/verbal communication and interpersonal skills.
  
• 
  High sense of priority and commitment to excellence in the successful execution of deliverables.
  
• 
  Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
  
• 
  Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  
• 
  Travel may be required (~25%).
  

Preferred Skills:

• 
  Oncology experience, early and/or late stage.
  
• 
  Knowledge and/or familiarity with Ex-US region(s) regulations and requirements.
  

]]> Thu, 19 Mar 2026 00:00:00 EDT 0 Job Description:
The IT Desktop Support Technician III provides hands-on technical support, manages IT assets, and owns onboarding/offboarding for both onsite and remote employees.
This role requires a customer-focused mindset, strong troubleshooting skills, and the ability to work independently in a fast-paced environment.
This position plays a critical role in ensuring system stability, security, and scalability while supporting ongoing IT projects and operational improvements.

Responsibilities
Develop training materials and procedures, or train users in the proper use of hardware or software
· Set up equipment for employee use, performing or ensuring proper installation of cables, operating systems, or appropriate software
· Install and perform minor repairs to hardware, software, or peripheral equipment, following design or installation specifications
· Maintain records of daily data communication transactions, problems and remedial actions taken, or installation activities
· Read technical manuals, confer with users, or conduct computer diagnostics to investigate and resolve problems or to provide technical assistance and support
· Refer major hardware or software problems or defective products to vendors or technicians for service
· Assist with onboarding of new employees
· Make recommendations for hardware and software for the organization
· Perform desktop and laptop system deployments including hardware and software configuration
· Provide regular updates on the status of tickets, open issues and projects
· Perform troubleshooting of supported desktop operation systems and applications.

Requirements
· Typically requires a minimum of 2-5 years of related experience
· Advanced experience with Windows, macOS, and enterprise IT environments.
· Experience supporting Active Directory, Entra ID, and Office 365 environments.
· Able to plan and prioritize workload with minimal supervision
· Excellent customer service skills
· High School diploma or equivalent experience is required. Bachelor’s degree preferred

Pay $29-36 based on experience]]> Thu, 19 Mar 2026 00:00:00 EDT 1 Job Description
The Director, Payer Relations is responsible for leading the US Payer Relations team to achieve favorable coverage, coding, and reimbursement. This role oversees reimbursement strategy and execution across commercial payers, Medicare Administrative Contractors (MACs), and Medicaid within an assigned region, with a focus on ensuring appropriate payment, minimizing access barriers, and supporting utilization.
The Director leads and develops the team, ensuring effective coordination of reimbursement support for key opinion leader healthcare providers and institutional customers. The role partners closely with Patient Services to deliver consultative support addressing reimbursement challenges and collaborates cross?functionally with Sales, Market Access, Medical Affairs, Marketing, and Customer Relations to advance payer and provider strategies.
This position serves as a subject matter expert in payer policy and reimbursement, engaging regularly with commercial and government payer stakeholders, including medical directors, policy and provider relations teams, CMS MAC leadership, Medicaid agencies, and state and federal health organizations. The Director also builds relationships with advocacy groups, professional societies, and healthcare systems to establish sustainable access pathways for current and future technologies.
What Will You Do

• Lead and manage the team to develop and execute coverage and reimbursement strategies for national and regional commercial plans, Medicare, and Medicaid.
• Drive payer engagement to secure coverage for newly marketed products, resolve reimbursement challenges, and reduce barriers to patient access.
• Support KOL healthcare providers by addressing reimbursement needs in partnership with Sales and Market Access leadership.
• Establish and maintain strategic payer and stakeholder relationships to support long?term growth.
• Provide regular payer and reimbursement updates to senior leadership.
• Execute outreach with state and local provider, patient, and healthcare advocacy organizations.
• Travel approximately 50%.

How Will You Get Here

• Bachelor’s degree required.
• 12+ years of industry experience, including at least 10 years in medical device, biotechnology, or pharmaceutical sectors.
• Minimum of 4 years of people management experience.
• At least 2 years of demonstrated payer leadership experience.
• Strong communication skills with the ability to articulate clinical value and reimbursement strategy.
• Proven leadership, relationship management, and cross?functional collaboration skills.
• Strong organizational, operational, and budget management capabilities.

Preferred Qualifications

• Experience with patient management programs.
• Familiarity with patient CRM systems.
• Prior call center experience.

  ]]> Thu, 19 Mar 2026 00:00:00 EDT 1

Responsible for performing the activities associated with the preparation of vaccine components in an aseptic clean room environment utilizing virus and cell culture techniques according to USDA regulations

Ensure compliance to the Standard Operating Procedures during execution of processes. Assist with training and coaching of current and new employees on required skills

Complete/Review in process documentation for accuracy and compliance in a timely manner; maintenance of technical data and support documentation 

Participate in root cause analysis and implement corrective and preventative actions to address problems; escalation of production flow disturbances

Demonstrate a visible and tangible commitment to EHS (Environment, Health, and Safety) programs and initiatives

Assessment of individual performance in regards to the continuous improvement (AAI)

Participate and provide support to site projects and initiatives (including deviation and change control management)

Skills:    

Demonstrated strong organizational and time management skills with exceptional attention to detail.  Clean room and aseptic technique knowledge.  Basic understanding of Lean Manufacturing Principles

Basic math skills, equipment/automation trouble shooting skills.  Proficient with Microsoft Office and other database software systems.  Excellent oral and written communication skills. Ability to work in a team environment. Demonstrated ability to problem solve.   Education:    

• High School Diploma or equivalent.  Preferred Biology Degree or related field,one year or more of laboratory experience and/or manufacturing experience.

Pay Rate: $20/hr]]> Thu, 19 Mar 2026 00:00:00 EDT 1 Join Our Team as a Senior Medical Writer – Make a Difference in Cancer Imaging!

Are you a passionate medical writer with a knack for translating complex scientific data into impactful publications? We’re seeking a talented Senior Medical Writer to help shape the future of oncology diagnostics. This is your chance to work on groundbreaking radiopharmaceuticals that have the potential to transform patient care. With a flexible, home-based setup and the opportunity to collaborate with industry leaders, you’ll play a vital role in advancing scientific understanding and clinical practice.

What You Need:

• Ph.D. in Life Sciences or equivalent experience
• 3-5 years in medical communications, pharma, or med device sectors
• Proven publication writing experience, with at least one acknowledgment as the medical writer, especially in prostate cancer or medical imaging
• Comfortable working with complex data and analysis
• Excellent written and verbal communication skills
• Ability to build strong relationships across teams and stakeholders

Nice to Have:

• Experience with PET imaging or neuro-oncology
• Agency background
• Familiarity with publication guidelines like GPP3 and ICMJE
• PowerPoint proficiency for creating compelling visual content

Preferred Education & Experience:

• Ph.D. with relevant industry experience
• Prior roles involving publication planning and data interpretation

Other Requirements:

• Willingness to meet in the office 4 times per week
• Ability to manage multiple projects in a fast-paced environment
• Full-time availability, with flexible hours (9-17:30)

Ready to contribute your expertise to a forward-thinking organization? Apply now to join a team dedicated to advancing cancer diagnostics and making a real-world impact!
]]> Thu, 19 Mar 2026 00:00:00 EDT 1 We are seeking a skilled Temporary Senior Electrical Technician to support testing, troubleshooting, assembly, and validation of electronic systems, boards, and subsystems.
This temporary role involves hands-on work with PCB soldering and assembly, cable assemblies, test fixtures, and mechanical/electrical documentation.
The technician will collaborate closely with electrical, mechanical, and software engineers to support system integration, ensure functionality, and maintain compliance with quality and regulatory standards.

Key Responsibilities:
• Perform hands-on testing, troubleshooting, and debugging of electronic boards, subsystems, and complete systems.
• Assemble, solder, and inspect PCBAs, including through-hole and surface mount components, ensuring proper component placement and solder quality.
• Assemble, inspect, and verify cable assemblies, including signal, power, and interconnect cables.
• Design, set up, and maintain test fixtures for boards and subsystem validation.
• Develop and maintain mechanical and electrical documentation packages for test Fixtures, including drawings, schematics, and test reports.
• Perform basic fabrication tasks to support prototyping and test fixture development.
• Support verification, validation, and regulatory compliance activities (e.g., ISO 13485, FDA 21 CFR Part 11).
• Collaborate with engineers, software, and mechanical teams to support system integration.
• Handle optical components carefully when required (optics handling experience is a plus).
• Mentor junior technicians on soldering, test procedures, troubleshooting, and proper handling of electronic components.
• Maintain and organize test equipment, tools, and lab resources.
• Identify issues and provide recommendations for corrective actions during testing and troubleshooting.

Requirements
Required Qualifications:
· Associate or bachelor’s degree in Electronics, Electrical Engineering Technology, or related field.
· 5+ years of hands-on experience testing, troubleshooting, and validating electronic systems and boards.
· Strong PCB soldering and assembly skills (through-hole and surface mount).
· Experience assembling and testing cable assemblies and interconnects.
· Experience using test equipment (power supplies, signal generators and o-scopes)
· Experience designing, setting up, and using test fixtures for PCBAs and subsystems.
· Proficiency with MS Office; familiarity with SolidWorks, OrCAD, Arena PLM, or Altium is a plus.
· Strong documentation skills for test reports, cable layouts, and subsystem validation.
· Basic fabrication skills (cutting, drilling, assembly) for prototyping and fixture support.
· Good understanding of analog, digital, and mixed-signal electronics.
· Excellent written and verbal communication skills.
· Self-starter with the ability to work independently with minimal direction.
· Well-organized, detail-oriented, and able to prioritize tasks effectively.

Pay $30-33/hr ]]> Wed, 18 Mar 2026 00:00:00 EDT 1
Duties
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).

TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.

QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).

BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.

WORK ENVIRONMENT/PHYSICAL DEMANDS
• Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.
• Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.
• May require work around loud equipment. • The use of personal protective equipment will be required.
• Requires various shift based work and off hours.

Skills
• Strong communication skills—verbal and written
• Ability to work in a team environment which includes good conflict resolution and collaboration
• Displays good initiative to identify areas for improvement and implement solutions

Education
-Bachelor’s degree in science related area or engineering
-Associate’s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry ]]> Wed, 18 Mar 2026 00:00:00 EDT 1 Job Title: Regulatory Submissions (Study Start-Up) Manager / Associate Director
Location: Seoul, South Korea
Function: Regulatory Submissions / Study Start-Up

Role Overview
A global clinical research organisation is seeking a Regulatory Submissions professional in South Korea, with flexibility to appoint at either Manager or Associate Director level depending on experience and seniority.

This role sits within the Study Start-Up / Regulatory Submissions function and is responsible for leading regulatory submission activities across South Korea, with regional exposure across the APAC region. The position is primarily project-management focused, with limited immediate line management responsibilities and potential for future leadership growth.

Role Level Flexibility
This is one headcount with flexibility on seniority. The organisation is open to:

• 
  Regulatory Submissions Manager profiles with strong hands-on submission and start-up experience, or
  
• 
  Associate Director profiles with broader regional exposure and regulatory leadership experience
  

Final title, scope, and compensation will be determined based on experience and overall fit.

Key Responsibilities (Both Levels)

• 
  Lead and manage regulatory submissions for clinical trials, with a strong focus on study start-up activities
  
• 
  Act as the primary regulatory liaison with the local health authority in South Korea
  
• 
  Coordinate submissions locally and support regional (APAC) regulatory activities
  
• 
  Partner closely with internal stakeholders and external sponsors to ensure timely, compliant submissions
  
• 
  Provide regulatory guidance across multiple projects and contribute to process optimisation and best practices
  
• 
  Support inspection readiness and regulatory strategy initiatives as required
  

Mandatory Requirements – Manager Level

• 
  Bachelor’s degree in a science-related discipline
  
• 
  Minimum 5 years’ experience within a CRO or similar environment
  
• 
  Hands-on experience managing regulatory submissions in South Korea, with some exposure to APAC regions
  
• 
  Strong English communication skills (written and verbal) for interaction with global stakeholders and health authorities
  
• 
  Seoul-based and open to the organisation’s working arrangement:
  
  • 
    Initial period fully office-based
    
  • 
    Transition to a hybrid model thereafter
    
• 
  Line management experience is an advantage, though the role is primarily project-focused
  

Mandatory Requirements – Associate Director Level

• 
  Bachelor’s degree in a science-related discipline
  
• 
  Minimum 8 years’ experience within a CRO or equivalent regulated environment
  
• 
  Strong regulatory submissions experience across South Korea with broader APAC exposure
  
• 
  Excellent English communication skills (written and verbal)
  
• 
  Seoul-based and open to the organisation’s working arrangement:
  
  • 
    Initial period fully office-based
    
  • 
    Transition to a hybrid model thereafter
    
• 
  Prior people-leadership experience is desirable; the role remains project-led initially with scope to expand
  

Compensation & Benefits

• 
  Competitive annual base salary aligned to seniority and experience
  
• 
  Daily commuting allowance for in-office attendance
  
• 
  Annual meal or lunch allowance
  
• 
  Full benefits package aligned with local market standards
  

Additional Information

• 
  This is a single position with flexible seniority, not multiple openings
  
• 
  The role offers strong regional exposure across APAC and long-term growth potential within regulatory leadership
  

]]> Wed, 18 Mar 2026 00:00:00 EDT 1 Position Summary

The Benefits Specialist will lead and manage the design, implementation, and operations of our global benefits programs. Reporting to the Head of People Technology & Operations, this role will be responsible for benefit strategy, budgeting, compliance, and governance across the United States, United Kingdom, Germany, and France. This position plays a critical role in ensuring our benefits offerings are competitive, compliant, and aligned with our organizational values and strategy.

Key Responsibilities

Global Benefits Strategy & Design

· Lead the development and implementation of comprehensive, competitive, and cost-effective benefits strategies across the US, UK, Germany, and France.

· Align local country benefits programs with global corporate philosophy and regional regulatory requirements.

Benefits Operations & Administration

· Oversee day-to-day global benefits operations, including vendor management, plan administration, and annual renewals.

· Serve as the escalation point for complex benefits issues and ensure timely and accurate resolution.

Governance & Compliance

· Prepare and present benefits strategy, program changes, and renewals for Benefit Committee approval.

· Ensure compliance with all local regulations, laws, and reporting requirements in each country of operation.

Budgeting & Forecasting

· Develop and manage the global benefits budget and support regular forecasting activities.

· Analyze trends and utilization to optimize plan design and cost efficiency.

Cross-Functional Collaboration

· Partner closely with Finance, Legal, Payroll, and HR Business Partners to ensure integrated delivery of benefits programs.

· Collaborate with Bayer and BlueRock benefits teams to further alignment and integration.

Employee Communication & Education

· Lead the communication of benefits offerings to employees through multiple channels (e.g., open enrollment, onboarding, intranet).

· Optimize infrastructure and support to ensure employees understand and can maximize the value of their benefits.

Qualifications

· Bachelor’s degree in Human Resources, Business Administration, Finance, or a related field Preferred; Master's or relevant certification (e.g., CEBS, GPHR) a plus.

· Minimum 3–5 years of progressive experience in global benefits strategy and operations, preferably within the biotech or life sciences industry.

· Deep knowledge of benefits regulations and practices in the US, UK, Germany, and France.

· Experience preparing and presenting materials to senior leadership and/or governance committees.

· Strong financial acumen and experience managing benefits budgets and vendor contracts.

· Exceptional project management, analytical, and interpersonal skills.

· Comfortable operating in a matrixed organization with a parent company structure.

· High level of discretion and professionalism in handling sensitive employee data and confidential topics.
]]> Wed, 18 Mar 2026 00:00:00 EDT 1 Join Our Team as a Business Development Manager – Drive Innovation in Life Sciences!

Are you passionate about advancing life sciences and generating impactful business opportunities? We’re seeking a dynamic Business Development Manager to spearhead client engagement and expand our reach within the human life sciences sector. This role offers a chance to work at the forefront of Toxicology, contribute to cutting-edge projects, and grow your career within a fast-paced, innovative environment.

