https://CAREERS.PLANET-PHARMA.COM/ en-us
This is what you will do:
This company is seeking an Associate Scientist III to join the Viral Vector Production group in Durham, NC. This role supports both upstream and downstream operations with a particular focus on sample coordination, harvest train activities, and data recording/analysis to enable reliable production of AAV vectors. Candidates with direct, hands-on AAV production experience will be prioritized.

You will be responsible for:
• Upstream support: Assist with cell expansion, transfection, and bioreactor (Ambr250 to 50L stir tank) operations, routine in-process sampling, and monitoring of process parameters.
• Downstream support: Participate in clarification, chromatography, and TFF/filtration steps; assemble/disassemble and clean harvest train components; and stage materials.
• Sample management: Coordinate sample plans across unit operations; label samples accurately and per SOPs; maintain chain-of-custody and timely delivery to QC/analytics.
• Equipment operations: Perform setup, operation, and teardown of harvest trains, pumps, filters, tubing sets, single-use systems, and ancillary equipment; support/perform pre-use checks and readiness.
• Data capture and analysis: Accurately record process data, batch records, and logbooks; compile and analyze data for trends, yields, and process performance; contribute to run summaries and troubleshooting.
• Compliance and quality: Follow SOPs and cGMP/cGLP principles as applicable; support investigations, maintain clean, safe work areas and proper documentation.
• Cross-functional collaboration: Work closely with Manufacturing, Process Development, QC/Analytics, Supply Chain, and Facilities to ensure schedule adherence and issue resolution.
• Continuous improvement: Identify and implement improvements in sampling workflows, equipment readiness, and documentation practices.

You will need to have:
Qualifications / Training & Education
• BS in Biochemistry, Bioengineering, Chemical Engineering, Molecular Biology, or related field with 4+yrs of relevant experience or MS with 2+ yrs experience in viral vector or biopharmaceutical production or process development.

Knowledge & Experience
• Strong track record of building successful relationships with supervisors, peers, suppliers, customers, partners and stakeholders
• Excellent communication skills and ability to work well with multiple individuals.
• Ability to work on several projects simultaneously and to switch focus as needed
• Ability to keep accurate and organized records
Technical Competencies
• Familiarity with AAV production including transient transfection, suspension platforms and core downstream unit operations
• Experience with single-use bioreactors (Ambr, Wave and 50L Stir Tank), TFF, depth filtration and affinity/ion exchange chromatography
• Knowledge of in-process analytics relevant to AAV (e.g., titer by qPCR/dPCR/ddPCR, capsid protein assays, residual DNA, endotoxin, %Empty/Full assays)
• General molecular/microbiology skills
• Experience in aseptic technique
• Track record of prioritizing multiple, complex, high priority tasks and ensuring timely delivery to meet project needs
• A strong attention to detail
• Working knowledge of Microsoft Office products, especially with Microsoft Excel
• Effective communication, collaboration, and problem-solving skills in cross-functional settings.
• The duties of this role are generally conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift 15 pounds unassisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Strong Preference to Candidates with:
• Direct experience with AAV production (upstream and downsteam) at lab or pilot scale
• Experience with analytical assays related to AAV
• Hands on experience with upstream bioreactors including Ambr250, Wave, and 50L stir tanks]]> Fri, 06 Mar 2026 00:00:00 EST 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, 06 Mar 2026 00:00:00 EST 1
Job Description:

The position of Quality Specialist is responsible for providing support for R&D Quality activities that support the company’s Quality Management Systems (QMS). This position is responsible for providing support to all functional areas within R&D including completion of quality activities (e.g. training, vendor qualification, audit support). Activities include but are not limited to procedural document management, vendor qualification, audit/inspection support, and training compliance activities to assure QMS alignment and compliance. This position works with minimal supervision, requires a very high degree of interaction with other company employees and resolves more complex issues requiring evaluation of identifiable factors. Standard operating procedures provide guidance in performing the activities required.


Requires 2-3 years of Quality Assurance or Quality Control experience.
Requirements (education, skills, experience, etc.): Bachelors Degree Minimum



Pay Rate Range: $20-25/hr depending on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1 Roles and Responsibilities

• Calendar scheduling including agenda preparation for internal and external meetings
• Proactively manage calendars across multiple international time zones with quick responsivity and flexibility for dynamic changes
• Responsible for arranging travel, making reservations, and keeping details organized
• Manage expense reporting (via Expensify) for multiple executives, and work with Accounting team to ensure compliance with corporate policies or guidance
• Provide high-quality support while anticipating needs
• Serves as the initial, highly professional interface with key external contacts such as customers and vendors and shows effective written and verbal communication with external as well as all internal contacts including management, staff, and contractors
• Develops and demonstrates working knowledge of systems and serves as a “go to” person for frequently asked questions
• Coordinate meetings and other corporate events
• Organize and order company and business lunches as part of in person meetings
• Perform intermediate to advanced desktop publishing including word processing, spreadsheets, and presentations
• Draft, review, and/or edit written material to ensure accuracy, neatness, correct punctuation, and grammar; recommend changes to improve readability and clarity

• Transcribe information of a technical, confidential, and/or sensitive nature
• Assist with organization of presentations and related collateral materials as needed
• Perform other related duties as requested

Qualifications and Experience

• Associates or Bachelor’s degree in Business or the equivalent knowledge and experience required
• Excellent organizational, communication and analytical skills with meticulous attention to detail with a proven track record of serious commitment to accuracy and quality while meeting goals or deadlines
• Demonstrated exceptional work ethic, professional, friendly, supportive image, and a “can-do” attitude
• 3+ years of related executive assistant experience preferred with demonstrated growth required in a start-up environment; some experience in biotech/life science industry required
• Must demonstrate intermediate to advanced computer skills and software application proficiency in Microsoft Word, Excel, PowerPoint and Outlook. PowerPoint experience preferred
• Adept at administering online, cloud-based applications (for example, Zoom, DocuSign and Expensify), experience with AI tools a plus
• Familiarity with Cloud based sharing and storage (i.e. Box and SharePoint)
• Team player and self-starter with the ability to work collaboratively across the business and with all levels of the organization and independently on multiple projects concurrently in a fast-paced environment with strong time management and organizational skills to meet deadlines, and respond quickly and efficiently
• Confident, intelligent, and dedicated individual who is focused on making improvements and reaching out for new solutions and fostering strong relationships with colleagues
• The candidate must be highly motivated and proactive; able to work independently with minimal supervision; respond to changing priorities and short lead times for multiple tasks; willingness to acquire new skills; and be able to identify problems and work toward solutions