In this crucial role, you will leverage your proven sales and business development expertise to build strong client relationships, identify new market opportunities, and achieve significant sales targets. Your expert knowledge in the life sciences industry and your direct customer-facing experience will be instrumental in driving success and making a real difference.

Required Skills:

• Minimum of 2 years’ commercial/business development experience in the life sciences sector
• Proven track record of executing successful sales deals and achieving targets
• Direct customer-facing sales or service experience in the life sciences industry
• PhD in human biology or a closely related life sciences discipline (e.g., biology, biochemistry, biotech, cell biology, molecular biology, neuroscience, cancer, metabolism, genetics)
• Strong communication and relationship-building skills
• Ability to work collaboratively and autonomously in a fast-paced environment

Nice to Have Skills:

• Experience working within toxicology, CRO, or related sectors
• Knowledge of sales targets and experience meeting or exceeding them
• Existing network and established contacts within the industry

Preferred Education and Experience:

• PhD in a human biology-focused life sciences field
• At least 2 years of relevant commercial or sales experience in life sciences
• Demonstrated success in direct customer-facing roles

Other Requirements:

• Willingness to work at least 2 days per week in the Stevenage office 

If you’re ready to make an impact in the life sciences industry and thrive in a collaborative environment, we want to hear from you! Apply now to join a forward-thinking team committed to innovation and excellence.
]]> Wed, 18 Mar 2026 00:00:00 EDT 1 The Facilities Engineer will assist in the day-to-day operation and maintenance of the facilities across multiple sites within the RTP Hub.

Responsibilities

· Work with Facilities & Engineering team to manage and maintain proper building functionality inside and outside of laboratories including but not limited to, emergency and non-emergency power systems, HVAC units, cold storage, RODI water systems, air compressors, vacuum pumps, and other major utilities systems

· Perform daily site walk through and verify functional check on all major systems and utilities that are critical to our daily operations

· Assist with monitoring the building management system (BMS) as needed, investigate the issue(s), and follow procedures for the appropriate solution according to the issue(s)

· Troubleshoot and diagnose equipment or utilities problems, document findings and report back to the Facilities & Engineering team to work through a solution. Execute facilitating the solution if the task has been assigned to you to carry out

· Attend weekly Facilities & Engineering stand-up team meetings and update team on status of individual action items

· Participate in key project planning meetings with capital projects along with the facilities team, raising concerns and pursuing resolutions during project planning meetings, implementation, and delivery of assigned projects

· Support project delivery and monitor progress through assigned project deliverables, providing updates and recommendations to the internal engineering team

· Manage and maintain timely completion of service ticket requests from all internal users

· Coordinate with the internal customer on status updates of complex issues that develop into projects from work orders

· Collaborate across departments such as EH&S, QA, Lab Operations and Capital Projects to achieve group success in a number of stakeholder and vendor facing challenges

· Work to comply with safety initiatives set forth by EH&S to ensure departmental and organizational compliance

· Assist lab operations and department requests for equipment setup within various labs across the organization

 

About you:

· BS/BA required.

· 4-7 years’ experience in Engineering/Facilities role required.

· Background in mechanical or electrical engineering a plus.

· Strong building utilities systems & HVAC experience preferred with working knowledge and experience using BMS systems.

· Prior pharma & experience working in a laboratory

· Possess basic office skills using a PC and working with MS office tools (Word, Excel, and PowerPoint).

· Skills and experience utilizing CMMS systems, CAD, and other Design programs a plus

· Self-motivated, organized, individual capable of working independently as well as a team contributor.

· Strong oral and written communication skills.

· Excellent interpersonal skills with the ability to interact effectively with teams, internally and externally.
]]> Wed, 18 Mar 2026 00:00:00 EDT 1 Reporting to: Senior Environmental Health & Safety Program Manager

Position Summary
The Environmental Health and Safety Engineering Associate is responsible for supporting, developing, implementing, and maintaining a variety of environmental, health, and safety programs and policies to ensure compliance with all applicable local, state, and federal regulations and to promote a culture of safety and environmental stewardship within the organization. This role involves hands-on work, program management, training, and incident response. The individual will work collaboratively with various departments to identify and mitigate EHS risks, drive continuous improvement, and ensure a safe and healthy work environment for all employees.

Key Responsibilities:
Program Development & Implementation:

• Assist in the development, implementation, and maintenance of EHS programs, policies, and procedures (e.g., Hazard Communication, Lockout/Tagout, Emergency
• Response, Waste Management, Ergonomics, PPE, etc.).
• Ensure programs meet or exceed regulatory requirements and industry best practices.
• Support the implementation of EHS management systems.

Compliance & Reporting:

• Monitor and ensure compliance with all applicable environmental, health, and safety regulations (e.g., OSHA, EPA, DOT, CUPA, local fire codes, etc.).
• Prepare and submit required EHS reports to regulatory agencies in a timely and accurate manner.
• Maintain EHS records, permits, and documentation.
• Participate in and support regulatory inspections and audits.
• Generate and contribute safety metrics (head count, hours, incidents, inspections findings, etc.) to report to Safety Committee and site leadership.

Risk Assessment & Hazard Control:

• Conduct regular EHS inspections, audits, and risk assessments to identify potential hazards and non-compliance issues.
• Recommend and implement corrective and preventative actions (CAPAs) to mitigate risks and address findings.
• Perform Job Hazard Analyses (JHAs) and assist in developing safe work practices.

Training & Communication:

• Develop and deliver EHS training programs for new hires and existing employees on various topics.
• Promote EHS awareness and a proactive safety culture throughout the organization.
• Serve as a resource to employees and management on EHS-related matters.
• Facilitate safety committee meetings and initiatives.
• Incident Investigation & Emergency

Response:

• Lead or participate in incident investigations (accidents, injuries, near misses, spills, etc.) to determine root causes and implement corrective actions to prevent recurrence.
• Maintain incident records and track injury/illness rates (e.g., DART, TRIR, etc.).
• Lead, coordinate, and participate in emergency response activities, including drills and actual emergencies.
• Organize training and lead site specific Emergency Response Team (ERT)

Waste Management:

• Oversee hazardous and non-hazardous waste management programs, including proper labeling, storage, transportation, and disposal in compliance with regulations.

Continuous Improvement:

• Analyze EHS data and trends to identify opportunities for improvement.
• Stay current with new EHS regulations, industry trends, and best practices.
• Support and drive continuous improvement initiatives within EHS programs.
• Perform other duties as assigned.

Requirements, Knowledge, Skills and Abilities

Education:

• Professional Safety & Health Officer/Specialist, Occupational Health and Safety, Industrial Hygiene, or a related field certification (an equivalent combination of education and experience may be considered)
• Minimum of 5 years experience in an EHS role, preferably in a biotechnology, medical device, or manufacturing environment.
• IACUC, animal care, and husbandry.
• Demonstrated experience with EHS program development and implementation.
• Experience with regulatory reporting and compliance.
• Strong understanding of federal, state, and local EHS regulations (OSHA, EPA, DOT, etc.).
• Proficiency in conducting risk assessments, incident investigations, and EHS audits.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong organizational and project management skills with the ability to manage multiple priorities.
• Excellent written and verbal communication skills (including grammar and punctuation), including the ability to develop and deliver effective training.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Ability to work independently and as part of a team.
• Strong interpersonal skills with the ability to influence and engage employees at all levels.

Preferred Qualifications:

• Experience with EHS management systems (e.g., ISO 14001, ISO 45001).
• Trained in Continuous Improvement 5S, Lean, Six Sigma fundamentals.
• Experience with specific EHS software or databases.
• First Aid/CPR/AED certification.
• HAZWOPER certification.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• Ability to stand, walk, sit, climb, balance, stoop, kneel, crouch, or crawl.
• Ability to lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Ability to wear personal protective equipment (PPE) as required, including but not limited to safety glasses, lab coat, hard hats, respirators, safety shoes, etc.
• Work may be performed in office, manufacturing floor, research lab, and vivarium environments.
• Potential exposure to bloodborne pathogens, hazardous materials, chemicals, etc.
• May require occasional travel to other company sites or for training.
• For this role: will need someone that has a lot of experience with hazardous and biological waste and chemical management and chemical waste management. Someone knowledgeable of San Diego county HAZMAT and CERS - online portal for County Hazmat - someone is well versed in chemicals, spill response, chemical and biological waste management.

Pay Rate Range: $40-56/hr depending on experience ]]> Wed, 18 Mar 2026 00:00:00 EDT 1
Major Accountabilities:
Event Planning & Vendor Coordination
• Support association and vendor outreach to secure necessary services for events
• Secure, purchase, and communicate event registrations, exhibit booth needs, and attendee needs (such as hotel rooms)

Key Performance Indicators:
- Timeliness and accuracy of attendee, housing, and registration workflows

Work Experience:
- BS/ BA Degree
- Administrative Assistant experience
- Operations Management
- Project Management
- Trade show & event management

The max pay rate is 22/hr for this position ]]> Wed, 18 Mar 2026 00:00:00 EDT 1 Lead and support solid dosage manufacturing operations, ensuring on-time production, process efficiency, and adherence to quality standards. Mentor junior operators, manage projects, and contribute to continuous improvement initiatives within the manufacturing area.
Key Responsibilities

• 
  Operate and oversee pharmaceutical manufacturing processes, including weighing, granulation, blending, tableting, and capsule filling.
  
• 
  Mentor and train junior operators to ensure skill development and adherence to best practices.
  
• 
  Lead creation, revision, and translation of Standard Operating Procedures (SOPs) for assigned processes.
  
• 
  Coordinate tasks, manage projects, and report progress to management, including deviations, business improvements, and non-routine initiatives.
  
• 
  Participate in cross-functional and global projects as required.
  
• 
  Manage resources, time, inventory of consumables/parts, and area-specific expenses.
  

Qualifications

• 
  Technical college or university graduate, or equivalent practical experience in solid dosage manufacturing.
  
• 
  Hands-on experience as a manufacturing equipment operator in solid dosage processes.
  
• 
  Knowledge of pharmaceutical manufacturing control and GMP requirements.
  
• 
  Strong communication skills for mentoring, reporting, and project coordination.
  

About the Company
A global, research-driven life sciences organization focused on developing and manufacturing innovative solutions for human and animal health.
]]> Tue, 17 Mar 2026 00:00:00 EDT 1
In this role, the individual will be responsible for operating a Gas Chromatograph/Mass Spectrometer and LC-MS/MS for confirmatory testing in accordance with the SAMHSA mandatory guidelines and those of other regulatory organizations for all non-negative test results. This job also requires the individual to perform some QC duties. Must possess degree at the Bachelor level. Degree must be in biology, chemistry, or equivalent related field.

This position is Nonexempt. Hours over 40 will be paid at Time and a Half.

The max pay rate is 18/hr for this position ]]> Tue, 17 Mar 2026 00:00:00 EDT 1 Provides operational support for global pharmacovigilance activities for investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data analysis and management obtained from the integrated database utilized by worldwide pharmacovigilance personnel. Responsible for project implementation and execution of system, including responsibilities for providing safety ongoing business support and ongoing improvements. Key interface with the IT system administrators to verify and test system changes, ensuring that the system is compliant and meets business needs.
The personnel who cover the workplace will develop their activities according to the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs) and Working Practices (WPs) and following the Pharmacovigilance legislation

Responsibilities:
Coordinate and participate in the safety data analysis, review, processing and evaluation in order to prepare aggrega 1. Process and review safety data to develop aggregate safety reports
2. Support to respond to requests from regulatory agencies
3. Coordinate and manage creation of queries for data extraction used in different PV documents
4. Develop training documentation and/or work instructions to determine methods and procedures
5. Work as Signal Analyst during signal management activities including extractions of signal detection reports ensuring document filing and archiving Ensure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities. 1. Take part in self-inspection visits, audits, inspections and in CAPAs management
2. Coordination and management of aggregate safety reports submissions; notifies Regulatory Affairs and business partners accordingly
3. Interact with Regulatory Affairs Department as it relates to aggregate safety documents required by Regulatory Authorities
4. Review legislation to ensure compliance with local regulatory Authorities requirements
5. Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards
6. Management of documentation describing PV applications use, which may include, but not limited to: SOPs, WP, User requirements, functional and/or technical specifications, process flow diagrams
7. Lead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new application
8. Gathering, prioritizing, and planning improvements based on user requests, taking into account overall regulations to the business PV data base operating activities 1. Provide support in the updates in the database configuration of submission rules to Regulatory Authorities
2. Provide support in the updates in the database configuration of products and studies
3. Support drug safety applications with business administration tasks. Key project team technical expert to deliver solutions that are cost effective, sustainable, and meet business requirements Scientific and medical literature review 1. Define with the Knowledge Services Department the strategy of scientific searches that are performed
2. Review scientific literature and bibliographic search results and determine the actions necessary to be taken therewith
Experience:
Drug Safety Analyst should ensure their knowledge of pharmacovigilance practices; existing legislation, regulations and guidelines; medical coding and safety-data administration. Drug Safety Analyst should have a university degree in health sciences/ biosciences and additional training in IT or have a university degree in IT with additional training and/or experience in pharmacovigilance. At least 2 years of relevant experience in pharmacovigilance and 2 years of relevant experience in managing data bases, is usually required. Availability for international travelling when necessary is also required.

Needed Skills: - Proven Self-starter with strong work ethic and the ability to exercise good judgment.
- Ability to work independently with minimum supervision.
- Must be proactive, results oriented, and have strong attention to detail.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
- Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
- Must possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
- Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines
-Proficient in Windows 7 and MS Office (Excel, PowerPoint, Visio, Word)
- Familiarity with validation of computer systems and/or GMP environments is essential.
- Knowledge of E2b (R2) and E2b (R3) is beneficial. Familiarity with Medical terminology, MedDRA,WhoDrug is beneficial
- Familiarity with reporting tools such as Business Objects is strongly preferred.





  Pay Rate Range: $30-45/hr depending on experience  ]]> Tue, 17 Mar 2026 00:00:00 EDT 1 *Depending on experience

Responsibilities
· Provides complex medical information for the assigned therapeutic area(s). This includes developing, maintaining and using product/disease state subject matter expertise to respond to medical information inquiries escalated from affiliate and medical information call center staff, and managing the development, approval, and maintenance of global and region-specific medical/technical global content documents used for product inquiries from internal customers such as country affiliate staff, and from external customers including healthcare professionals (e.g., External Experts, physicians, pharmacists, nurses, etc.) and consumers.
· Provides timely and accurate development of GCs, summarizes literature and clinical guidelines, and assists in the development/approval of Data on File in accordance with established policies and practice standards. Ensures content conveys a clear and appropriate medical message. Provides review and approval of medical content, including complex and sensitive information. Ensures compliance with regulatory and corporate requirements.
· Able to evaluate data, and maintain an in-depth understanding of product knowledge, associated disease states, treatment guidelines, labeling, and relevant internal data for assigned therapeutic area.
· May partner with internal colleagues to ensure creation of relevant core content to meet customer needs.
· Assists in providing solutions to deliver medical information to customers in unique and innovative ways.
· Critically evaluates literature, interprets complex data, and adapts delivery of information to a variety of audiences.
· Identify global medical information insights based on Medical Information inquiries.

Essential Skills/Abilities
· Must be self-motivated, highly organized, detail-oriented and able to multitask with delivering high quality work.
· Mastery of use of computer systems, database, and software applications, including Microsoft Office, Excel, PowerPoint and knowledge of medical information’s inquiry repository, such as Veeva Vault and Salesforce preferred.
· Ability to coordinate and lead multidisciplinary and cross-functional meetings. Must possess excellent interpersonal, communication, and leadership skills.
· Understanding of the legal and regulatory environment of pharmaceutical industry desired.
· Possesses strong teamwork attributes and cultural sensitivity.
· Must possess excellent oral and written English communication skills. Medical writing skills highly desired.
· Maintains expert understanding of product knowledge, labeling, and relevant data. Able to apply knowledge across multiple therapeutic areas.
· Solid clinical understanding of disease states and the implications of treatment. Strong knowledge of clinical trial methodology, statistical concepts, and independent evaluation and interpretation of complex literature.

Qualifications (education and experience)
· Bachelor’s degree and graduation from an accredited Nursing, PA, Pharmacy, PhD in Health Sciences, or MD/DO program.
· Advanced degree preferred.]]> Mon, 16 Mar 2026 00:00:00 EDT 1

Provides administrative support for specific tasks within a specified department or departments.

 Support may include: data entry, coordination of conference rooms and meetings, travel arrangements, records retention and file management, inputting and tracking purchase orders, and invoices through the internal system, ordering and managing departmental supplies, expense report reconciliation, training class support, and general staff support.

Performs all Company business in accordance with all regulations and Company policy and procedures. Demonstrates high ethical and professional standards with all business contacts and BIPI employees in order to maintain the Company's excellent reputation within the medical and pharmaceutical community.
Skills:    

• Proficient in MS Word, Excel, powerpoint, and Outlook. Excellent written and verbal communication skills. Strong attention to detail and organizational skills. High degree of initiative, accountability, accuracy, problem solving ability and follow-up skills. Strong customer service skills and the ability to maintain confidentiality.
• Expereince with the following software:
  • SAP (In particular for PO creation)
  • Concur 
  • Docusign 

Education:    

• Bachelors Degree and 2-5 years of experience    

Pay Rate Range: $20-27/hr depending on experience ]]> Fri, 13 Mar 2026 00:00:00 EDT 1 Job Description: 
The Scientist will join our Pharmaceutical Development group. The Scientist will be primarily working on semi-solid dosage formulations, and the corresponding characterization works including HPLC, viscometer and other wet chemistry techniques. Candidate should be comfortable multitasking across projects and disciplines.
• Formulation compounding and process development including material handling/weighing, heating, mixing, filling, sealing, packaging and sample shipment, etc.
• Sample preparation and performs physicochemical characterizations, including pH, viscosity, microscopic imaging, rheological measurement, in vitro drug elections, HPLC, etc.
• Laboratory notebook GXP documentation and data summary • Follow instructions and execute studies according to DOE
• Familiar and follow lab safety rules/SOPs

Requirements
Minimum 3 years of experience in any or all of the following:
• Formulation compounding process
• Drug formulation/drug delivery
• Analytical chemistry including HPLC, pH, viscosity measurement Fluent user of Microsoft Office package Understands and utilizes microscope and viscometer Understands and creates GXP documentation DOE = design of experiment HPLC = high performance liquid chromatography GXP = good laboratory and/or manufacturing practices Minimum BS (advanced degrees preferred) in Chemistry/Biochemistry or other relevant scientific fields.

Pay $38-48.65/hr based on experience 
]]> Fri, 13 Mar 2026 00:00:00 EDT 1 Automation Architect (Lead)
Location: Japan
Japanese language skills are not mandatory.

Overview
A leading global pharmaceutical manufacturer is seeking an experienced Automation Architect (Lead) to support a major greenfield OSD manufacturing facility project in Japan.

This role will lead automation architecture, integration strategy, and technical implementation across process, utilities, and building infrastructure systems within a regulated GMP environment.

Key Responsibilities

• Lead technical implementation of automation systems with deep understanding of user and interface requirements
• Define automation architecture aligned with enterprise standards and broader systems landscape
• Drive continuous improvement initiatives within automation systems
• Develop and enhance automation concepts, standards, and migration strategies
• Support commissioning and project execution activities
• Ensure full lifecycle management of automation systems
• Design automation architecture integrating multiple systems, including IT interfaces
• Develop, review, and maintain technical SOPs, business applications, standards, and functional specifications
• Coordinate internal teams and external vendors/partners
• Provide technical analysis and support for complex automation challenges
• Oversee automation governance, standards, and architectural consistency

Required Experience & Skills

• 10+ years’ experience leading automation architecture within large-scale pharmaceutical CapEx projects
• Proven experience delivering major investment projects in regulated manufacturing environments
• Strong hands-on integration experience across multiple automation platforms (e.g. PLC, HMI, SCADA, DCS systems)
• Solid experience in Building & Infrastructure systems (utilities, HVAC, AHU) and Process/Factory Automation frameworks
• Strong understanding of communication protocols (e.g. OPC UA, Bacnet, Profinet, MTP, MSI)
• Experience integrating OT systems with IT layers (e.g. historian systems, MES platforms)
• Deep knowledge of automation framework design, testing strategy, lifecycle management, and compliance in cGMP environments
• Strong understanding of GxP, Computer System Validation (CSV), and regulatory requirements
• Experience in solution architecture design and process optimisation
• Excellent stakeholder management, analytical thinking, and risk management capability
• Strong documentation and governance experience

]]> Fri, 13 Mar 2026 00:00:00 EDT 1 Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.

• Applies job skills and company's policies and procedures to complete a variety of tasks.
• Running test samples for In-Process, Lot Release and Stability studies.
• Running test samples for (but not limited to) investigations, transfers and validations.
• Reviewing assays
• Training others
• Has experience with: Change Control, Deviations, CAPAs, Tasks, EICRs, Investigations.
Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
• Projects - such as method transfers, new instruments, method qualifications
• Use of Microsoft Suites (Word, Excel, PowerPoint)
• Use of Laboratory computer systems
• Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
• Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
• Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Apply Data Integrity principles in all aspects of work, in compliance with DI policies, guidelines and procedures.
• Perform other duties as assigned.
• Strong ability to speak publicly.
• Strong ability to interpret data both alone and with guidance.
• Perform assigned, complex and/or varied tasks.
• Prioritization and problem solving.
• Comprehend and follow instructions.
• Direct, control and plan tasks/projects.
• Brainstorming
• Strong ability to communicate in both written and verbal format .
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Self-motivated team player
• Completes assignments on-time and accurately
• Displays commitment to quality and performs job functions to the best of his/her ability
• Relate to others in a team setting.
• Maintain positive attitude in a team environment.
• Timeliness in completing assigned tasks.
• Works entire assigned shift, including arriving on time

Has experience with or currently uses the following software:
SoftmaxPro, Empower, SoloVPE
Has experience with software validations including but not limited to: writing GMP procedures and validation documents and executing test scripts.
Acts as a SME for at least one software system
Communicates with cross functional teams to interpret needs and priorities.
Has GMP experience within the pharmaceutical industry
Can perform technical, root-cause analysis for some software errors
Applies Data Integrity principles in all aspects of work, in compliance with DI policies, guidelines and procedures.
Remains up to date on all assigned training activities.
Performs other duties as assigned.

Associates Degree Microbiology, Biochemistry or Related Science Fields

Pay ranges between 25-33/hr based on experience ]]> Fri, 13 Mar 2026 00:00:00 EDT 1
Area Sales Manager – Surgical Heart | London
This is a rare chance to step into a newly created role within a fast?growing cardiovascular business as they expand their UK offering with a brand?new Surgical Heart therapy. With early UK cases already underway, they’re now building a specialist commercial team—starting with a high?calibre Area Sales Manager to cover the London region.

If you’re commercially sharp, clinically credible, and motivated by being part of a product launch rather than inheriting a mature territory, this role is built for you.

---

The Opportunity
You’ll be the go?to expert for Surgical Heart solutions across London, working side?by?side with cardiac surgeons, theatre teams, and hospital stakeholders. You’ll shape growth in one of the most strategically important regions in the UK.

You’ll also collaborate with an established UK commercial organisation—already active in TAVI and Coronary therapies—while helping to put this new portfolio firmly on the map.

This is not “just another sales role.” It’s early-stage market development with the backing of a sizeable UK team and the momentum of recent clinical success.

---

What You’ll Be Doing

• Leading commercial activity for a newly introduced Surgical Heart therapy across London
• Partnering closely with surgeons and clinical teams to support cases, education, and hands-on product engagement
• Building long-term relationships across key NHS and private cardiac centres
• Identifying growth opportunities and shaping local strategy
• Working collaboratively with national sales leaders and clinical specialists
• Providing market insight to support wider UK expansion

---

What You Bring

• First experience in medical device sales
• Essential: direct, hands-on experience selling Surgical Heart technologies
• Experience working for a major cardiovascular manufacturer
• Strong clinical presence—comfortable supporting procedures and engaging surgeons
• Self-driven, strategic, and energised by new product introductions

  ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Position: Sales Representative – Orthopaedic Division
Location: Sweden
Type: Full-time | Field-Based


Own Your Territory. Grow Your Career.
We’re looking for a results-oriented sales professional ready to take charge of a high-potential territory. You’ll be the face of our orthopaedic solutions, driving growth, building networks, and making things happen. If you thrive on autonomy and performance, this is your launchpad.
Your Mission

• Hit and exceed sales targets for hip and knee implants
• Manage hospital accounts and distributor relationships
• Navigate pricing, reimbursement, and procurement processes
• Stay sharp on competitor moves and market dynamics

Your Profile

• 2+ years of recent orthopaedic sales experience
• Strong negotiation and relationship-building skills
• Self-starter with a hunger for success

What’s in It for You

• Uncapped growth potential
• High-impact role with regional visibility
• Performance-driven rewards and recognition

 ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Top 3 technical  skills that are required for the role:

1. Strong Background in Quality Systems related to Supplier Controls
2. Proven Excellence in Problem Solving - DMAIC, CAPA, or similar
3. Experience in SAP, Agile, and Track Wise (Nice to Have)

Education Required: Bachelor's Degree and 4 years of relevant experience OR advanced degree with a minimum of 2 years relevant experience

Responsibilities may include the following and other duties may be assigned.

·         Ensures that suppliers deliver quality parts, materials, and services.

·         Leads cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.

·         Lead and/or participate in corrective/preventive action teams in resolving supplier-related issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.). 

·         Coaches team members on supplier quality principles, quality system requirements, statistical analysis, and application of technical analysis to daily assignments.

·         Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.

·         Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.

·         Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

·         Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.

·         Provides technical guidance and quality compliance for Supplier Quality engagement throughout the product’s lifecycle. Including implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.

·         Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.

·         Define Receiving Inspection requirements as required and associated test method validation for internal companyTest Methods.

·         Evaluates and acts as a lead in processing and approving supplier change requests.

·         Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.

·         Supports internal and external audit and inspections, including preparation and resolution of audit and inspection findings

·         Collaborates cross-functional with internal stakeholders and interacts with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.
]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions: • Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, always ensuring patient safety comes first.
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
Knowledge, Skills and Abilities: • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment





  Pay Rate Range: $20 - $29.08  ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions: • Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, always ensuring patient safety comes first.
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
Knowledge, Skills and Abilities: • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment





  Pay Rate Range: $20 - $29.08  ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Essential Functions: • Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, always ensuring patient safety comes first.
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.
Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
• Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).
Knowledge, Skills and Abilities: • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
• Demonstrated ability to exercise discretion and sound judgement
• Good decision-making, negotiation and influencing skills
• Good communication skills and English fluency will be an advantage
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment





  Pay Rate Range: $20 - $29.08  ]]> Thu, 12 Mar 2026 00:00:00 EDT 1 Additional position details from the manager below:

1. Can you please confirm your top 3 skills sets required?
   1. Bachelor’s degree in engineering, science, or related discipline
   2. Strong written and verbal com-munication skills with ability to work as part of a cross functional team
   3. Experience with post market complaints, trending, issue escalation
   4. Nice to have: experience with reliability testing and/or design verification
2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?
   1. Post market complaint investigation including regulatory request responses
   2. Managing issue escalations for post market products
   3. Updating/maintaining risk files
3. What is your target years of experience?
   1. 1-3 years

Responsibilities may include the following and other duties may be assigned. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Designs studies to investigate specific life science questions within field of expertise. May be involved in product research and development and/or clinical trials. Translates research discoveries into usable and marketable products. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience]]> Wed, 11 Mar 2026 00:00:00 EDT 1 Job Title: Practice Development Manager - London
Location: London/South East 
Employment Type: Permanent

Description Role Overview
Reporting to a senior regional commercial leader, the Practice Development Manager role is responsible for supporting an established customer base through the delivery, development, and coordination of product and clinical education for both new and existing clients. The role ensures training is delivered in line with internal standards while maintaining a high level of ongoing customer care.

This position also contributes to customer-facing marketing initiatives and focuses on building trusted, long-term relationships that help clients maximize performance outcomes. Responsibilities span the planning, execution, and ongoing management of account-based initiatives, with a particular emphasis on driving usage and distribution of consumable products within the assigned portfolio.
Territory Scope

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  Candidates must be based within the UK, with London as the primary location
  
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  Regular regional travel is required, including overnight stays, attendance at industry events, and participation in internal meetings and training sessions
  
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  Occasional short-notice travel outside the assigned territory may be necessary
  
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  A full, valid driving licence is required
  

Key Responsibilities

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  Meet or exceed defined sales and utilization targets within the assigned territory, with a focus on increasing customer engagement and product usage
  
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  Deliver hands-on clinical education to customers across a range of aesthetic and energy-based treatments
  
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  Maintain consistent communication with existing clients to track performance and provide continuous clinical guidance and support
  
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  Develop strong customer relationships through onsite visits, delivering product education, clinical instruction, and staff presentations that support sales and marketing effectiveness
  
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  Advise customers on marketing approaches, including digital campaigns, website and microsite development, branding strategies, customer segmentation, and sales methodologies
  
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  Support and participate in regional events such as workshops, open days, and customer engagement activities within the territory
  
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  Conduct and support product demonstrations at industry events and internal training facilities
  
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  Collaborate closely with regional sales colleagues to identify opportunities and address customer needs
  
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  Manage administrative responsibilities, including CRM updates, business planning, expense reporting, forecasting, and regular account performance tracking
  
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  Contribute to cross-functional projects as required, ensuring tasks are completed on time and within budget
  
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  Undertake additional duties as reasonably required
  

Qualifications Essential Experience & Skills

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  Clinical or medical background, or demonstrable experience in a medical aesthetics environment
  
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  Degree-level education or equivalent professional experience
  
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  Certified and competent in operating laser and radiofrequency-based equipment on live patients
  
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  Background in aesthetics, beauty therapy, skin therapy, or a closely related field
  
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  Working knowledge of human and skin anatomy
  
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  Three to five years’ experience in a field-based sales, training, or marketing role
  
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  Strong communication skills, both verbal and written, with confidence presenting to groups
  
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  Proven ability to build credibility and influence customer decision-making
  
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  Adaptable, proactive, and able to manage multiple priorities in a fast-paced environment
  
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  Highly organized with strong attention to detail
  
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  Solid understanding of marketing principles, including traditional, digital, and in-practice strategies
  
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  Customer-focused, consultative approach with a strong service mindset
  

Desirable Experience

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  Previous experience working within an aesthetic or clinical practice
  
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  Exposure to the medical device or healthcare technology sector
  

 ]]> Wed, 11 Mar 2026 00:00:00 EDT 1
Ensures freight is processed efficiently to maximize product service levels. Processes orders, prepares packing lists, packages outgoing materials, takes care of shipping logistics, and ensures the accuracy and timeliness of incoming and outgoing orders. Tracks shipment details, locations, and estimated time of arrivals.