Comp target $100-130K based on experience]]> Fri, 06 Mar 2026 00:00:00 EST 0 *Depending on experience

Description:
In this role, you will play a vital role in supporting our team of seasoned scientists and engineers, contributing to lab-based projects that drive innovation and excellence. Our team is responsible for progressing the dermal filler product portfolio by designing and developing cutting edge products in our pipeline and optimizing existing commercial products, ensuring they meet both company and industry standards. You will have the opportunity to contribute to product development and innovation work in a large, global organization, participating in meaningful projects that have a tangible impact on our business and the broader market.]]> Fri, 06 Mar 2026 00:00:00 EST 1 Department: Bioanalytical Sciences (BAS)
Job Title: Sr. Administrative Business Partner
Description:
We are seeking a dynamic and professional individual that can work in a fast-paced environment providing administrative support. The Administrative Business Partner will provide direct support to Directors in BAS groups, including BioAnalytical Sciences Operations, Bioassay, Immunoassay, and Mass Spec. In addition, this individual will provide general administrative support to members of the BAS team and execute on project coordination activities to support day-to-day business portfolio operations.
This position will report into the BAS Business Manager. He/She will collaborate with other administrative business partners, within the department, by providing coverage and work load balance. This individual, when requested by his/her manager, may also collaborate with the other administrative professionals within Development Sciences, and participate in other projects as needed.
The administrative professional must exercise sound business judgment and discretion with sensitive, confidential and proprietary information. This individual is expected to work independently while being a strong team player by being proactive, creative, self-directed, and detail-oriented when managing multiple priorities and complex projects.
Job Responsibilities

• Highly skilled in Google Suite and manage shared team drives and complex gCal scheduling requests with both internal and external stakeholders, potentially across multiple time zones
• Proficient in all available tech meeting platforms including in room technology, video conferences, Google Meets, Zoom and global webcasts
• Support the planning and execution of department-wide staff meetings (e.g. Town Halls, department meetings, etc), meeting logistics including agenda creation/distribution, meeting materials, catering, room set-up, etc.
• Support & ensure attendees are prepared to participate in meetings including AV connection, telephony, Zoom info, etc.
• Send communications on behalf of someone (note: complexity depends upon the person requesting)
• Assist in communications for day-to-day team operations, including changes in policies, processes, department reminders (e.g. handling of gifts, etc.), team agreements
• Ensure that employees are recognized for milestones (anniversaries, weddings, birthdays, etc.) based on department guidelines
• Submit facilities, IT, and Site Service requests
• Manage purchase orders, invoices, payment tracking and vendor maintenance
• Manage distribution lists, print services, office supply process and shipping/receiving
• Manage relationships with internal and external stakeholders, often with a high level of confidentiality required
• Coordinate certain logistics of moves (space management), in close collaboration with BAS Business Manager
• Manage and plan team building events & workshops
• Keep up-to-date on available trainings and organize for team and/or other admins in department
• Process and manage vendor/speaker engagements, contracts and payments, etc.
• Arrange for conference registration, business travel and hotel accommodations, submit business expense reports as needed
• Upon request, may edit and enhance documents including presentations
• Manage the hiring process by scheduling candidate interviews, arranging candidate travel (if applicable), manage all logistics for interview day, and administrative onboarding of new hires
• Manage administrative components and logistics of onboarding (ensure new hires have information for orientation, welcome events, new devices, etc.)
• Manage departmental gSites, Currents, websites, newsletters, etc. (collect content, distribute information, oversee maintenance)
• Assist with managing department documents (electronic and hard copy), such as contracts, memos, including sending out and retrieving off-site storage boxes as needed
• Assist with coordinating CRO visit logistics, including setting up CRO personnel on-site visits, meeting setup, and providing logistic related information to CRO personnel
• May assist in managing the manuscript internal peer review process
• Work with other admins in BAS and the Business Manager to plan BAS events and provide coverage as needed

Required Skills and Qualifications:

• Min 10 years related administrative, operations or project management experience (experience gained in pharmaceutical / biotechnology industry is preferred.)
• Experience working with senior leaders/management
• Ability to handle routine and impromptu assignments with minimal supervision and 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
• In depth knowledge of Microsoft Office (Powerpoint, Excel and Word), cSuite Tools (including gMail, gCal, gSheets, gSlides, Trello, Lucidchart, gMeet, ZOOM) and able to provide instruction or training to others as needed
• Familiarity with large, matrixed organization preferred
• BS/BA degree plus 10 years exp

Pay Rate Range: $30-39/hr depending on experience 
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Join Our Team as a PV Governance Specialist – Drive Excellence in Pharmacovigilance!

Are you a seasoned PV professional with a knack for governance and stakeholder engagement? We are seeking a dynamic PV Governance Specialist to play a pivotal role in our global pharmacovigilance operations. This is an exciting opportunity to contribute to a forward-thinking organization, ensuring regulatory compliance, streamlining processes, and collaborating across diverse teams. If you thrive in a hybrid work environment and are ready to make an impact, we want to hear from you!

What You’ll Bring:

• 3-5 years of comprehensive experience in pharmacovigilance, with exposure to a broad spectrum of PV activities beyond just adverse events.
• Demonstrated ability to lead and give clear directives to cross-functional departments while confidently managing stakeholder relationships.
• Proven experience with PV tracking tools or similar systems, ensuring accurate oversight and compliance.
• Exposure to vendor management and audit processes, enhancing overall governance and quality assurance.
• Excellent communication skills, with the ability to liaise effectively across various levels of an organization.

Nice To Have:

• Familiarity with PV governance frameworks and program management.
• Experience working with international teams and regulatory agencies.
• Additional certifications or training in PV or compliance fields.

Preferred Education and Experience:

• Bachelor’s degree or higher in a relevant field such as life sciences, pharmacy, or healthcare.
• Past experience in a global PV environment, ideally within a pharmaceutical or biotech setting.

Other Requirements:

• Location: Maidenhead, UK – hybrid model (1-2 days in the office per week).
• Contract length: 12 months, with an immediate start preferred.
• Stakeholder engagement, vendor interactions, and audit exposure preferred.

Ready to make a meaningful impact in pharmacovigilance governance? Apply now to be part of a innovative team dedicated to excellence and patient safety!
]]> Fri, 06 Mar 2026 00:00:00 EST 1
Key Responsibilities
• Responsible for the expansion, maintenance, cryopreservation, and thawing of multiple cell lines. This includes ensuring proper handling of cell lines and preparation of media with complex supplements.
• Collaborate with team members to assess cell culture needs and provide necessary support for ongoing research activities.
• Engage with various functional areas to evaluate cell culture and cell banking needs and deliver materials according to defined timelines.
• Understand quality control procedures to validate cell lines as needed to ensure experimental integrity.
• Maintain accurate, detailed laboratory notebooks and relevant documentation for all laboratory activities.
• Opportunities to contribute to the development and implementation of genetically modified cell lines and in vitro cell-based assays to support various Oncology projects.

Basic Qualifications
• B.S. degree in Molecular Biology, Cell Biology, Cancer Biology, or a related life science field, with a minimum of 3 years of hands-on experience working with cancer cell lines, primary cells, and genetically engineered cell lines.
• Expertise in aseptic technique and mammalian cell culture, including handling multiple cell lines simultaneously and preparing media with complex supplements.
• Excellent organizational skills, attention to detail, and proficiency in record keeping.
• Familiarity with cell culture quality control practices such as mycoplasma testing and cell line authentication.

Preferred Qualifications
• B.S. degree in Molecular Biology, Cell Biology, Cancer Biology, or a related life science field, with a minimum of 6 years of strong hands-on experience in mammalian cell culture in the biopharmaceutical or biotechnology industry.
• Proficiency in using electronic lab notebooks for experiment documentation, inventory management, and workflow execution.
• Experience optimizing and troubleshooting mammalian cell culture systems.
• Exceptional organizational skills with meticulous attention to detail and data integrity.
• Strong written and verbal communication abilities.
• Experience in writing and maintaining standard operating procedures (SOPs)
• Experience with online genetic databases and the ability to advise on integrating relevant phenotypic and genetic information into our cell bank management systems.
• Experience with biology techniques such as viral and non-viral transduction or transfection methods (e.g., lentivirus, retrovirus, lipid-based systems).
• Experience and familiarity with laboratory instruments such as plate readers, cell counters, and automated western blot systems.
• Ability to run basic cell assays and develop cell line banking protocols.
• Adaptability in a fast-paced environment with shifting priorities and timelines.

Pay ranges between 32-39.85/hr based on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1
This is what you will do:
This company is seeking an Associate Scientist III to join our integrated Viral Vector Production and Molecular Assessment team. In this cross-functional role, you will support reliable production of recombinant adeno-associated viral (rAAV) vectors across upstream and downstream unit operations while executing molecular and biochemical assays to characterize product quality, genomic integrity, and process-related impurities. You will work closely with Process Development, Manufacturing, QC/Analytics, Genomic Medicine, and Viral Vector Product Development to enable robust AAV processes, timely analytics, and data-driven decisions. You will also review data, author technical reports and SOPs, and contribute to method development and assay qualification.

You will be responsible for:
• Upstream operations: Assist with cell expansion, transient transfection, and bioreactor operations (Ambr250, Wave, 50 L stir-tank).
• Downstream operations: Participate in clarification, TFF, depth filtration, and chromatography (affinity/ion exchange); assemble/disassemble and clean harvest-train components; stage materials and ensure equipment readiness.
• Molecular/biochemical analytics: Perform routine in-process sampling and monitor process parameters. Execute qPCR/ddPCR (titer), endotoxin and % empty/full capsid assays to characterize AAV products and process intermediates.
• Contribute to experimental design, assay qualification, documentation, and data trending.
• Sample management: Coordinate sample plans across unit operations; ensure accurate labeling per SOPs, maintain chain-of-custody, and enable timely delivery for analytics with clear priorities.
• Data capture and analysis: Record process and analytical data in batch records, logbooks, and ELN; compile results, analyze trends, yields, and performance; author run summaries, technical reports, and presentations.
• Cross-functional collaboration: Represent the group on program teams with Upstream/Downstream Process Development, Manufacturing, QC/Analytics, Supply Chain, and Facilities; provide training and troubleshooting support.


You will need to have:
• BS in Biochemistry, Molecular Biology, Analytical Chemistry or related field with 4+ years of relevant experience, or an MS with 2+ years of experience.
• The ideal candidate will have a strong background in molecular biology, biochemistry, or related fields, with hands-on experience in vector production / analytical characterization of viral vectors.
• Experience in the operation or oversight of laboratory operations, in terms of sample testing, inventory, and equipment maintenance.
• Demonstrated ability to utilize standard office software (Excel, PowerPoint, Word, etc.), data analysis software (GraphPad, etc.), and ELN software.
• Strong organizational and time management skills, ability to prioritize multiple demands and work efficiently under pressure.
• The duties of this role are mostly conducted in a lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; PPE gowning; use of a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.]]> Fri, 06 Mar 2026 00:00:00 EST 1  

• Oversee clinical supply activities, encompassing label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management.
• Facilitate timely startup of new studies through prompt supply availability.
• Manage the Clinical Supply program for investigation drug product inventory management and distribution in partnership with CMOs; evaluates drug utilization versus forecast considering country requirements and logistical timelines.
• Responsible for the oversight of Clinical Supply CMOs.
• Responsible for the management of global strategies in IRT systems.
• Responsible for the creation, periodic review, and maintenance of all Clinical Supply SOPs.
• Accountable for initiating, overseeing, and resolving departmental deviations.
• Collaborate with cross-functional teams (Clinical Operations, QA, CMC, and Regulatory) to ensure optimal execution of Clinical Supply strategy and identify and address potential risks to the progression of clinical programs proactively.
• Function as the internal point person for addressing product issues, temperature excursions, and deviations originating from clinical sites or depots. Collaborate with Quality Assurance to address any quality-related matters.
• Serves as the primary representative/subject matter expert (SME) during all inspections and clinical supply chain audits.
• Serve as a subject matter expert and devise continuous improvement plans for clinical supply GMP, GDP, and business processes.
• Assist in ongoing drug accountability and reconcile end-of-study drug inventory.
• Provide clinical supply and risk mitigation recommendations.
• Oversee inventory management of study drug and comparators at depots.
• Mentor CSC team members as needed on programs and systems.