5-10 Years Experience

Pay ranges between 25-30/hr based on experience ]]> Wed, 11 Mar 2026 00:00:00 EDT 1 Tue, 10 Mar 2026 00:00:00 EDT 1 Analyzes, develops, and implements long-term supply chain strategies and networks that address capacity issues and production location decisions in support of business goals.
Supports business execution of new programs and initiatives that include promotional activities, forecast and coordination for key events, new product launches, and network redesigns.
Monitors key sales and operations planning performance indicators, cost-to-serve performance data, and coordinates cross-functional work teams to increase effectiveness of supply chain initiatives.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties .
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Tue, 10 Mar 2026 00:00:00 EDT 1
Manufacturing and Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, is looking for Engineers to support Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require a solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, product lifecycle management, and operational excellence. They will require an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

Job Responsibilities:
1) Support automation capital project software development testing, commissioning activities etc.
2) Support day to day operations of the plant for automation related issues including on call rotation every 7-8 weeks.
3) Support Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with cross functional teams.
4) Support Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
5) Support Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and  CMDB systems.
6) Ensure compliance to Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
7) As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
8) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Preferred Qualifications:
1) Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
2) Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product plant operations.
3) Has five or more years combined experience with the following automation systems:
o Emerson Delta-V DCS system.
o Rockwell Automation SCADA and PLC Platform.
o ABB Robot and Mitsubishi roller bottle machine
o Emerson Delta-V DCS system.
o Electronic Batch Reporting Systems Design and implementation experience.
o Process Control Network design including network segregation.
o Process Control Systems: Virtual Infrastructure design and implementation.
o System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
o Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.]]> Tue, 10 Mar 2026 00:00:00 EDT 1
This is a hands-on role for a multidisciplinary expert focused on solving the core mechanical challenges at the heart of our next-generation platforms. You will be responsible for concepting, designing, building, and testing novel electro-mechanical, pneumatic, thermal, and fluidic solutions that ensure the ultimate performance, reliability, and longevity of our systems.

The Principal Mechanical Engineer will play a vital role in driving innovation for our next-generation instrumentation. We are looking for someone that exhibits a high degree of motivation, independence, and resourcefulness to help us develop solutions to novel DNA Sequencing and automation challenges in a fast-paced and collaborative environment.

Core Responsibilities
You will lead the end-to-end mechanical design and development of mechanical sub-systems including electro-mechanical, pneumatic, fluidic, and thermal components.
You will collaborate with engineers from other disciplines (electrical, consumables, materials) to define and manage all critical technical interfaces for your module.
You will develop novel mechanisms for automated reagent and flow cell loading, clamping, and sealing, ensuring reliability over repeated use.
You will architect and design thermal control systems, including the specification and integration of heating/cooling elements, sensors, condensation control, and heat management.
You will partner with internal and external simulation experts to guide and validate CFD, thermal, and optical models, using empirical data to refine designs.
You will serve as the primary technical expert for your sub-system during integration, verification, and troubleshooting activities, working directly with the Systems Integration team.
You will lead cross-functional design reviews, driving alignment and resolving technical trade-offs between mechanical design, consumables, materials, and assay requirements.
You will drive the technical execution for sub-systems, manage timelines for your design deliverables, and contribute to the overall project plan.
You will create and maintain all design documentation for your sub-systems, including detailed CAD models, drawings, and specifications.
You will contribute to the technical strategy for the future integrated system, providing data-driven recommendations on architecture and technology choices based on your sub-system's performance.
You will present technical progress, data, and design trade-offs to the broader project team and key stakeholders, clearly articulating the rationale and impact of engineering decisions.

Who You Are: (Required)
You have a PhD in Mechanical Engineering, Bioengineering, or a related discipline with at least 3 years of relevant industry experience; or a Master's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 4 years of relevant industry experience; or a Bachelor's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 7 years+ of relevant industry experience.
You have demonstrated deep, hands-on expertise in the design, development, and testing of complex mechanical, electro-mechanical, and pneumatic systems, preferably for life science or diagnostic instrumentation.
You have demonstrated hands-on expertise in thermal management and the design of precision temperature control systems.
You have experience developing fluidics systems and their interfaces including pumps, valves, tubing, sensors, and material selection.
You possess strong proficiency in 3D CAD software (e.g., SolidWorks) for detailed design and the creation of manufacturing drawings.
You have expertise designing components for a variety of manufacturing processes (e.g., machining, injection molding, 3D printing).
You are a creative and resourceful problem-solver, with the ability to troubleshoot complex issues at the interface of hardware, software, and chemistry.
You are proficient with common machine shop tools, as well as test and measurement equipment; proficient with rapid prototyping technology such as 3D printers, laser cutters, CNC mills/lathes, etc; and
You have a demonstrated level of proficiency with Python, LabVIEW, or similar tools for device control and data acquisition.

Preferred:
You have demonstrated the ability to lead technical projects and mentor junior engineers, providing clear guidance and delegating tasks to achieve project goals.
You have experience using simulation tools (CFD, FEA) to guide design decisions.
You have previously worked on the development of next-generation sequencing (NGS) or other genomics instrumentation.
You have experience working in a regulated product development environment
You have demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non-experts; you excel at problem-solving skills and the ability to work under ambiguous situations.
You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you complete work in a timely, accurate and thorough manner.

Pay ranges between 65-80/hr based on experience ]]> Sat, 07 Mar 2026 00:00:00 EST 1 Summary:

Looking for an engineer specialized in industrial utility systems and plumbing. 

 

Primary responsibilities for role:

• Will design the following system types:
• Steam, Chilled Water, Heating Hot Water, Compressed Air, Natural Gas, and Plumbing

Develop construction documents for industrial and commercial code compliant underground plumbing systems.

Specify technical utility equipment: boilers, chillers, cooling towers, heating hot water skids, air compressors, receivers, tanks, and other parts of the listed system types thru development of user requirements, P&IDs, equipment sizing calculations, equipment specifications and datasheets.

Modify existing or develop new piping, material, and equipment specifications to meet requirements of project scopes.

Perform vendor & bid evaluations, progress monitoring, and attendance of factory acceptance testing.

Field supervision of contractors during construction to ensure safety, quality, and schedule.

Work as part of a multidiscipline team to design, start up and commission new systems.

Provide contractors answers to questions that arise during construction, review/approve component submittals, issue field notices as needed.

Ensure drawings are as-built, document commissioning, prepare turnover package.

Ensure compliance with company, environmental, building code, and regulatory policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.

Analize existing utility systems and infrastructure and reconfigure to support new operations.

Function as site subject matter expert for industrial utility design and construction.

Provide the necessary calculations for all equipment sizing associated with the utility systems.

These new utility systems are to support the FDA licensed blood fractionation, purification, and filling operations. Pharmaceutical experience is not required but shall be considered a plus for the candidate.
 

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

 

Additional Responsibilities:

Meets customer expectations and continuously improves process technology or capital process through improved productivity and quality, in consultation with internal departments and external resources. Maintains awareness of governmental, industry, and academic developments. Usually participates with a technical or industry association external to the company. Works efficiently with people to transfer technology into the business. Transfers knowledge for the good of the corporation. Leads installation, qualification, and integration into process controls of mechanical systems. Develops objectives and implementation plans for a team of engineers. Works with a core team and management to continue to develop and define the approach for the organization. Participates in identification, justification, development, and implementation of strategies and communicates the ideas to the core team. 

 

Knowledge, Skills, and Abilities:

Possesses adequate communication skills necessary in interacting with internal and external customers. Report-writing skills are important to help prepare clear and concise updates to clients and co-workers. Must be computer literate and have knowledge of such software programs as Microsoft Office that is helpful in creating reports, spreadsheets, and system design plans. Must also be well-organized and have the ability to facilitate meetings ensure reports are organized and prepared in advance to present to intended parties. Excellent oral and written communication skills with the ability to present complex ideas in clear and simple terms. Strong problem solving skills. Ability to analyze and identify areas for improvement.

 

Education and Experience:

Bachelor’s degree in engineering or related field from an accredited university and be able to obtain a NC PE license. Other professional registration and/or certifications as appropriate.

Minimum of 6 years of industrial experience. Experience in Biotech or Chemical industry preferred.

Experience designing following system types: Steam, Chilled Water, Heating Hot Water, Compressed Air, Natural Gas, and Plumbing is highly desired

HVAC experience is not required but shall be considered a plus for the candidate.

Direct experience with AutoCAD, PipeFlo, Revit, Plant 3D is not required but will be considered a plus for the candidate.
               

Equivalency:

Depending on the area of assignment, related experience or a combination of related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate’s degree with 6 years of experience, or a master’s degree with 2 years of experience.

 

Occupational demands:

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32°F in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Repetitive foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs.

 
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Location: Japan
Eligibility: Japanese language skills not mandatory Overview
A global pharmaceutical manufacturing organisation is seeking a senior Automation Engineer to support the delivery of a large-scale greenfield OSD facility in Japan.

This role will take ownership of technical implementation across automation systems, ensuring alignment with project standards, system integration strategy, and cGMP compliance requirements. The position will focus on automation architecture, OT/IT integration, and lifecycle management across both process and building infrastructure systems.
Key Responsibilities

• Lead end-to-end technical implementation of automation systems within a large-scale pharmaceutical project
• Define and maintain automation architecture, standards, and governance
• Ensure automation solutions align with enterprise system landscapes and project requirements
• Drive integration between OT and IT systems, including data flow and system interfaces
• Support commissioning, qualification, and start-up phases
• Ensure lifecycle management of automation systems, including migration and upgrade strategies
• Coordinate cross-functional stakeholders including engineering, QA, validation, and external vendors
• Ensure compliance with cGMP, CSV, and regulatory requirements
• Identify and drive continuous improvement opportunities within automation frameworks

Candidate Profile

• 7+ years of relevant automation engineering experience
• Experience delivering automation systems within pharmaceutical manufacturing environments
• Strong knowledge of automation architecture and system integration
• Experience working within regulated (cGMP) environments
• Strong stakeholder coordination and communication skills
• Hands-on technical capability combined with architectural oversight experience

]]> Thu, 05 Mar 2026 00:00:00 EST 1

Design, develop, and execute functional genomics assays, including CRISPR-based editing (e.g., RNP delivery, Perturb-seq), single-cell sequencing, spatial transcriptomics, and CITE-seq.

Provide technical guidance and training to research scientists on FGSL technologies and techniques, including assay execution, troubleshooting, and resolution of technical issues;

Documents and maintains detailed laboratory records in accordance with policies;

Operates and maintains lab equipment in collaboration with other lab members;

Assists acquisition of necessary supplies and equipment;

Defines and performs appropriate QC measures; 

Follows relevant scientific literature to ensure use of optimal methods and understand emerging practices across the field;

Demonstrates the ability to interpret the outcome of experiments, propose appropriate follow-up, and may propose new avenues of investigation;

Communicates own work effectively orally and in writing; contributes to writing protocols, procedures, and technical reports

Automate processing and results reporting and delivery;

Reports and treats data with a high level of integrity and ethics.  Skills:    

• CRISPR assays - Must have personally designed guides, performed transfections/infections, selected edited cells, and validated knockouts/knockins
• Next-generation sequencing (NGS) - Hands-on library preparation experience (not just data analysis)
• Single cell technologies - Personal experience with sample prep, library generation, and quality control
• Standard molecular biology techniques - qPCR, Western blot, cloning, gel electrophoresis
• Cell culture - Proficient in maintaining multiple cell lines, transfections, and sterile technique
• Experience in automation is a plus;
• Able to perform variety of FGS experimental techniques at the same time;
• Demonstrated experience working in a multi-disciplinary and collaborative environment;
• Ability to troubleshoot FGS experiments both individually and as part of a team.
• Excellent oral and written skills with the ability to communicate in an open, transparent, timely and consistent manner.

Education:    

• Master’s degree from an accredited institution with 4+ years of experience in molecular, cell biology, or related scientific discipline.

Pay Rate Range: $35-49/hr depending on experience ]]> Thu, 05 Mar 2026 00:00:00 EST 1

We’re supporting a global medical devices organisation in the search for an Area Sales Manager to drive growth across the Madrid region. This role focuses on a leading portfolio in knee and hip reconstruction, working closely with surgeons, clinical teams, and hospital stakeholders to expand market presence and deliver exceptional customer support.
What you’ll do

• Own commercial performance across the Madrid territory with full responsibility for sales growth and account development.
• Build strong, long-term relationships with orthopaedic surgeons, operating theatre teams, procurement, and hospital decision-makers.
• Deliver product expertise across the knee and hip replacement portfolio, providing in-theatre support, training, and case coverage.
• Identify new business opportunities, develop territory plans, and execute strategies to increase market share.
• Lead product evaluations, support clinical education programmes, and ensure a best?in?class customer experience.

What we’re looking for

• Proven track record in orthopaedics, ideally in joint reconstruction (knee/hip).
• Strong commercial acumen with experience managing a high-volume hospital territory.
• Confident communicator with the ability to influence clinical and procurement stakeholders.
• Self-driven, organised, and experienced in building a sustainable pipeline.
• Based in Madrid with the ability to travel across the region.

What’s on offer

• A highly visible role within a fast?growing orthopaedics business.
• Competitive package with performance-based incentives.
• Strong career progression and continuous training within an innovative portfolio.

]]> Tue, 03 Mar 2026 00:00:00 EST 1 Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

Essential Functions: • Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
• General Support:
• Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as requested.
• Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
Clinical Trial Support:
• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
• Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
• Marketed Products Support:
• Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
• Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.

Education and Experience:
• MD board certified in Rheumatology
• Candidates should have at least one of the following: Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years); Or Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or direct experience in safety/Pharmacovigilance (comparable to 2 years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities: • Therapeutic expertise in Rheumatology
• Strong decision-making, problem solving, organizational skills and analytical skills
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases (e.g. Medra)
• Flexibility to travel domestically and internationally
• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
• Proficiency in basic computer applications
• Fluent in spoken and written English
• Excellent interpersonal, influencing and team building skills
• Understanding guidelines (FDA, ICH, EMA and GCP)
• Working knowledge of biostatistics, data management, and clinical operations procedures
• Ability to act as a mentor/trainer to other staff



Pay Rate Range: $150-$170/hr depending on experience ]]> Tue, 03 Mar 2026 00:00:00 EST 1 Prywatna siec klinik specjalizujacych sie w leczeniu chorob nerek poszukuje lekarza do pracy w placowce w Mlawie. Rola obejmuje kompleksowa opieke nad pacjentami z przewlekla choroba nerek, scisla wspolprace z zespolami medycznymi oraz realizacje nowoczesnych standardow leczenia.