Requirements:

• B.S. in a scientific, healthcare, or related field with 10+ years of global clinical supply chain experience within the biotechnology sector. APICS certification is advantageous.
• Proven history of establishing, refining, and managing clinical supply chains within the biotechnology industry.
• Solid understanding of GMPs, GCPs, GDPs (GxP) requirements
• Strong attention to detail with excellent follow-up.
• Progressive knowledge of Import/export regulations, including pro-forma invoice generation, import regulations, and global trade compliance.
• Previous successful collaboration & management of third-party CRO’s and CMO clinical supply operations.
• Strong experience of GxP & Systems including development of specifications, oversight of system operations, troubleshooting & identifying gaps, performing set-up & testing of systems, & understanding areas of limitations, risks, or gaps to mitigate. (IRT).
• Exceptional written and verbal communication, with diligence, collaboration, ability to manage complex challenges, and influencing skills.
• Excellent planning, organizational skills, and the ability to work simultaneously on multiple projects with tight timelines.
• Experienced in assisting, as the Clinical Supply Chain SME, during Regulatory Inspections and Audits.
• Proactive in driving performance cross-functionally and fostering collaboration.
• Ability to build/drive internal team consensus.
• Translates broad strategies into specific objectives and action plans.
• Proficient knowledge of MS Office (Smartsheet, Excel, PowerPoint, Visio, Project, etc.) 

]]> Fri, 06 Mar 2026 00:00:00 EST 1
Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives. Travel is required. Excellent verbal, written, interpersonal and presentation skills are required. Working knowledge and experience with Word, PowerPoint and Excel. Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials. Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures. Ability to develop tools and processes that increase measured efficiencies of the project. Must be able to anticipate obstacles and proactively develop solutions to achieve project goals. Must have a general understanding of functional issues and routine project goals from an organizational perspective.

Pay ranges between 45-54/hr based on experience]]> Fri, 06 Mar 2026 00:00:00 EST 1
Manager, Accounts Payable:

Manage team members - check in on workload, items requiring attention/escalation, review of responsibilities and project coordination.

Bank Recs - work with GL/Treasury to address and resolve any and/or unreconciled items.

NTT Quality Tracker - attend monthly meetings to review and discuss items reflected on the tracker for BPI; work alongside NTT for issue resolution when necessary

Duplicate Invoice/Payment Report - review monthly findings provided by AP associate for any necessary AP action

Escalated Issues - teams first line of escalation for questions and or problems.

Metrics - review weekly data and perform data analysis for trends, unresolved holds, repeat offenders so as to provide necessary guidance on PO/invoice monitoring in hopes of increased PO requester/buyer involvement to reduce said holds.

Project Management/Involvement - get involved with and initiate projects alongside internal/external stakeholders to create better systems, efficiencies, processes.

Financial Disclosure Requests - review for accuracy prior to submitting to Regulatory team

SOX & Auditor Requests - provide requested information and attend annual meetings to review SOX controls

Backup to Senior AP associate, AP analysts and AP associate when they are OOO/PTO]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target Pay Rate: 34-38/hr **salary will be commensurate with experience 

The Opportunity
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support projects.

• Designs experimental plan to support project objectives.
• Executes bench experiments; makes detailed and general observations and analyzes data.
• Prepares technical reports, summaries and quantitative analyses.
• Normally acts independently for developing methods, techniques and evaluation criteria for obtaining results.
• Identifies and implements improvements to work processes and laboratory environment.
• Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Participates or leads cross functional technical teams such as a failure investigation or core team.
• Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.
• Troubleshoots problems and institutes corrective action.
• Prepares and presents experimental procedures and results in group and project teams.]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target PR: 36.25–45.00/hr DOE

Overview
Implementing a First Sale for Export (FSFE) operating model to optimize customs valuation and intercompany flows. This role will manage day?to?day FSFE transaction execution between Singapore Manufacturing (SG01), Singapore Global Distribution Center (GDC / SG05) and U.S. Distribution Centers, ensuring each intercompany sale, shipment, and handover aligns compliantly to the commercial terms, forecasting constructs, and documentation flows.

Responsibilities

• Monitor the intercompany order chain (Manufacturer? Distributor? Recipient) to ensure compliance between physical shipments and commercial documents (PO/SO, invoice, pack list, CoO, export docs) across first and second sale events.
• Translate consensus forecast and IBP supply plan into intercompany POs/SOs, delivery schedules, and shipments. Monitor daily stock transfer order (STO) signals and reconcile exceptions to avoid partial/late deliveries and remain compliant with supply agreements.
• Identify capacity or material?lead?time constraints at SG01, quantify risk to FSFE cadence, and coordinate mitigation (reschedules, split shipments, cancellations).
• Generate and route supply agreements and change requests to Toll for review and approval.
• Serve as point of contact between Supply Chain, Toll, Legal, Internal Audit, Accounting, Customer Care functions to ensure timely execution of FSFE processes.
• Validate exporter of record, incoterm, ship to/ship from, carrier, delivery windows, labeling/packaging markers per contract clauses, and correct master data if needed.
• Review stock transfers and weekly consolidation between legal entities. Monitor customs holds daily and resolve with Trade Compliance team.
• Maintain audit logs and provide documents upon request to Toll, Global Trade Compliance, Legal, Internal Audit, Accounting, and other functions as needed to maintain compliance.

Qualifications

• 5+ years in supply planning, DRP, distribution/logistics operations, and/or global trade compliance in a multinational environment.
• Demonstrated experience operating within intercompany supply chains and executing first?sale or multi?leg valuation models (manufacturing? principal? distributor).
• Experience with SAP IBP, APO and/or ECC preferred.
• Experience with iCertis or other Contract Lifecycle Management (CLM) systems for routing intercompany agreements and amendments.
• Proficient in collaboration tools (i.e. Microsoft 365, SharePoint, Teams)
• Comfort reading and operationalizing supply agreements, contracts and pricing/forecast schedules (incoterms, title/risk, delivery windows, invoice timing).
• Strong documentation discipline for customs/audit (pack lists, CoO, valuation support, exporter/importer data).
• Life-sciences or regulated industry background preferred, including familiarity with product compliance, labeling/packaging controls, and quality interfaces.
• Relentless execution focus with high attention to detail; thrives in transaction?heavy, exception?driven environments.

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target PR Range: 61-71/hr
*Depending on experience

Purpose:

As a member of the Vendor Strategy and Relationship (VSR), this role delivers operational and strategic value across the full vendor lifecycle. The role provides subject matter expertise (SME), fosters strategic alignment with vendors, and supports innovative, sustainable growth through operational excellence. The role ensures effective partnership management by centralizing expertise, standardizing processes, optimizing performance, and proactively managing risks and trends within the Therapeutic Areas (TA), organization and vendor(s).

This role leverages both operational experience with strategic insight to align study, TA and Portfolio decisions with enterprise vendor strategies.