Rozwazani beda lekarze:

• Nefrolodzy (preferowani)
• Interneci ze specjalizacja w kardiologii, diabetologii lub gastroenterologii

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Zakres odpowiedzialnosci Kompleksowa opieka nad pacjentem

• Prowadzenie pacjentow na wszystkich etapach przewleklej choroby nerek
• Tworzenie i nadzor nad indywidualnymi planami leczenia
• Kwalifikacja do dializ, wybor odpowiedniej metody oraz optymalizacja farmakoterapii zgodnie z aktualnymi wytycznymi
• Edukacja pacjentow w zakresie samoopieki, profilaktyki i zmiany stylu zycia

Dzialania diagnostyczne i profilaktyczne

• Ocena czynnikow ryzyka oraz monitorowanie pacjentow dializowanych
• Planowanie i zlecanie badan diagnostycznych oraz interpretacja wynikow
• Informowanie pacjenta o dostepnych opcjach terapeutycznych

Wspolpraca wielospecjalistyczna

• Bliska wspolpraca z pielegniarkami, dietetykami, psychologami i personelem technicznym
• Wdrazenie nowoczesnych rozwiazan terapeutycznych w codziennej praktyce

Wklad w jakosc leczenia

• Stabilizowanie stanu pacjentow
• Zmniejszanie liczby hospitalizacji
• Podnoszenie jakosci zycia pacjentow na co dzien

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Wymagania Kwalifikacje medyczne

• Preferowana specjalizacja z nefrologii
• Alternatywnie: choroby wewnetrzne z podspecjalizacja kardiologiczna, diabetologiczna lub gastroenterologiczna
• Uprawnienia do prowadzenia terapii pacjentow nefrologicznych

Rejestracja i zgodnosc

• Rejestracja lub mozliwosc rejestracji w Polsce
• Mozliwosc uzyskania numeru NFZ
• Brak karalnosci i pozytywna historia zawodowa
• Biegla znajomosc jezyka polskiego
• Otwartosc na kandydatow z zagranicy, pod warunkiem spelnienia wymogow formalnych

]]> Mon, 02 Mar 2026 00:00:00 EST 1 Prywatna siec klinik specjalizujacych sie w leczeniu chorob nerek oraz dializoterapii poszukuje Lekarza Kierujacego do prowadzenia pracowni dializ oraz zarzadzania praca zespolu medycznego. Rola laczy odpowiedzialnosc kliniczna z zadaniami administracyjnymi i organizacyjnymi, zapewniajac wysoki standard opieki nad pacjentami z przewlekla niewydolnoscia nerek.
Zakres odpowiedzialnosci Opieka kliniczna

• Prowadzenie konsultacji oraz kwalifikacja pacjentow do terapii nerkozastepczej
• Planowanie i realizacja diagnostyki, w tym zlecanie i interpretacja badan dodatkowych
• Prowadzenie dzialan profilaktycznych, ocena czynnikow ryzyka i monitorowanie stanu zdrowia pacjentow dializowanych
• Przygotowywanie pacjentow do zaplanowanej formy terapii nerkozastepczej oraz omawianie wskazan i przeciwwskazan
• Przygotowanie pacjentow do transplantacji zgodnie z obowiazujacymi procedurami

Zarzadzanie i administracja

• Nadzor nad praca zespolu medycznego oraz organizacja pracy kliniki
• Wsparcie kierownika stacji oraz przejmowanie obowiazkow zarzadczych podczas jego nieobecnosci
• Wspolpraca z zespolami pielegniarskimi i technicznymi w celu utrzymania najwyzszych standardow jakosci
• Dbanie o zgodnosc dzialan kliniki z procedurami i standardami organizacji

Dzialania rozwojowe

• Udzial w programach badawczych realizowanych w jednostce
• Wsparcie inicjatyw edukacyjnych dla personelu medycznego

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Wymagania Kwalifikacje

• Specjalizacja z nefrologii (preferowana) lub chorob wewnetrznych
• Kwalifikacje do samodzielnego prowadzenia terapii nerkozastepczej

Rejestracja i formalnosci

• Prawo wykonywania zawodu w Polsce lub mozliwosc uzyskania rejestracji
• Mozliwosc rejestracji w NFZ
• Niekaralnosc i czyste sprawdzenie weryfikacyjne
• Biegla znajomosc jezyka polskiego
• Otwartosc na kandydatow z zagranicy spelniajacych wymogi formalne

]]> Mon, 02 Mar 2026 00:00:00 EST 1 Prywatna siec klinik specjalizujacych sie w leczeniu chorob nerek i dializoterapii poszukuje doswiadczonego Lekarza Kierujacego – Nefrologii, ktory obejmie nadzor medyczny nad zespolami lekarskimi w placowkach na terenie Polski. Rola laczy kompetencje kliniczne z funkcja zarzadcza, zapewniajac wysoka jakosc opieki nad pacjentami z przewlekla niewydolnoscia nerek.
Zakres obowiazkow
Nadzor medyczny

• Koordynacja pracy zespolow lekarskich w roznych lokalizacjach
• Wspieranie wdrazania standardow leczenia i procedur klinicznych
• Monitorowanie jakosci opieki oraz wynikow leczenia

Opieka nad pacjentem

• Prowadzenie konsultacji specjalistycznych w zakresie nefrologii
• Nadzor nad przygotowaniem pacjentow do dializoterapii i transplantacji
• Wspolpraca z zespolami pielegniarskimi i technicznymi

Dzialania rozwojowe i badawcze

• Udzial w inicjatywach badawczych i projektach rozwojowych
• Wspoltworzenie programow edukacyjnych dla personelu medycznego
• Reprezentowanie placowek w kontaktach z instytucjami medycznymi i regulacyjnymi

Wymagania
Wyksztalcenie i doswiadczenie

• Specjalizacja z nefrologii (preferowana) lub chorob wewnetrznych
• Doswiadczenie kliniczne oraz w zarzadzaniu zespolami medycznymi

Rejestracja i zgodnosc

• Prawo wykonywania zawodu w Polsce i mozliwosc rejestracji w NFZ
• Niekaralnosc i pozytywna historia zawodowa
• Biegla znajomosc jezyka polskiego

]]> Mon, 02 Mar 2026 00:00:00 EST 1
• Operates CNC mills and lathes, Riveters, Surface finishing machines, and Buffering machines to manufacture mold pins and assemble mold bars.
• Performs routine maintenance of machines including lubrication and changing tooling.
• Performs washing and assembly operations.
• Inspects pin and bar stock, mold pins and assembled bar pins using visual inspection, gauges, micrometers, and other precision measuring equipment.
• Repairs and straightens mold bars.
• Packages assembled bars for shipment to customers.
• Responsible for the quality of mold pins and mold bars, including notifying the mold manufacturing technician group leader of quality or machine problems.
• Must be able to work 40 hours a week, which may include weekends, holidays, etc.
• Must be able to work additional hours/days as business needs dictate.
• Attendance in the plant site is considered an essential function.
• Perform other duties as assigned.

The max pay rate is $17.66/hr for this ppsotion ]]> Mon, 02 Mar 2026 00:00:00 EST 1 Nephrology / Internal Medicine – Clinical & Managerial Role

Prywatna siec klinik leczenia chorob nerek oraz dializoterapii poszukuje Head Physician do kierowania praca placowki w Kostrzynie nad Odra. Rola laczy codzienne obowiazki kliniczne z zarzadzaniem zespolami medycznymi i nadzorem nad funkcjonowaniem stacji dializ.

---

Zakres odpowiedzialnosci Opieka kliniczna

• Prowadzenie konsultacji oraz kwalifikacja pacjentow do terapii nerkozastepczej
• Planowanie diagnostyki, zlecanie i interpretacja badan dodatkowych
• Ocena czynnikow ryzyka, monitorowanie stanu zdrowia pacjentow dializowanych
• Przygotowywanie pacjentow do odpowiedniej formy terapii oraz omawianie wskazan, przeciwwskazan i ryzyk
• Przygotowywanie pacjentow do transplantacji zgodnie z obowiazujacymi procedurami

Zarzadzanie i administracja kliniki

• Nadzor nad praca zespolu medycznego w placowce
• Wsparcie operacyjne i organizacyjne funkcjonowania stacji dializ
• Zapewnienie zgodnosci z procedurami medycznymi i organizacyjnymi
• Wspolpraca z zespolami pielegniarskimi, technicznymi i administracyjnymi
• Reprezentowanie placowki w kontaktach wewnetrznych i zewnetrznych

Dzialania rozwojowe

• Udzial w programach badawczych realizowanych w jednostce
• Wspoltworzenie inicjatyw edukacyjnych dla personelu medycznego

---

Wymagania Kwalifikacje

• Specjalizacja z nefrologii (preferowana) lub chorob wewnetrznych
• Uprawnienia do prowadzenia terapii nerkozastepczej

Rejestracja i zgodnosc

• Rejestracja lub mozliwosc rejestracji w Polsce
• Mozliwosc uzyskania numeru NFZ
• Brak karalnosci i pozytywna historia zawodowa
• Biegla znajomosc jezyka polskiego
• Otwartosc na kandydatow z zagranicy spelniajacych wymogi formalne

]]> Mon, 02 Mar 2026 00:00:00 EST 1 Clinical Role with Multidisciplinary Collaboration

Prywatna siec klinik specjalizujacych sie w leczeniu chorob nerek poszukuje lekarza do kompleksowej opieki nad pacjentami z przewlekla choroba nerek – od wczesnych etapow schorzenia, przez niewydolnosc kra?cowa, az po monitorowanie powiklan narzadowych.

Rozwazani beda lekarze:

• Nefrolodzy (preferowani)
• Interneci ze specjalizacja w kardiologii, diabetologii lub gastroenterologii

---

Zakres odpowiedzialnosci
Opieka nad pacjentem

• Prowadzenie pacjentow z przewlekla choroba nerek na kazdym etapie leczenia
• Nadzor nad indywidualnymi planami terapii: kwalifikacja do dializ, wybor formy leczenia, optymalizacja farmakoterapii zgodnie z aktualnymi wytycznymi
• Przygotowanie pacjentow do terapii nerkozastepczej oraz omawianie wskazan, przeciwwskazan i ryzyk
• Edukacja pacjentow w zakresie samoopieki i modyfikacji stylu zycia

Dzialania diagnostyczne i profilaktyczne

• Ocena czynnikow ryzyka oraz monitorowanie stanu pacjentow dializowanych
• Planowanie diagnostyki, zlecanie badan i interpretacja wynikow
• Konsultowanie dostepnych opcji terapeutycznych

Wspolpraca zespolowa

• Scisla wspolpraca z pielegniarkami, dietetykami, psychologami oraz personelem technicznym
• Wdrazenie nowoczesnych rozwiazan terapeutycznych i standardow opieki

Cel roli

• Poprawa rokowania pacjentow
• Zmniejszenie liczby hospitalizacji
• Stabilizacja stanu zdrowia
• Podniesienie jakosci zycia pacjentow na codzien

---

Wymagania
Kwalifikacje

• Preferowana specjalizacja: nefrologia
• Akceptowane specjalizacje dodatkowe: kardiologia, diabetologia, gastroenterologia
• Uprawnienia do prowadzenia terapii pacjentow nefrologicznych

Rejestracja i zgodnosc

• Rejestracja lub mozliwosc rejestracji w Polsce
• Mozliwosc uzyskania numeru NFZ
• Brak karalnosci i czyste sprawdzenie weryfikacyjne
• Biegla znajomosc jezyka polskiego
• Otwartosc na kandydatow z zagranicy spelniajacych wymogi formalne

]]> Mon, 02 Mar 2026 00:00:00 EST 1 Prywatna siec klinik specjalizujacych sie w leczeniu chorob nerek i dializoterapii poszukuje doswiadczonego Lekarza Kierujacego – Nefrologii, ktory obejmie nadzor medyczny nad zespolami lekarskimi w placowkach na terenie Polski. Rola laczy kompetencje kliniczne z obowiazkami zarzadczymi, zapewniajac wysoki standard opieki nad pacjentami z przewlekla niewydolnoscia nerek.
Zakres obowiazkow
Nadzor medyczny

• Koordynacja pracy zespolow lekarskich w roznych lokalizacjach
• Wspieranie wdrazania standardow leczenia i procedur klinicznych
• Monitorowanie jakosci opieki i wynikow leczenia

Opieka nad pacjentem

• Prowadzenie konsultacji specjalistycznych w zakresie nefrologii
• Nadzor nad przygotowaniem pacjentow do dializoterapii i transplantacji
• Wspolpraca z zespolami pielegniarskimi i technicznymi

Dzialania rozwojowe i badawcze

• Udzial w projektach rozwojowych i inicjatywach badawczych
• Wspoltworzenie programow edukacyjnych dla personelu medycznego
• Reprezentowanie placowek w kontaktach z instytucjami medycznymi i regulacyjnymi

Wymagania
Wyksztalcenie i doswiadczenie

• Specjalizacja z nefrologii (preferowana) lub chorob wewnetrznych
• Doswiadczenie kliniczne oraz w zarzadzaniu zespolami medycznymi

Rejestracja i zgodnosc

• Prawo wykonywania zawodu w Polsce i mozliwosc rejestracji w NFZ
• Niekaralnosc i pozytywna historia zawodowa
• Biegla znajomosc jezyka polskiego

]]> Mon, 02 Mar 2026 00:00:00 EST 1
Key Responsibilities

• Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs
• Support weekend lab operations and maintain training records
• Assist in lab equipment and inventory maintenance, including reagent and sample prep Review data timely and qualify as a data reviewer
• Perform operational assignments (raw material processes, environmental monitoring, in-process testing)
• Contribute to updating controlled documents (SOPs, work instructions, test methods)
• Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH)
• Participate in continuous improvement initiatives and cross-functional collaboration
• Support regulatory submissions, inspection readiness, and audits

Qualifications

• B.S. in chemistry, biology, biochemistry, or related field 4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent
• Experience in method transfer/implementation; understanding of method lifecycle management preferred
• Strong technical writing, data analysis, problem-solving, and organizational skills
• Excellent communication and teamwork Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred

]]> Fri, 27 Feb 2026 00:00:00 EST 1
The Sr. Associate Facilities for a Final Drug Product Operation Facility will be part of the Facilities & Engineering team responsible for providing maintenance leadership and technical expertise in support of safe and reliable facility infrastructure, facility equipment/systems, electrical systems, instrument standards, utility systems, and/or production suites and ensures:
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.
• Supports the efficient operation of site facility infrastructure systems (to include all utility systems, electrical systems, etc.).
• Monitors all system status and analyzes to identify trends.
• Develops maintenance strategies and programs (preventative, corrective, predictive etc.) to ensure cost effective and reliable operation of all plant equipment and systems.
• Facilitates business units' capability to perform their functions.
• Working in a regulated cGxP environment, identifies engineering needs for site facilities.
• Defines projects, develops innovative solutions, determines engineered solutions, develops project documentation, obtains capital or expense resources.
• Represent site as Facilities SME.
• Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures (SOPs).
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to facility equipment/systems.
• Solving complex problems, project management, equipment lifecycle management and operational excellence.
• Drawing management for Facilities and Supporting areas.
• Determining facility and equipment specifications.

Basic Qualifications:
Bachelors degree in Engineering (Mechanical, Electrical or Chemical) + 2 years Engineering and/or Facilities Maintenance work experience.
High school/GED + 8 years Engineering and/or Facilities Maintenance work experience OR
Associates + 4 years Engineering and/or Facilities Maintenance work experience.]]> Thu, 26 Feb 2026 00:00:00 EST 1 Can you please confirm your top 3 skills sets required?

    Data driven problem solving

    Solid understand and application of regulatory requirements

    NCRs, Complaint Investigation, Site Transfers, Site Shutdowns

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

   Day to day sustaining operations quality support

   NCR Ownership

   Complaints DHR and manufacturing assessment

What is your target years of experience?  More than 5 years of mfg/operations experience

 

 
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Thu, 26 Feb 2026 00:00:00 EST 1 ABOUT THE POSITION

The Senior Manager, Supply Chain will be a member of the Supply Chain and Logistics (SCL) Team, reporting to the Director of Supply Chain and Logistics. This individual is responsible for ensuring supply continuity for both research and GMP functions. They will manage a team of materials managers that manage multiple inventories servicing various needs across both internal and external partners. This individual will be vital in assuring that company reaches as many patients as possible by eliminating supply issues before they arise. This individual will also have the opportunity to establish inventory policies and procedures with far-reaching impact. They will be the primary escalation for supply issues and the primary contact for corrective action.


KEY RESPONSIBILITIES

• Supply Chain Management: Develop and implement procurement strategies to balance quality, cost, and supply continuity.
• Inventory Control & Team Management: Manage a team of materials managers who ensure inventory of critical materials is available at all times. 
• Supplier Relations: Establish and maintain relationships with suppliers, negotiate contracts, manage change notifications or updates to material quality and ensure timely delivery of quality materials.
• Cost Management: Analyze market trends to achieve cost reductions while maintaining quality standards.
• Compliance: Ensure all material management activities comply with industry standards and GMP practices where applicable. 
• Lifecycle Management: Identify areas of improvement in our overall supply chain strategy and implement accordingly with guidance from management. 
• Performs other duties as assigned

 

REQUIREMENTS
QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in supply chain management, business administration, an analytical field, or equivalent experience. Master’s in supply chain or MBA is a plus.
• Minimum of 5 years of experience in materials management, supply chain, or related, preferably within the biotechnology or pharmaceutical industry.
• Experience managing a team. 

REQUIRED SKILLS AND ABILITIES

• Proven experience working with multiple parties to complete tasks, including managing competing priorities.
• Excellent organizational and leadership abilities that drive results through delegation.
• Proficiency in Microsoft Office Suite and familiarity with ERP systems, data analytics platforms, and forecasting software
• Experience working with research organizations and contract manufacturers in a GRP/GMP setting.
• Experience working with cellular therapy products, and/or in eye banking a plus.
• CSCP, CPIM, CPSM or CPL a plus.

]]> Tue, 24 Feb 2026 00:00:00 EST 0 • Assist participants with porting their mobile phones to the required platform
• Configure and pair Apple Watch devices with participant mobile phones
• Ensure proper installation of required applications and system settings
• Verify device connectivity, data synchronization, and functionality
• Troubleshoot basic technical issues related to mobile devices and wearables
• Provide clear instructions and guidance to participants on device use
• Document setup completion and any technical issues encountered
• Maintain compliance with data privacy, security, and study protocols
Education and Experience: • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’) or equivalent combination of education, training, & experience.
• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities: • Experience supporting clinical research or healthcare technology environments
• Familiarity with mobile device management (MDM) systems
• Experience working in participant-facing or customer support roles
• Ability to communicate information effectively
• Ability to troubleshoot and resolve issues on mobile phones and watches
• Strong customer service skills
• Ability to multi-task and pay close attention to detail
• Analytical and problem-solving skills



Pay Rate Range: $29.70 - $33 depending on experience ]]> Tue, 24 Feb 2026 00:00:00 EST 1 •Review of event documentation such as Batch records, Exceptions, and Regulatory filings
•Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
•Support design development plan including design verification and DHF deliverables
•Build and maintain Product Specification Files (PSF) for the clients program

Skills
•Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13) 
•Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
•Demonstrated teamwork, initiative, and problem-solving skills
•Ability to prioritize and work independently with minimal supervision
•Ability to accurately determine deadlines and ask for help if needed
•Detail oriented with solid problem solving acumen.
•Ability to work effectively in a team environment with great organization skills.
•Ability to independently analyze and reconcile moderate to complex issues.
•Must have demonstrated initiative and accountability in a fast paced environment.
•Excellent verbal and written communication and interpersonal skills.
•Proficient with computers and word processing software (i.e., Microsoft Office products)

Education
•Minimum, a BS degree in life sciences, engineering or related field
•Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
•To have been involved on a device development project before as QA
•Signed off on design development plan, completed design verification, approved DHF deliverables
•Good understanding of FDA and EMA regulations and guidelines
•Excellent organizational, communication, and interpersonal skills.
•Preferred Quality Drug Substance manufacture experience

Pay ranges between 42-48/hr based on experience ]]> Tue, 24 Feb 2026 00:00:00 EST 1 Scrum Master – Drive Agile Excellence in Cutting-Edge Medical Software

Are you passionate about facilitating agile teams to deliver impactful technological innovations? We’re seeking an experienced Scrum Master to empower a talented software engineering team developing sophisticated embedded systems for surgical environments. Join us in a pivotal role where your leadership and coordination will enable seamless collaboration across multidisciplinary functions, ensuring project success from concept to completion. This is your chance to make a real difference in healthcare technology by guiding teams through dynamic sprints and strategic planning.

What You’ll Need to Succeed:

• Proven experience as a Scrum Master or in a similar Agile facilitation role
• Strong understanding of Scrum, SAFe, or other Agile frameworks
• Excellent stakeholder management and communication skills
• Ability to coordinate across multiple functions including hardware, regulatory, quality assurance, and product teams
• Skilled at organizing PI planning, sprint review, and refinement sessions
• Track record of managing project timelines, dependencies, and deliverables
• Familiarity with software development lifecycle in embedded systems or healthcare technology

Nice to Have Skills:

• Experience with embedded systems or medical device software development
• Knowledge of regulatory compliance processes within the healthcare industry
• Certification such as Certified ScrumMaster (CSM), PMI-ACP, or SAFe Program Consultant (SPC)
• Familiarity with project management tools like Jira or Rally

Preferred Education and Experience:

• Bachelor’s degree in Computer Science, Engineering, or a related field
• Minimum of 3 years experience in software project management or agile team facilitation, preferably within healthcare or embedded systems domains

Other Requirements:

• This role is based in London, UK, with a hybrid working model requiring 2-3 days on-site
• Contract length of 6 months, with a full-time schedule
• Immediate start preferred; strong communication skills and proactive engagement will set you apart

Take the next step in your career by applying now and be part of transforming surgical technology. Your expertise could be the key to delivering life-changing innovations!
]]> Mon, 23 Feb 2026 00:00:00 EST 1 Compliance Manager III - Austria

Are you a seasoned compliance professional ready to make a significant impact in a dynamic, global environment? Join us as a Compliance Manager III, and play a pivotal role in supporting our business strategies through leading key programs and managing critical compliance initiatives. This opportunity offers the chance to work at the forefront of ethics, risk management, and quality assurance, ensuring our operations uphold the highest standards of integrity and excellence.

Overview
As a Compliance Manager III, you will be instrumental in driving the seamless implementation of compliance programs, supporting major projects related to Ethics, Risk, and Quality management within a pharmaceutical setting. Your leadership will encompass project management, SAP/ERP system optimization, and stakeholder engagement, contributing to the reputation and operational excellence of our organization. Located in Austria with a flexible hybrid work arrangement, this role is ideal for a proactive professional eager to influence global initiatives and ensure regulatory and quality compliance across our operations.

Required Skills

• Extensive experience in Quality or IT backgrounds with strong SAP/ERP system knowledge
• Proven expertise in SAP/ERP Environment, particularly SAP QM modules
• Demonstrated project management skills, including establishing project offices, defining scope, timelines, and managing budgets
• Excellent communication skills in English; proficiency in German is highly desirable
• Ability to act as a Subject Matter Expert during audits and inspections
• Proven stakeholder engagement and collaboration capabilities
• Strong organizational skills with the ability to manage multiple initiatives simultaneously

Nice to Have Skills

• Experience working within the pharmaceutical or life sciences industry
• Additional language skills beyond English and German
• Knowledge of incident and enhancement management processes in SAP QM

Preferred Education and Experience

• Bachelor’s or Master’s degree in Quality, IT, or a related field
• Several years of hands-on experience with SAP/ERP systems and project management in a regulated environment
• Prior experience supporting global compliance and quality improvement projects

Other Requirements

• Ability to coordinate and support data extractions, process harmonization, and system implementation activities
• Willingness to collaborate with global teams and engage in cross-functional projects
• Fluency in English; German language skills are advantageous

Take the next step in your compliance career and contribute to impactful projects that uphold our commitment to quality and integrity. If you're ready to lead, influence, and innovate in a collaborative environment, we encourage you to apply now!
]]> Mon, 23 Feb 2026 00:00:00 EST 1 Innovative Principal Software Engineer – Drive Cutting-Edge Medical Technology

Join a visionary team redefining healthcare innovation as a Principal Software Engineer. In this pivotal role, you'll lead the development of sophisticated software solutions for advanced medical devices, working at the intersection of hardware and software to improve patient outcomes globally. Your expertise will shape the future of medical technology, collaborating with multidisciplinary teams to deliver secure, reliable, and compliant systems.

Required Skills:

• Bachelor's or Master’s degree in Computer, Electrical, Electronics Engineering, or a related field.
• Extensive experience developing Linux device drivers (V4L2, I2C, SPI, UART) and tinkering with the Linux kernel and device trees.
• Strong proficiency in C/C++ and shell scripting.
• Demonstrated expertise with Linux system components including kernels, services, and log management.
• Experience working with custom Linux build systems such as Yocto or Buildroot.
• Knowledge of hardware integration, system bring-up, and over-the-air updates.
• Solid understanding of security concepts like hardware root of trust and cryptographic keys.
• Familiarity with Linux diagnostic and benchmarking tools.
• Basic electronics knowledge and ability to interpret schematics and datasheets.
• Excellent communication skills and the ability to solve complex problems independently.

Nice to Have Skills:

• Experience with deployed hardware systems and remote device management.
• Programming expertise in Python.
• NVIDIA computing platforms experience.
• Microcontroller development background.
• Knowledge of AWS cloud services.
• Experience with automated testing, video streaming protocols, camera sensors, and codecs.
• Understanding of security principles relevant to safety-critical systems.
• Prior experience developing software for medical or other safety-critical applications.

Preferred Education and Experience:

• Bachelor’s or Master’s degree in relevant engineering disciplines.
• Proven track record of several years working with embedded Linux systems and hardware integration in a high-tech environment.

Other Requirements:

• Ability to work flexibly within a hybrid setup, with 3 days onsite per week in London.
• Experience in a regulated environment, adhering to security and compliance standards for medical devices.
• Willingness to participate in formal risk analysis, verification, and design transfer activities.

Take this opportunity to lead innovative projects that make a real difference in healthcare. If you're passionate about pushing technological boundaries and delivering impactful medical solutions, we want to hear from you—apply now and be part of the future of medical technology development!
]]> Mon, 23 Feb 2026 00:00:00 EST 1 Senior Software Engineer – Innovate at the Forefront of Medical Technology

Join a dynamic team pushing the boundaries of healthcare innovation as a Senior Software Engineer. In this pivotal role, you'll develop and enhance cutting-edge intra-operative devices that save lives and improve patient outcomes. Collaborate with multidisciplinary experts in a fast-paced environment to deliver robust, secure, and reliable software solutions that make a real difference worldwide.

What You’ll Bring:

• A BS/MS in Computer, Electrical, Electronics Engineering, or a related field.
• Proven experience developing high-quality, high-performance code in modern C++ (C++17 or higher).
• Strong expertise working within Unix/Linux environments.
• Hands-on experience with inter-process communication frameworks such as gRPC, DDS, or Zenoh.
• Background working with deployed hardware systems and remote device management.
• Skilled in unit testing methodologies like TDD, with familiarity with testing frameworks such as Google Test.
• An independent problem solver comfortable navigating complex, interconnected ecosystems.
• A commitment to high code craftsmanship and quality assurance.

Nice to Have:

• Experience with GUI frameworks like React or Qt.
• Prior work in the medical device or similarly regulated industries (automotive, aerospace, finance).
• Knowledge of Amazon Web Services (AWS).
• Systems engineering and design experience.
• Understanding of core security principles.

Preferred Education & Experience:

• A relevant degree (BS/MS) and significant experience in embedded, application, or cloud-based software development, ideally within regulated environments.

Other Requirements:

• Located in or near London, UK, with a hybrid work model (2 days on-site per week).
• Must be available to start ASAP.
• This role offers a 6-month contract, fully aligned with project goals and deliverables.

Ready to harness your expertise in a meaningful way? Apply now to be a key player in advancing medical technology and transforming patient care worldwide!
]]> Mon, 23 Feb 2026 00:00:00 EST 1 Regulatory Affairs Manager – In-Country Caretaker (ICC)
Client: Internal PQE hiring (no external client)
Location: Fully remote, Japan

Company Overview

An established global life sciences consulting organisation is seeking an experienced Regulatory Affairs professional to join its Japan team.

The company operates internationally across pharmaceutical and medical device sectors and supports clients with regulatory, quality, and compliance services across multiple regions. With a diverse, multinational workforce and a strong global presence, the organisation delivers both local and cross-border regulatory solutions.

Due to continued growth in Japan, the company is expanding its In-Country Caretaker (ICC) capability.

Key Responsibilities
Responsibilities include, but are not limited to:

• Optimise and manage product registration processes to ensure regulatory compliance
• Compile, review, and maintain regulatory dossiers in line with applicable guidelines
• Ensure submissions are high quality and meet regulatory authority expectations
• Plan, coordinate, and execute regulatory activities throughout the product lifecycle
• Provide regulatory advice to clients for initial submissions and lifecycle maintenance of Master Files for foreign manufacturers
• Manage registration of foreign manufacturers of active substances, including:
  • Preparation, translation, and formatting of Japanese Master Files from English DMFs
  • Submission of Master Files to Japanese authorities
  • Liaison with Marketing Authorisation Holders
  • Communication with regulatory agencies (Japanese? English)
  • Management of site accreditation activities
• Provide regulatory intelligence and updates on Japanese regulatory requirements
• Act as project manager for Japan-based regulatory projects (resource planning, budgeting, client coordination)
• Support business development activities for regulatory services in Japan

Nice to have:

• Experience supporting GMP audits
• Familiarity with EU and/or US registration processes

Candidate Requirements

• 5+ years’ experience in Regulatory Affairs within Japan
• Experience with API registration and/or In-Country Caretaker responsibilities preferred
• Strong knowledge of Japanese pharmaceutical regulations and guidance
• Previous project management experience
• Native-level Japanese and professional English proficiency

Culture & Environment
The organisation promotes a collaborative, performance-driven culture and invests in leadership development at all levels. Employees are encouraged to take ownership of projects, engage in international collaboration, and contribute to continued business growth.]]> Sat, 21 Feb 2026 00:00:00 EST 1 We’re supporting a growing orthopaedic organisation in their search for an experienced Area Sales Manager to lead commercial activities across Moldova. This is a fully field?based role, focused on driving sales, strengthening partnerships, and expanding market presence within the joint replacement portfolio.

This position requires a strong blend of sales leadership, distributor management, and hands?on engagement with hospitals, surgeons, and key decision makers.

---

Role Overview
You’ll take full responsibility for commercial performance in the assigned territory, ensuring the delivery of revenue targets, sustainable growth, and increased market share. This role combines sales execution, business management, channel development, and deep market insight, with a strong emphasis on building long?term relationships across the orthopaedic ecosystem.

---

Key Responsibilities Sales Management

• Manage all field?based orthopaedic sales activities within the territory
• Deliver revenue, growth, and market share targets in line with the business plan
• Ensure timely collection of payments and receivables
• Execute sales, marketing, and clinical initiatives on schedule

Business Management

• Build and maintain strong relationships with hospital finance teams to support efficient payment cycles
• Participate in transfer pricing discussions aligned with market dynamics and internal strategy
• Establish and maintain distributor agreements reflecting volume expectations and pricing structures
• Understand reimbursement and insurance processes within the territory
• Travel outside the territory as required for business meetings, training, or regional activities

Distributor & Channel Management

• Identify, engage, and develop a high?performing network of distributors, sub?distributors, and independent agents
• Monitor channel performance and ensure optimal product availability and service levels
• Collaborate with the country head and channel partners on forecasting, inventory management, and operational efficiency

Business Development (Existing & New Accounts)

• Meet regularly with surgeons, hospital buying committees, GPOs, and key OR/OT staff
• Deliver impactful product presentations, demonstrations, and clinical discussions
• Support negotiations and purchasing conversations with key stakeholders

Market Research & Intelligence

• Conduct detailed market mapping and collect real?time competitive insights
• Maintain structured data on competitor usage, volumes, pricing, reimbursement, and surgeon preferences
• Track current and emerging operators, OR/OT personnel, and decision?makers
• Stay informed on all tender announcements, changes, and upcoming opportunities

Compliance & Regulatory

• Ensure full compliance with company policies, country regulations, and ethical standards
• Maintain integrity in all customer interactions and commercial transactions
• Provide hospitals with required regulatory updates and documentation

---

About You

• Experience in orthopaedic or surgical device sales
• Strong commercial acumen and understanding of hospital purchasing pathways
• Proven ability to work independently within a field?based role
• Skilled in distributor management and relationship development
• Strong communication, negotiation, and market analysis abilities
• High integrity and commitment to ethical business practices

---

If you’re a driven sales professional with a passion for orthopaedics and a strong track record in territory development, we’d love to hear from you.
]]> Thu, 19 Feb 2026 00:00:00 EST 1 Position: Orthopaedic Sales Representative – Hip & Knee Implants
Location: Taiwan
Employment Type: Full-time | Field-Based
About the Role
We are seeking a motivated and experienced Orthopaedic Sales Professional to lead sales and business development efforts for hip and knee implant products across a designated APAC territory. This is a fully field-based role requiring strong engagement with hospitals, surgeons, distributors, and procurement stakeholders. The ideal candidate will have a proven background in joint reconstruction sales and a deep understanding of local market dynamics.
Responsibilities

• Drive sales performance to meet revenue targets and expand market share
• Manage receivables and ensure timely execution of sales, marketing, and clinical initiatives
• Build and maintain relationships with hospital finance and procurement departments
• Support pricing, reimbursement, and distribution strategies in alignment with company goals
• Conduct market research and maintain competitive intelligence
• Ensure full compliance with regulatory and ethical standards

Qualifications

• Minimum 2 years of recent experience in hip and knee joint reconstruction sales
• Strong knowledge of hospital procurement processes and distributor networks in APAC
• Excellent communication, negotiation, and relationship-building skills
• Willingness to travel within and beyond assigned territory as required

What’s in It for You

• Opportunity to work with cutting-edge orthopaedic technologies
• High-impact role with visibility across regional leadership
• Competitive compensation and performance-based incentives
• Professional growth through structured career development and training
• Exposure to strategic business operations and market expansion initiatives

]]> Thu, 19 Feb 2026 00:00:00 EST 1 The Opportunity:  Senior Manager of Regulatory Affairs

The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.

• Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.
• Correspond and collaborate with RevMed colleagues and departments to achieve alignment.
• Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.
• Perform regulatory research to inform business strategy. Assess and communicate risks. 
• Assure that there are no significant interruptions to the business due to regulatory compliance issues.
• Collaborates across the organization at all levels, across functional groups, and with executive management.
• Develop regulatory strategies to inform associated budgets, tools and specialized support. necessary for efficient operations.
• Establish collaborative and effective relationships with colleagues in Clinical, Clinical Operations and Clinical Research Organizations to ensure cross-functional alignment and team effectiveness.

Required Skills, Experience and Education:

• Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience.
• Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
• Proven track record of successful submissions within a regulatory environment.
• Exceptionally strong team player with excellent interpersonal and communication skills.
• Detail-oriented with strong organizational skills and high-quality standards.

Preferred Skills:

• Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations and guidance preferred.
• Direct experience with IND/NDA filings.

]]> Wed, 18 Feb 2026 00:00:00 EST 0 Role: Electrical Engineer (Senior level)
Location: Japan

Overview
An established pharmaceutical manufacturing organisation is seeking an experienced Electrical Engineer to support operations within a sterile manufacturing environment.

This role will focus on the design, maintenance, and optimisation of electrical systems across manufacturing areas, ensuring reliability, compliance, and operational continuity.

Key Responsibilities

• 
  Design, implement, and maintain electrical systems within the manufacturing facility
  
• 
  Provide technical expertise related to Class C cleanroom environments, HVAC systems, and filling line equipment
  
• 
  Troubleshoot and resolve electrical issues to ensure continuous and safe operation
  
• 
  Collaborate with cross-functional teams including production, quality, engineering, and maintenance
  
• 
  Ensure electrical systems comply with industry regulations and internal standards
  
• 
  Oversee maintenance and operational performance of cleanroom-related equipment
  
• 
  Conduct regular inspections and technical assessments to identify risks and improvement areas
  
• 
  Monitor and support environmental control systems, including particle monitoring within sterile areas
  
• 
  Maintain documentation and drawings related to electrical systems
  
• 
  Stay informed on industry developments and advancements relevant to sterile manufacturing environments
  

Candidate Requirements

• 
  7–10 years of hands-on electrical engineering experience within pharmaceutical manufacturing
  
• 
  Direct experience supporting sterile manufacturing environments
  
• 
  Strong understanding of regulatory and compliance requirements for pharmaceutical facilities
  
• 
  Experience working with Class C cleanroom environments and HVAC systems
  
• 
  Ability to troubleshoot and optimise electrical systems in operational facilities
  

]]> Tue, 17 Feb 2026 00:00:00 EST 1 Summary
We are seeking a Electrical & Instrumentation Engineer to play a critical role in delivering reliable, compliant, and innovative solutions for complex capital projects. This position offers the opportunity to work across all phases of projects from planning and design to procurement, construction, and start-up while collaborating with multidisciplinary teams to make a global impact.
Primary Responsibilities
In this role, you will:

• Lead Project Scope: Manage assigned scope, cost, and schedule for all responsibilities.
• Design and Develop: Create low-voltage power distribution systems and motor control designs.
• Instrumentation Expertise: Select and size instrumentation based on P&IDs and site standards.
• Control Systems: Choose control system hardware aligned with site requirements.
• Technical Documentation: Prepare equipment specifications, bid packages, and detailed schematics including single lines, motor control diagrams, and loop sheets.
• Vendor and Contractor Oversight: Perform vendor evaluations, monitor progress, attend factory acceptance testing, and supervise contractors during construction to ensure safety, quality, and schedule adherence.
• Commissioning and Turnover: Execute equipment start-up, develop commissioning protocols, and prepare turnover packages.
• Compliance and Standards: Size electrical components per NFPA 70 and adhere to Good Manufacturing Practices (GxP), including compliance, change control, quality oversight, and validation.
• Collaboration: Coordinate with other disciplines throughout design, construction, and start-up phases.
• Configuration: Provide initial settings for VFDs and motor starters.
• Communication and Problem-Solving: Deliver clear verbal and written communication, demonstrate strong problem-solving skills, and foster a collaborative team environment.

Education and Experience Requirements Based on Level
Staff Engineer Level:
Minimum Education: Bachelor's Degree in Engineering or related field.
Professional registration and/or certifications as appropriate.
Minimum of 5 years of related experience. Experience in Biotech, Pharmaceutical, or Chemical Industry preferred.

 

Principal Engineer Level:
Minimum Education: Bachelor’s Degree in Engineering or related field.
Professional registration and/or certifications as appropriate.
Minimum of 8 years of experience. Experience in Biotech, Pharmaceutical, or Chemical Industry preferred.
Additional Requirements
PE license in NC preferred.
Occasional international travel required (e.g., Spain, Canada).

 

Occupational Demands:

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.

 
]]> Mon, 16 Feb 2026 00:00:00 EST 1 Join Our Team as a Senior Test Engineer (Devices) – Drive Innovation, Ensure Safety, Elevate Quality

Are you a passionate, highly technical Software Development Engineer in Test (SDET) with a knack for automation and a desire to make a meaningful impact in medical device technology? We are seeking a dedicated Senior Test Engineer to lead automation efforts for cutting-edge device platforms, ensuring the highest standards of reliability and safety. This is a fantastic opportunity to be at the forefront of innovation within a dynamic environment, collaborating with talented teams to shape the future of healthcare technology.

What You’ll Bring to the Role:

• Expertise in designing, developing, and maintaining scalable automated test frameworks for embedded and connected devices (Android, Linux, IoT).
• Strong proficiency in test automation programming languages such as Python, Java, or equivalent.
• Hands-on experience with manual test management tools and automation frameworks like Selenium, Appium, or Espresso.
• Familiarity with CI/CD pipelines using Jenkins, GitHub Actions, Azure DevOps.
• Deep understanding of device operating systems, APIs (REST, IPC), WebUI, OTA updates, and service-oriented architecture.
• Knowledge of medical device software standards such as IEC 62304 is a plus.
• Proven ability to work autonomously, lead initiatives, and collaborate effectively across teams.

Nice to Have Skills:

• Experience with medical device software development, video protocol testing, and performance engineering.
• Working knowledge of regulatory standards and compliance.
• Experience with web-based interfaces, IoT device management, and OTA deployment strategies.

Preferred Education and Experience:

• Bachelor’s degree in Computer Science, Engineering, or related field.
• Minimum 3 years of hands-on experience in test automation, software development, or SDET roles, or an advanced degree with 2+ years relevant experience.
• Demonstrated success in implementing automated solutions and leading testing initiatives.

Other Requirements:

• Must be able to commute to our London-based office at least 3 days/week, with a preference for fully on-site presence.
• This is a 6-month contract position.
• Availability to start ASAP.

Be part of a forward-thinking team that values innovation, quality, and your professional growth. If you’re ready to make a real difference in healthcare technology and meet the qualifications outlined, we encourage you to apply now and take the next step in your career!
]]> Thu, 12 Feb 2026 00:00:00 EST 1 A rapidly expanding structural heart business is building its footprint in Australia and is hiring a (Junior) Area Sales Manager to drive growth across NSW. This role is perfect for someone with proven TAVI experience who wants real ownership, big impact, and the chance to build a territory from day one.
The Role
You’ll be the on?the?ground force behind the NSW strategy — developing relationships, supporting procedures, and opening new doors across major cardiac centres. Expect a mix of case support, education, and high?energy commercial activity as you build the customer base across Sydney and wider NSW.
What You’ll Be Doing

• Growing the TAVI portfolio across NSW through focused, hands?on territory management.
• Partnering with interventional cardiology and cardiac surgery teams to support cases and provide deep product expertise.
• Building new accounts, driving adoption, and creating awareness in a competitive market.
• Developing territory plans, identifying gaps, and executing smart strategies to win market share.
• Acting as a clinical and commercial ambassador for a fast?moving, innovation?driven organisation.

What You Bring

• 2+ years recent TAVI sales experience — essential.
• Experience with major TAVI systems or distributors in this therapy area.
• No more than 10 years total experience — suited to someone ambitious, adaptable, and still in a growth phase.
• Entrepreneurial mindset: comfortable with building a market, prospecting, and taking initiative.
• Confident in clinical environments with strong relationship?building skills.
• Based in Sydney and able to cover broader NSW when required.

Why This Role

• Lead the growth of a high?potential territory.
• Autonomy to shape your approach and make visible impact.
• Strong package and long?term pathway within a premium therapy area.

If you want ownership, development, and the chance to grow a TAVI business in a major territory, this role gives you the platform to do it.
]]> Mon, 09 Feb 2026 00:00:00 EST 1 We’re partnering with a fast?growing structural heart organisation to recruit a (Junior) Area Sales Manager to build and expand their presence across Victoria. This is a high?visibility role for someone hungry to make an impact in the TAVI market, with full ownership of driving adoption and shaping commercial strategy from the ground up.
What you’ll do

• Take responsibility for territory growth, developing a strong pipeline and driving adoption of a best?in?class TAVI portfolio.
• Build long?term relationships with interventional cardiologists, cardiac surgeons, cath lab teams, and hospital procurement.
• Deliver case support, product training, and clinical expertise to ensure exceptional outcomes and customer confidence.
• Open new accounts, identify untapped opportunities, and execute strategies to accelerate market penetration.
• Act as the face of the business across Victoria, championing product excellence and supporting clinical education initiatives.

What we’re looking for

• Recent experience (2+ years) selling TAVI products.
• Background with major TAVI manufacturers or their distributors.
• Up to 10 years total experience — suited to someone earlier in their career who is ambitious, adaptable, and eager to grow.
• Entrepreneurial mindset with the resilience to build a market from scratch: proactive, strategic, and willing to knock on doors.
• Strong relationship-builder with credibility in clinical environments and a track record of influencing key stakeholders.
• Based in Melbourne with flexibility to travel across the state.

What’s on offer

• Opportunity to spearhead growth for an innovative structural heart business.
• Autonomy, visibility, and scope to shape the territory your way.
• Competitive package and long-term career development within a premium therapy area.

If you thrive in high-growth environments and want to make your mark in TAVI, this is a rare opportunity to take ownership and build something meaningful.
]]> Mon, 09 Feb 2026 00:00:00 EST 1

We’re supporting a rapidly growing organisation within the cardiovascular space as they expand their portfolio with a new Surgical Heart product line. To strengthen their presence in the UK, they are looking for an Area Sales Manager with strong experience in surgical heart valves to support product adoption across the North West.
Role Overview
This is a high?visibility commercial role focused on driving regional growth for a newly introduced surgical heart therapy. You will work closely with cardiac surgeons, theatre teams, and multidisciplinary stakeholders to support case activity, build relationships, and elevate product utilisation across key cardiac centres.

You will join an established UK commercial organisation—already active in TAVI and Coronary therapy—with a dedicated specialist team now being built specifically for the Surgical Heart portfolio.
Key Responsibilities

• Develop and execute regional sales strategies to grow adoption of the Surgical Heart product line
• Build and maintain strong relationships with cardiac surgeons, clinical staff, and hospital leadership teams
• Support case coverage, product demonstrations, education, and training activities
• Identify new business opportunities across the region and develop long?term account plans
• Collaborate closely with national sales leadership and cross?functional clinical teams
• Provide ongoing market insights to support strategic planning and product positioning

About You

• First commercial experience  within medical devices
• Essential: direct experience selling Surgical Heart technologies
• Background working for a major cardiovascular device manufacturer
• Comfortable working in clinical environments and supporting theatre?based activity
• Strong stakeholder management skills and a consultative, relationship?driven approach
• Motivated by new product introduction and early?stage market development

What’s on Offer

• A chance to be part of a new specialist team within a well?established cardiovascular organisation
• Opportunity to drive adoption of a new surgical heart therapy already entering the UK market
• Strong collaboration with existing national teams in TAVI and Coronary therapy areas
• High level of autonomy with strong internal support

If you’re a driven sales professional with proven experience in Surgical Heart products and looking to take ownership of a growing region, we’d love to hear from you.
]]> Fri, 06 Feb 2026 00:00:00 EST 1 Principal HR Generalist

Elevate your HR career to new heights with our dynamic Principal HR Generalist role, a pivotal position that combines strategic influence with hands-on expertise. In this leadership-driven role, you'll partner closely with business leaders to shape an exceptional employee experience, foster organizational growth, and drive HR initiatives that make a real impact. Join us in crafting a thriving workplace culture grounded in innovation, compliance, and excellence.

Required Skills

• Proven experience as an HR Generalist or similar role, with the ability to handle multiple HR functions effectively.
• Strong knowledge of employment laws, HR policies, and best practices.
• Exceptional interpersonal and communication skills to build trusted relationships at all levels.
• Expertise in organizational development, change management, and employee engagement strategies.
• Data-driven mindset with the ability to analyze HR metrics and translate insights into actionable plans.
• Ability to coach and advise managers and leaders on a wide range of employee lifecycle matters.
• Proficiency in HRIS systems and general proficiency with MS Office.

Nice to Have Skills

• Experience working in a regulated industry or within a global organization.
• Certifications such as SHRM-SCP, SPHR, or similar HR credentials.
• Knowledge of talent acquisition strategies and employer branding.
• Exposure to internal equity and compensation planning.
• Change management certification or experience leading large-scale transformations.

Preferred Education and Experience

• Bachelor’s degree in Human Resources, Business Administration, or a related field; Master’s degree preferred.
• A minimum of 8+ years of HR experience, with at least 3 years in a senior or strategic HR role.
• Demonstrated success in leading HR initiatives within fast-paced, complex environments.

Other Requirements

• Willingness to collaborate across multiple regions and functions.
• Strong organizational skills and attention to detail.
• A proactive, strategic mindset with a passion for enhancing organizational effectiveness.

This is an exciting opportunity to influence HR strategy at a high level—if you’re ready to make a meaningful impact and take your HR expertise to the next stage, we encourage you to apply now and join a forward-thinking team committed to excellence.
]]> Fri, 06 Feb 2026 00:00:00 EST 1 Can you please confirm your top 3 skills sets required?  General quality experience in med device preferred; Design Assurance/Design Quality; self-driven, independent ability to engage with cross functional teams and manage project workload; Lean/six sigma project improvement experience

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Be the quality lead representative on global quality improvement, cost-down, and efficiency projects; engage in, review, and approve qualification deliverables, protocols, and processes; ensure products and quality processes maintain regulatory compliance while achieving cost down and efficiency targets

What products (if any) will this role support?  Quality team member for Global quality (GOSC) efficiency projects across multiple products

What is your target years of experience?  5-7 yrs depending on education and experience

 

___________________________________________________________________________________________________
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Fri, 23 Jan 2026 00:00:00 EST 1  

Associate Director, Global Submission Management

The Associate Director of Global Submission Management (GSM) is responsible for leading, managing, strategizing, and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This role involves providing hands-on operational support for submission activities while ensuring strategic alignment and process optimization across different regions. It also includes resource planning, budgeting, vendor management, and technical oversight to support the objectives of Global Regulatory Operations. The Associate Director will collaborate with the Heads of Submissions Management for the EU and Japan as needed and utilize “Follow-the-sun” processes to ensure submission timelines are met regardless of the region.