 

Responsibilities:

• Execute vendor selection strategies with business and study teams.

• Lead early engagement activities with study teams and vendor, advising on TA design risks, trends and key considerations.

• Lead internal vendor study kick-off meeting, co-lead joint vendor and study team kick-off meeting.

• Conduct 2nd round review on key vendor documents (e.g., contracts, study specifications) to ensure quality and alignment.

• Provide financial health support to study teams.

• Manage partnership escalations, including internal communications; support study-level escalations per escalation plan.

• Educate study teams on database lock and close-out processes, provide guidance and risk mitigation support.

• Develop TA/partnership standards, training resources, and deliver JIT training at key milestones to study teams; lead multi-study lessons learned and share across TA(s).

• Identify, lead or contribute to partnership enhancements; support partnership training and drive TA change management efforts.

Qualifications:

• Bachelor’s degree (or ex-US equivalent) is preferred, in a relevant field as business economics, science or health administration.

• Must have 6+ years of clinical development experience (and/or applicable work experience); including 3+ years (and/or applicable work experience); working with global third-party vendors.

• Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).

• Demonstrates subject matter expertise within vendor category (e.g., capabilities, processes, technical) as well as relationship and leadership competencies.

• Strong interpersonal, negotiation, communication, conflict resolution and problem-solving skills.

• Expertise in analyzing complex business problems and data to design and implement innovative solutions.

• Excellent cross-functional partnership skills; experience managing complex and cross-functional initiatives to achieve objectives, timelines and change management

• Ability to influence internal/external stakeholders and drive decision-making in a collaborative working environment that allows for the appropriate levels of involvement and decision-making.

*CO/NYC candidates might not be considered
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target PR Range: 61-71/hr
*Depending on experience

Overview
Join our International Customer Excellence PMO group supporting high-impact global business transformation, strategic programs, and product launches within a matrixed pharmaceutical environment. We’re seeking contractors who thrive in dynamic settings, partner well across regions and functions, and help drive operational excellence aligned with organizational growth.

Key Responsibilities:
• Execute PMO activities to enable aligned project delivery across multiple functions, regions, and affiliates
• Support and maintain industry-standard PMO processes, tools, and reporting methodologies to ensure consistency, governance, and transparency
• Collaborate with international commercial and marketing teams to facilitate smooth communication, touchpoints, and delivery of key initiatives
• Assist senior PMO leads and project managers in risk management, resource planning, and performance tracking for initiatives spanning business transformation, strategy, and launches
• Prepare project status reports, summaries, and presentations for stakeholders and sponsors
• Help coordinate cross-functional meetings and workshops (e.g., town halls, council sessions), ensuring logistical and content alignment

Skills, Experience, Education:
• Bachelor’s degree required
• Minimum 3 years’ experience managing matrixed, cross-functional, or global projects/programs (business transformation, strategic initiatives, product launch, etc.)
• Strong written and verbal communication skills; English fluency required
• Ability to engage with diverse stakeholders and teams in a global environment
• Familiarity with PMO methodologies, tools, and frameworks (specific certifications/tools TBD)
• Pharmaceutical industry exposure a plus but not required

Preferred:
• Project management certifications advantageous
• Direct experience supporting international initiatives or teams
• Experience preparing project reporting for senior management
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target PR Range: 52-62/hr
*Depending on experience

Summary: The Channel Metadata Analyst supports Digital Lab with day-to-day management, oversight, and optimization of marketing metadata and digital operational programs. This role will also cover aspects of Email Rental, Preference Center management, and dashboard/data operations.

Responsibilities:
• Lead daily operations, including metadata tagging and dashboard management across complex brand programs, ensuring accuracy and on-time execution
• Collaborate with internal stakeholders and agencies to maintain updated content, align processes, and uphold data management standards
• Utilize Salesforce (CPMT) for metadata activities
• Perform data querying, analysis, and process automation using SQL
• Develop and maintain documentation such as playbooks, guides, and RACI matrices
• Onboard cross-functional/agency teams on workflows and operational processes
• Partner with teams to gather requirements, test, and verify data inputs/outputs
• Drive standardization, automation, and process improvements to enable greater efficiency
• Troubleshoot issues, identify root causes, and implement corrective actions with partners
• Design, update, and maintain dashboards/operational reports using Smartsheet, Workfront, & PowerBI
• Oversee and support aspects of Email Rental and Preference Center workflows and operations
• Stay current with digital operations best practices and recommend new solutions
• Communicate clearly and set expectations throughout operational processes

Qualifications:
• Bachelor’s Degree in Business, Marketing, Information Systems, or equivalent experience
• Experience with digital marketing operations, database/content management, project management.
• Hands-on experience with Smartsheet, PowerBI, and Salesforce; proficiency in SQL (Snowflake) & Marketo a strong plus
• Exceptional communication and collaboration skills across business and technical teams
• Demonstrated ability to operate independently, solve problems, and manage multiple priorities in a dynamic environment
• Proven track record of cross-functional teamwork and driving programs to completion
• Strong knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Enthusiastic, solution-oriented, and open to new challenges
]]> Fri, 06 Mar 2026 00:00:00 EST 1
8 months
Location: Boston, MA ( but can be remote)
Bill rate: $60/hr
Pay rate: 41.38
HM Mariko Aoki

This is what you will do:
The Clinical Supply Specialist is responsible for supporting clinical supply managers/leads in developing a robust clinical supply planning and execution function and capability for the company's rapidly growing and dynamic clinical pipeline.

Reporting to the Director, Global Clinical Supply and being part of the PDCS-CSM (Product Development and Clinical Supply - Clinical Supply Management) team, this position will be responsible for task-based activities within clinical supply chain, packaging/labeling operations, distribution, and systems support.