The Associate Director, Global Submission Management (GSM, is responsible for the effective operation of Global Submission projects, ensuring the consistent application of global procedures and standards, and proactively assessing process performance for necessary optimizations.  The Associate Director serves as the primary liaison between R&D functions, acting as the submission lead for designated global applications (e.g., INDs, NDAs, MAAs, supplements, amendments, and variations), to facilitate cross-functional logistics and communication that support submission planning. This role provides submission leadership by managing the operational aspects of global regulatory submissions to produce high-quality, time-sensitive deliverables in accordance with agreed-upon submission timelines.  Additionally, the AD oversees the process for creating and updating the Global Regulatory Operations Submission Content Plan (GSCP) for major regulatory submission final deliverables, ensuring compliance with applicable regulatory agency regulations, guidelines, and specifications (e.g., FDA, EMA, HC, PMDA, Emerging Markets, ICH, CDISC) within defined timelines.

 

Essential Functions:

 

Leadership and Strategy

• Provides leadership for the Global Submissions Team ensuring projects are appropriately resourced, partnering with other regional Submission Heads for additional support for resources when needed. 
• Provides the Regulatory Submission Management for a lead compound or submission project that has been identified as critical to business success.
• Provides management oversight for the Global Submission Management department, supporting the generation, and when necessary, the re-engineering of “Best Practices” related to global submission management and dossier development in pursuit of optimal processing performance while maintaining full compliance with Health Authority requirements and guideline.

 

Global Collaboration

• Collaborates with the EU and Japan Heads of Submission Management to optimize resource allocation and implement “follow-the-sun” workflows for timely submissions across all regions.
• Foster strong cross-regional communication and collaboration to support global objectives.
• Promotes a culture of performance and teamwork, with a focus on staff development in technical skills, interpersonal skills, education, and training, enhancing competency and professionalism.
• Maintains visibility within the organization by regularly presenting on various GSM-related topics. This includes showcasing the achievements, ongoing projects, and developments of the GSM organization, as well as emerging trends in eCTD regulatory submissions. Additionally, cultivate positive and constructive relationships with other members of the Global Regulatory Operations (GRO) team and regulatory colleagues.
• Actively participates in agency/industry events regularly, staying abreast of current developments, trends, and technologies, fostering constructive business relations with other industry peers, Health Authority representatives, and critical business partners/vendors.
• Analyzes trends and evaluates the impact of changes in Health Authority requirements for e-submissions, communicating these changes to the relevant areas within and driving the necessary changes to processes and procedures.
• Ensure the timely completion of all administrative tasks for this position, including but not limited to monthly reports, performance objective setting, performance reviews, and training, for self and staff.

 

Hands-On Submission Support

• Actively participates in submission planning and execution, including document compilation, publishing, and quality checks.
• Provide technical oversight and troubleshooting for eCTD submissions and related systems.

 

Operational Excellence

• Ensure consistent application of GSM global procedures and standards.
• Proactively monitors and assess process performance, identifying opportunities for continuous improvement.

 

 

Requirements

• Bachelor’s degree in scientific or information technology field; advanced degree preferred
• 8+ years of pharmaceutical industry regulatory experience
• 5+ years of experience with submissions management, process development, standards development and compilation of electronic major submissions required
• Proficient with U.S. and EU submission requirements including but not limited to Emerging Markets
• Advance experience with the drug development process and eCTD regulatory submission standards
• Expert understanding of Project Management concepts and techniques
• Ability to apply SOPs regulations pertaining to electronic submissions
• Ability to lead cross-functional team, establish effective relationships with team members and work well in a cross functional team environment
• Advance experience creating timelines for the development and submission of drug filings to regulatory health authorities
• Excellent organizational skills to support multi-task and manage submission timelines in a fast-paced environment with changing priorities
• Well-organized with the ability to multi-task and work with minimal supervision
• Ability to manage change to support organization’s effectiveness by implementing change
• Effectively communicates written and verbal communication skills
• Demonstrates strong analytical, problem solving and critical thinking skills with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution.
• Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)

 

Technical Skills Required

• Advance working knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practices
• Proficiency in eCTD publishing tools (e.g., Lorenz docuBridge, Extedo eCTDmanager, or equivalent).
•  Strong understanding of ICH guidelines, regional regulatory requirements, and data standards (e.g., CDISC).
• Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (e.g., Veeva Vault, SharePoint, Documentum)
• PowerPoint, SharePoint, XML, Adobe Acrobat, ISI Toolbox and eData transfer systems
• Ability to troubleshoot technical issues related to electronic submissions and publishing.

]]> Tue, 20 Jan 2026 00:00:00 EST 0 A well?established med?tech company with a growing presence across Australia is expanding into the orthopaedic reconstruction field and is seeking a Territory Manager to lead commercial activities across the Canberra region. The organisation already operates locally with a strong team in a different therapy area, and this new position will support the rollout of a dedicated Hip & Knee implant portfolio.

This is a key role for someone who knows the orthopaedic theatre environment inside out and is excited to build momentum for a new product line within an already trusted brand.

---

About the Role
You’ll take ownership of commercial activity for Hip & Knee reconstruction solutions within the ACT region and surrounding territories. This is a fully field?based role where you’ll work closely with surgeons, hospitals, procurement teams and channel partners to establish awareness, drive adoption and support high?quality clinical use.

Although you’ll be responsible for leading the growth of this specific area, you’ll benefit from the structure and support of an existing local team and a national organisation that is already well integrated within Australia’s healthcare environment.

---

Key Responsibilities Sales & Territory Leadership

• Lead commercial activity for Hip & Knee reconstruction solutions across Canberra.
• Build strong relationships with surgeons, operating theatres and hospital stakeholders.
• Support clinical cases, education sessions and product evaluations.
• Drive revenue growth in line with the strategic plan.
• Ensure smooth execution of all sales and clinical activities across the territory.

Business Operations

• Maintain strong communication with hospital finance departments to support payment cycles.
• Work with national leadership on pricing discussions, market positioning and commercial decisions.
• Understand local procurement systems, reimbursement structures and market access pathways.

Distributor & Channel Partner Management

• Identify and develop distributor or agent partnerships when needed to support market coverage.
• Collaborate with partners on training, planning and operational coordination.
• Monitor stock levels and work with local teams to ensure timely product supply.

Hospital & Surgeon Engagement

• Present clinical insights, demonstration tools and educational material to decision?makers.
• Participate in value discussions, long?term planning and partnership development.
• Engage regularly with procurement groups and hospital buying committees.

Market Insight & Data Tracking

• Conduct ongoing mapping of the surgeon landscape, hospital activity and competitive dynamics.
• Maintain detailed information on procedural volumes, price movements and decision?making channels.
• Track upcoming tenders and changes in procurement frameworks.

Compliance & Professional Standards

• Uphold organisational values in all commercial interactions.
• Ensure all promotional and clinical engagement activities align with local regulations and internal policies.
• Provide required updates and documentation to hospital partners as needed.

---

  Ideal Candidate

• Minimum of three years' experience in Hip & Knee implant sales.
• Recent experience in orthopaedic reconstruction settings.
• Strong clinical understanding and confidence in the operating theatre.
• Self?driven, commercially minded and comfortable managing a territory independently.
• Experience with distributor/channel management is highly valued.
• Excellent relationship?building skills with both clinical and commercial stakeholders.

]]> Fri, 09 Jan 2026 00:00:00 EST 1 A global medical technology organisation is entering the orthopaedic market in Australia & New Zealand and is seeking an experienced commercial professional to lead its launch in New Zealand. With no existing local team, this is an opportunity to build the business from the ground up and act as the company’s primary representative in the country.

The role is based in Christchurch, with flexibility and significant autonomy. Due to the absence of a legal entity in New Zealand, the position will operate through an independent contractor model or Employer of Record arrangement.

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The Opportunity
This is a hands?on, field?based role covering orthopaedic reconstruction with a strong focus on Hip and Knee implants. You will take responsibility for sales execution, distributor management, business development, and market intelligence while establishing a sustainable long?term commercial presence.

Support and resources will be provided by regional leadership, but day?to?day commercial ownership will sit fully with you. This is an ideal opportunity for someone motivated by growth, autonomy, and building a business from zero.

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Key Responsibilities Sales & Territory Management

• Drive commercial activity for Hip and Knee reconstruction solutions across the assigned region.
• Manage day?to?day field sales, case support and surgeon engagement activities.
• Achieve business growth and revenue goals aligned with the annual plan.
• Ensure timely coordination of orders, product availability, and customer needs.
• Oversee field?based clinical and marketing initiatives to support surgeon adoption.

Business Operations

• Build strong commercial relationships with hospital finance departments to support payment processes.
• Collaborate with regional leadership on pricing strategies and market positioning.
• Establish distribution agreements with appropriate volume expectations and commercial terms.
• Develop understanding of regional reimbursement and insurance pathways.
• Travel outside your territory as required for business and training purposes.

Distributor & Channel Development

• Identify, engage, and manage distributors, sub?distributors and independent agents.
• Support partners with product knowledge, planning, and operational execution.
• Maintain visibility over stock levels and ensure reliable, timely supply through the distribution network.

Hospital & Surgeon Engagement

• Meet regularly with surgeons, procurement teams, and operating theatre staff to introduce solutions, demonstrate technology, and support purchase discussions.
• Present clinical data, training materials, and product insights to key decision?makers.
• Participate in value discussions, product evaluations and long?term partnership planning.

Market Insight & Intelligence

• Conduct ongoing market mapping and gather real?time insights on competitors, pricing trends, usage data and growth opportunities.
• Maintain structured records of surgeon profiles, hospital dynamics, procedural volumes and purchasing behaviours.
• Monitor updates on tenders, upcoming bids and changes in procurement models.

Compliance & Governance

• Uphold high ethical standards in all business interactions.
• Ensure local execution of activities aligns with company policies and country regulations.
• Provide periodic product updates to hospitals in line with regulatory expectations.

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Who They’re Looking For

• Minimum of three years’ experience in Hip and Knee reconstruction sales (specifically implants).
• Recent, up?to?date involvement in the orthopaedic theatre environment.
• Strong commercial instincts with the ability to operate independently.
• Experience building a territory, developing distribution channels, and growing surgeon relationships.
• Highly organised, adaptable, and comfortable with a start?up?style environment.

]]> Fri, 09 Jan 2026 00:00:00 EST 1 Finance Business Project Manager
Position Summary:
The Finance Business Project Manager will lead initiatives to implement IT systems supporting financial operations, reporting, and compliance. This role ensures financial requirements are translated into effective technical solutions.

Key Responsibilities:

• Collaborate with IT and finance teams to deliver systems for budgeting, forecasting, and reporting.
• Ensure compliance with financial regulations and internal controls.
• Lead project launches, testing, and readiness activities.
• Develop financial charters, integrated plans, and training programs.
• Act as the liaison for finance stakeholders, resolving issues and managing risks.
• Support governance and decision-making processes.
• Manage multiple finance-related projects in a dynamic environment.

Qualifications:

• Experience in finance, accounting, or financial systems.
• Strong analytical and communication skills.
• Familiarity with ERP systems (e.g., Oracle, SAP).
• PMP or financial certifications preferred.

]]> Thu, 27 Nov 2025 00:00:00 EST 1 Job Title: Quality Manager
Hours: M-F 8-5 or as needed

Job duties:

• Oversee the lab and the lab personnel. 
• Proficient with wet chemistry including pH, manual titrations, autotitrators including KF. Also, must know ICP 
• Responsible for internal and external audits
• SQF Practitioner
• Understand ISO9001
• Collaborate with different departments including production department.  

]]> Tue, 04 Nov 2025 00:00:00 EST 0 Shape the Future of Structural Heart Therapy in APAC
We’re seeking a dynamic and driven sales professional with recent experience in transcatheter aortic valve implantation (TAVI) to lead market development in a fast-growing territory. This is a rare opportunity to build something from the ground up—bringing world-class cardiovascular solutions to new hospitals, forging strong clinical relationships, and driving adoption in a competitive space.

What You’ll Do

• Identify and engage key hospitals, physicians, and decision-makers in structural heart care
• Present the clinical and economic value of our TAVI portfolio to interventional cardiologists and cardiac surgeons
• Support procedures and collaborate with clinical teams to ensure confidence in product performance
• Develop territory-specific strategies to grow market share and build long-term partnerships
• Monitor market trends and provide insights to shape commercial direction

Who You Are

• 2+ years of recent experience selling TAVI products
• Background with leading cardiovascular companies or their distributors
• Comfortable with market-building, strategic thinking, and clinical engagement
• Fluent in local language and English; open to travel across the region

]]> Fri, 31 Oct 2025 00:00:00 EDT 1 Location: Field-Based | Romania

Type: Full-Time

Build the Market. Shape the Future.
We’re looking for a bold, entrepreneurial sales professional with recent experience in transcatheter aortic valve implantation (TAVI) to lead market development in a new territory. This is a ground-floor opportunity—no legacy accounts, no hand-holding. You’ll be responsible for opening doors, crafting sales strategies, and driving adoption of our cutting-edge TAVI solutions.

What You’ll Be Doing

• Identify and engage hospitals, physicians, and decision-makers in structural heart therapy
• Deliver compelling product presentations and clinical insights to interventional cardiologists and cardiac surgeons
• Support procedures and collaborate with clinical teams to ensure confidence in product performance
• Develop territory-specific strategies to grow market share and build long-term partnerships
• Track competitive activity and provide feedback to shape commercial direction

Who We’re Looking For

• 2+ years of recent experience selling TAVI products
• Background with leading cardiovascular companies or their distributors
• Comfortable with cold starts, strategic thinking, and high-touch selling
• Fluent in local language and English; willing to travel extensively

What You’ll Gain

• Strategic ownership of a new territory
• Strong support from global and regional teams
• Competitive compensation and performance incentives

A fast-paced, purpose-driven environment]]> Fri, 31 Oct 2025 00:00:00 EDT 1
Candidate Profile:

• 10+ years of relevant experience in an administrative or executive support role
• Experience in the biotech/pharmaceutical industry preferred
• Strong organizational and multitasking skills
• IT-savy, with the ability to work with systems like SAP

Contract Details:

• On-site presence required 2–3 days per week in Princeton, NJ
• Start date: ASAP
• Duration: 6-month contract

 

We are looking for a highly organized and proactive Management Assistant to support the Head of Global Product Quality and other executive leader in managing day-to-day activities and ensuring the efficient operation of our US activities. The ideal candidate will have exceptional administrative skills, excellent communication abilities, and the ability to thrive in a fast-paced and dynamic environment within the biotech industry.

Your mission

• Provide administrative support to the Head of Global Quality and other executive, including calendar management, scheduling meetings, and coordinating travel arrangements, and expenses management.
• Prepare and distribute presentations, and reports on behalf of management for various audiences.
• Assist in the organization and coordination of internal and external meetings and business trips.
• Act as a liaison between management and internal/external stakeholders, handling inquiries and requests in a professional and timely manner.
• Maintain accurate and up-to-date electronic and physical filing systems, ensuring accessibility and confidentiality of documents.
• Assist in the preparation and distribution of materials for board meetings, team meetings, and other strategic sessions.
• Support conducting of research and compilation of data for management to conduct decision-making and strategic initiatives
• Coordinate special projects and initiatives as assigned by management, ensuring timely completion and adherence to deadlines.
• Uphold confidentiality and discretion in handling sensitive information and communications.

Job requirements

• Bachelor's degree in Business Administration, Life Sciences, or related field preferred with 10+ years of relevant experience.
• Proven experience in an administrative or executive support role, preferably within the biotechnology or pharmaceutical industry.
• Strong proficiency with digital tools such as: Word, Excel, PowerPoint, Outlook and other relevant software applications, including business applications such as SAP, Concur and SuccessFactors
• Excellent organizational skills with the ability to prioritize tasks effectively and meet deadlines in a dynamic environment.
• Exceptional communication skills, both written and verbal, with a high level of professionalism and attention to detail.
• Ability to work independently with minimal supervision and as part of a collaborative team.
• Strong interpersonal skills with the ability to build relationships and interact effectively with individuals at all levels of the organization.

]]> Wed, 08 Oct 2025 00:00:00 EDT 0