You will be responsible for:
• Support clinical supply managers in ensuring clinical supply timelines for assigned clinical studies are met.
• Direct/oversee and schedule contract manufacturing packaging, labeling, and international shipping/distribution operations for IMP (Investigational Medicinal Product) ensuring on time delivery to support clinical trials.
• Support clinical supply managers to ensure all documentation required to set up packaging and labeling activities in time for study start is created. Support clinical supply managers with preparation for resupply packaging and labeling operations.
• Create shipment orders and liaise with external distribution vendors to ensure shipments are processed correctly and delivered on time; resolve any issues with shipments as needed.
• Ensure required import/export documentation is provided for shipments as needed.
• Maintain inventory management for assigned projects by interfacing with vendors to ensure that inventory systems are kept up-to-date, and that final product reconciliation is accurately completed.
• Be part of the Clinical Supply Management team to ensure operational performance is being achieved and improvement initiatives are being delivered, including ownership of smaller initiatives.
• Gather documentation for quality related activities as necessary (CAPAs, deviations, change controls)
• File documents in eTMF and conduct PQCs.
• Possibility of quarterly travel to Boston office

You will need to have:
• BS/BA degree in supply chain/logistics or pharmacy/drug development discipline or equivalent qualification
• 1-3 years of experience in a (clinical) supply chain / logistics environment
• Familiarity with pharmaceutical/clinical supply chain environment
• Desire to increase knowledge within clinical supply chain area.
• Good planning, organizational and analytical skills
• Ability to prioritize and meet deadlines.
• Strong diligence
• Strong and clear communication skills
• Proficiency with personal computers and Microsoft Office Products, including Word, Power Point, and Excel

We would prefer you to have:
• eTMF experience
• Clinical supply management]]> Fri, 06 Mar 2026 00:00:00 EST 1
This includes but is not limited to:
• Respond to medical information inquiries from health care professionals, patient/consumers, field staff, internal business partners and other customers utilizing standard medical response documents or by creating ad hoc responses as appropriate
• Ensure medical accuracy of advertising, promotional and scientific materials as part of Copy Review Committee and Medical Review Committee, in collaboration with Medical Information Managers and Medical Directors; and ensure the scientific information is consistent with product labeling where appropriate
Monitor scientific literature for potential adverse event reports; report findings to Product Safety within established timeframes
• Research and conduct detailed analyses of the scientific literature for the companies marketed products, investigational compounds, competitor products/compounds, and related disease states. Contribute to communication, reporting and storage of findings
• Develop, review, and/or update standard medical responses, AMCP dossiers, FAQ documents and other medical information resources
• Provide scientific support for assigned stakeholders on ad hoc projects and/or initiatives

Knowledge/Skills Required
• Advanced bioscience degree required (PharmD preferred)
• Demonstrated scientific knowledge and expertise, Oncology experience preferred
• Prior knowledge and understanding of US regulatory standards related to pharmaceutical manufacturers communications and dissemination of medical information
• Excellent verbal and written skills, with demonstrated experience in medical writing and development of scientific communication materials
• Superior literature database search skills, as well as expert literature evaluation and summarization skills
• Minimum of 1-3 years of experience in pharmaceutical industry-based medical information or related discipline

Pay ranges between 45-51.70/hr based on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 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

 ]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target Pay Rate: 100-112/hr **salary will be commensurate with experience 

Contribute to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (e.g. clinical trial implementation), and oversight of all aspects of clinical development working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverables
• Contribute to the development of the program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP)
• In collaboration with the Medical Director, contribute to the development of clinical and regulatory documents, annual safety updates, and registration dossiers (i.e., protocol, ICF, IB, annual safety updates, study reports, regulatory submissions) to support registration and commercialization of the compound(s)
• Participate in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities)
• Lead the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis
• Provide medical input for country/site selection, feasibility assessment and engage in KOL interaction
• Prepare charters and coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation Committee, DMC, Steering Committee, and Safety Committees)
• Participate in the development and review of study plans and serve as a liaison to project teams and CROs
• Provide input for the development of publications in coordination with Scientific Communications
• Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
• Mentor junior level Clinical Research Scientists as required

•PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline
• Minimum requirement:10+ years of experience in clinical research with at least 3 or more years of drug development experience (preferably in oncology/hematology)
• Experience working in a project-oriented matrixed team environment
• Strong communication skills - both oral and written]]> Fri, 06 Mar 2026 00:00:00 EST 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 ]]> Fri, 06 Mar 2026 00:00:00 EST 1
Job Purpose:
The primary responsibility of this position is to transport assigned operational components, supplies and materials to requesting departments as well as transport full pallets of finished goods to storage and staging areas, loading and unloading trailer for delivery with a power and pallet jacks in a timely manner, observing all safety regulations and ensuring all cGMP and quality standards are met and to maintain the efficient flow of product through the production process. Individual will complete SAP needed transactions to request components for production and perform inventory adjustments.

Major Accountability:
• Possesses required knowledge of SOP’s, cGMP’s, procedures, SAP entries and has the ability to explain the requirements to others as needed.
• Independently utilizes required Personal Protective Equipment and Safety Gear and performs a safety check on equipment to be used in the daily operations and ensure that all safety devices are functioning properly.
• Responsible for the movement of WIP materials within the warehouse.
• Communicates with Lead Operators and Management to maintain an efficient flow of material through the production process. Checks Compounding and Production schedules for batches to be run, transports materials and supplies to point of use staging area with the appropriate PIT equipment
• Responsible for the activities associated with the processing of finished goods for outbound deliveries.
• Keeps assigned areas clear and clean and transports unused components back to storage as required. Performs SAP inventory transactions, as required, to keep WIP inventory and Bin locations accurate.
• Responsible for overall housekeeping and organization of WIP Warehouse, including cycle counting, reconciliation and material destructions. Cleanliness of pallets/material containers, ensuring cleanliness and good condition of materials delivered to manufacturing. Also, maintain overall housekeeping of Production Staging Areas in Packaging, including cycle counting and reconciliation.
• At the end of shift, secure all equipment, perform general housekeeping duties and accurately complete all required paperwork.
• Performs other duties as assigned
• Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)

• Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would 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
• Participate in Behavioural Based Safety Program (BBSP) by complying with all safety procedures and preventive measures (i.e., wearing Personal Protective Equipment (PPE), following lockout/tagout procedures).
• Ability to work independently and as part of a team in a fast in a fast-paced environment to meet the departments daily productivity and replenishment requirements.
• Demonstrated ability to manage multiple tasks simultaneously and be able to react to shifting priorities to meet business needs
• Demonstrated technical skills and knowledge of warehouse processing
• Strong team player; open to assisting with any task in order to get the work completed
• Quick learner; able to establish rapport and develop relationships
• Must be able to identify and recommend improvements.
• Ability to learn and apply new software multimedia applications
• Ability to lift up to 50 lbs.
• Ability to stand for extended periods of time

Education/ Experience/ Background
Education: High School diploma or equivalent
Languages: Fluent in written and spoken English
Experience: 4 years of related experience]]> Fri, 06 Mar 2026 00:00:00 EST 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

]]> Fri, 06 Mar 2026 00:00:00 EST 0
The Bioconjugation and Delivery group in the Protein Sciences organization is responsible for the design and generation of new therapeutic modalities that combine the engineering and analytical principles of multiple scientific disciplines. We are excited to be at the forefront of therapeutic design by generating molecules with unique mechanisms of action. We are seeking a talented early-in-career Scientist to join our team to advance our mission by learning and applying advanced bioconjugation techniques with precise analytical characterization. This position offers hands-on experience in drug development, including protein bioconjugation.

This position is located in South San Francisco and is an on-site laboratory research position.

Key Responsibilities

• Bioconjugation of proteins utilizing chemical and/or enzymatic conjugation methods, including reaction design and optimization.
• Development, optimization, and implementation of purification protocols of bioconjugates using common protein purification techniques.
• Analytical characterization of reaction mixtures and purified conjugates employing chromatographic techniques (e.g. SEC, HIC, IEX), SDS-PAGE, colorimetric assays, as well as 1D and 2D mass spectrometry.
• Data reporting, interpretation of results, and data presentation to internal teams.
• Sample management of completed conjugates and related starting materials using internal inventory systems.
• Collaboration with scientists from multiple functional and therapeutic areas at Genentech to advance molecules through the drug discovery pipeline.

Required Education:

• Must have attained a Bachelor's Degree or higher.

Required majors:

• Chemistry, biochemistry, chemical biology, biophysics, biology, biomedical engineering, or related fields.

Required skills:

• Basic understanding of protein purification and analytical techniques.
• Previous experience with FPLC, HPLC or LCMS.
• Excellent communication, collaboration, and interpersonal skills.

Other Preferred Qualifications:

• Previous experience with oligonucleotides and/or antibody oligonucleotide generation

Pay Rate Range: $40-51/hr depending on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1 Scientific Researcher
Synthetic Molecule Pharmaceutical Sciences
Position Summary
We are seeking an outstanding Scientific Researcher to support formulation screening efforts within the Synthetic Molecule Pharmaceutical Sciences group. The successful candidate will contribute to the development and optimization of lipid nanoparticles (LNPs) and other parenteral formulations through high-throughput screening strategies and advanced analytical characterization. This role requires hands-on laboratory expertise, strong analytical skills, and the ability to work collaboratively within cross-functional teams to support pharmaceutical formulation development.
Responsibilities

• Design and execute high-throughput formulation screening experiments for lipid nanoparticles (LNPs) and other parenteral drug delivery systems, using both bench instruments and automation tools.
• Physicochemical characterization of LNPs including particle size distribution, encapsulation efficiency, zeta potential, stability testing, etc.
• Solubility and stability screenings, solid state/polymorph characterizations to support formulation research and development.
• Design, plan, and troubleshoot laboratory experiments while maintaining strong attention to data quality and reproducibility.
• Analyze and interpret experimental data, generating clear reports, presentations, and summaries for project teams.
• Document experimental procedures and results in electronic laboratory notebooks (ELN) and internal data management systems.
• Collaborate with analytical scientists, formulation scientists, and cross-functional project teams to support development programs.
• Identify technical challenges and propose potential solutions to improve formulation performance and experimental workflows.
• Maintain compliance with laboratory safety standards, internal quality requirements, and regulatory guidelines.

Required Qualifications

• BS or MS degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.
• 1 - 5 years of industrial experience in pharmaceutical formulation research and development.
• Strong theoretical knowledge of pharmaceutics; analytical, physical, and/or organic chemistry.
• Hands-on experience with LNP formulation and analytics, including microfluidics, dialysis and ultrafiltration, particle sizing, encapsulation efficiency analysis.
• Self-motivated with strong problem-solving capabilities to design and execute experiments independently.
• Excellent written and verbal communication skills to work effectively in a collaborative team environment.

Preferred Qualifications

• Hands-on experience with analytical tools including UV/Vis/fluorescence spectroscopy, HPLC-UV/CAD/MS, capillary electrophoresis, or related technologies.
• Experience in analyzing peptides and nucleic acids.
• Experience with lab automation and hands-on experience with robotic liquid and solid handlers.
• Experience performing high-content data analysis, AI/ML, and interpreting complex experimental results.

Key Skills

• Pharmaceutical formulation development
• LNP and parenteral formulations
• High-throughput experimentation
• Analytical chemistry techniques
• Data analysis and interpretation
• Laboratory automation technologies
• Scientific problem solving
• Cross-functional collaboration

Pay Rate Range: $35-47/hr depending on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1 HM's Top Needs:

1. 
   3 or more years of clinical research experience with in industry sponsor. Preferred  med devices.
   
2. Experience with site activation activities
3. Site management activities

Education Required: Bachelor

Years’ Experience Required:
3 and more 
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hrs

Work Location:

                Do they need to be local to any MDT office and if so where? No, it can be remote



Responsibilities may include the following and other duties may be assigned. Oversees, designs, plans and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms. Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets. May be responsible for clinical supply operations, site and vendor selection.

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, 06 Mar 2026 00:00:00 EST 1 OT Engineer - Geleen, Netherlands

Unlock the next step in your career as an OT Engineer in the vibrant city of Geleen, where cutting-edge biotechnology meets innovative technological solutions. This full-time, on-site role offers a unique opportunity to work within a leading company dedicated to advancing Cell and Gene Therapy, ensuring the integrity and compliance of GMP computerized systems. Join a team that values expertise, collaborative spirit, and a commitment to quality in a dynamic and growing environment.

Overview
As an OT Engineer based in Geleen, you will play a vital role in maintaining and validating GMP computer systems, supporting compliance with industry regulations, and driving technological excellence. Your expertise will ensure that laboratory systems operate seamlessly, securely, and in line with regulatory standards, directly contributing to groundbreaking therapies that improve lives. This is a fantastic opportunity for junior to mid-level professionals eager to develop their skills in a highly specialized field.

Required Skills

• Bachelor's degree in Science, Engineering, or a related technical field
• Experience with GMP computerized systems administration and validation
• Familiarity with GxP regulations, GAMP, and validation practices (IQ/OQ/PQ)
• Knowledge of data integrity, 21 CFR Part 11, and Cell and Gene Therapy regulations
• Strong technical writing and documentation skills
• Fluent in English, with excellent oral communication skills
• Ability to troubleshoot, identify issues, and support deviations and change controls
• Effective organizational and time management skills

Nice to Have Skills

• Experience with computer system audits and CAPA implementations
• Knowledge of software change management processes
• Understanding of laboratory information management systems (LIMS) or similar platforms
• Previous exposure to validation projects in biotech or pharmaceutical environments

Preferred Education and Experience

• Minimum of a Bachelor's degree in a relevant scientific or technical discipline
• Prior experience working within GMP environments, ideally in Cell and Gene Therapy settings
• Demonstrated ability to support validation protocols and computer system compliance

Other Requirements

• Full-time availability, on-site work in Geleen, Netherlands
• Ability to collaborate with interdisciplinary teams and end users
• Willingness to support ongoing process improvements and regulatory audits

Take your expertise to the next level in a role that blends technical mastery with the opportunity to contribute to life-changing therapies. If you are passionate about GMP systems, validation, and advancing biotech innovations, we encourage you to apply now and become a key player in this exciting field!
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Applies intensive and diversified knowledge of design principles, practices and implementation in complex systems and assignments. General responsibilities include design concept generation, participating in design reviews, development and testing to assess performance against design specification; reliability testing, and assessment of system interactions. Makes independent decisions. Assist in the development of manufacturing processes and troubleshooting issues to determine root cause and possible engineering solutions.

Job Responsibilities/Qualifications
• Candidates should be able to perform each of these responsibilities satisfactorily to do this job successfully
• Learns to use company concepts, policies and procedures, familiar with and follows standard practices.
• Normally receives detailed directions on all work.
• Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Makes suggestions to improve work processes.
• Assists in reducing to practice patentable inventions.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Participates in technical team activities.
• Presents and discusses data within group.
• Monitors work to ensure quality, and continuously promote Quality First Time.
• Other duties as assigned by management.

Required Skills:
- Knows basic and some specialized engineering techniques.
• Familiar with searching technical literature.
• Skilled with use of word processing, spreadsheets, graphical and presentation software
applications.

Experience/Education:
- Bachelors in Engineering with 4+ years of experience

Pay ranges between 40-45/hr based on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1 Full-time l 12 month contract

A major capital project in the life sciences sector is seeking an experienced LOTO / PTW Specialist to join its EHS team. This role is central to ensuring safe isolations, strong permit governance, and high quality field execution across a complex, high risk environment.
The Role
You will manage project specific LOTO processes and isolation equipment, combining structured coordination with hands on site presence. You’ll support safe work planning, guide stakeholders, and help maintain a strong safety culture throughout the project.

Key responsibilities include:

• Managing the project LOTO office and overseeing isolation processes.
• Supporting safety line walks, coordination meetings and permit discussions.
• Reviewing PTW, job hazard assessments and RAMS for safe task execution.
• Leading and supporting risk assessments with engineers and contractors.
• Verifying LOTO plans through PI&D review and advising on process safety requirements.
• Supervising field EHS performance, including occasional nights and weekends.
• Developing safety communication material and delivering LOTO and process safety training.
• Coaching employees and contractors and escalating issues when needed.
• Supporting the wider EHS team and acting as PTW back up when required.

What You Bring

• 5+ years’ experience with LOTO and PTW in high risk industries (life sciences, energy, petrochemical or similar).
• Experience working on large, complex projects.
• Engineering background or similar technical qualification.
• Strong understanding of barrier management, high integrity, and the ability to work independently and within a small team.

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Fri, 06 Mar 2026 00:00:00 EST 1 The Senior CMC Project Manager, reporting to the Executive Director, Head of Program Management, will lead CDMO coordination and program integration for late-stage cell therapy program. This individual will manage external manufacturing partners ensuring timelines, deliverables, and risks are aligned and visible across the full program. If you are a highly motivated and experienced CMC project management professional passionate about developing innovative cell therapies, we encourage you to apply for this exciting opportunity to join our team.

KEY RESPONSIBILITIES
 

• Drive strategic CDMO partnerships, serving as the primary day-to-day project manager and liaison to external partners ensuring alignment of project plans, timelines, and priorities.
• Oversee CDMO performance and execution, monitoring progress against SOWs, timelines, and quality agreements, and coordinating timely resolution of deviations, delays, or scope changes.
• Manage financial processes including PO creation, invoice review, and budget tracking to ensure on-time, on-budget delivery.
• Lead internal and joint governance meetings, including scheduling, agenda preparation, and follow-up of decisions, risks, and actions. Consolidate CDMO and CMC program updates for dashboards and leadership reporting.
• Build and maintain strong cross-functional relationships, fostering collaboration between company, CDMO and internal SME’s ensuring clear communication and accountability across functions.
• Own CMC project documentation and tools, maintaining integrated timelines, risk registers, decision logs, and action trackers, and ensuring Smartsheet and SharePoint systems are current and standardized
• Align cross-functional teams across Process Development, Manufacturing, Quality, Regulatory, and Supply Chain to ensure integrated planning, clear ownership, and consistent execution of program deliverables

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 a related field (e.g., Project Management, Engineering, Life Sciences)
• 8+ years of experience in Biotech/Pharma setting with 5+ years CMC or external manufacturing project management
• Background in biotechnology or pharmaceutical development, with direct exposure to late-stage cell or gene therapy programs, preferred
• Strong organizational and time management skills, with the ability to prioritize tasks effectively
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Proficiency in Microsoft Office Suite, SharePoint, and Smartsheet
• Knowledge of regulatory requirements related to pharmaceutical or biotechnology projects is preferred

REQUIRED SKILLS AND ABILITIES
 

• Able to and comfortable with travel up to 25%
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
• Must have strong attention to detail and demonstrated decision making ability
• Ability to work individually and in a team environment
• Demonstrated excellence in written and verbal communication skills
• Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships

]]> Fri, 06 Mar 2026 00:00:00 EST 0 Target PR Range: 54-64/hr
*Depending one experience

Job Description: Data Analyst – Global Patient Access Program (GPAP)
Location: North Chicago, IL, USA (Hybrid eligible), AP30
Overview: The Data Analyst for the Patient Assistance Program (PAP), supporting GPAP’s data transformation and governance, will be instrumental in building and maintaining the backbone of automated reporting and KPI dashboards. This role ensures a single source of truth for GPAP operations, drives analytics innovation, and supports the integration and consistency of data across the program. You’ll collaborate closely with workstream leaders, lead in bi-weekly scrum sessions, and deliver insight-rich, timely outputs for senior leadership.
Key Responsibilities:
• Develop, automate, and maintain standardized PAP reporting, KPI dashboards, and ad hoc analytics tools using Tableau, Excel, and Snowflake.
• Lead twice-weekly Scrum sessions with workstream team members, ensuring progression of data tasks, intake of new data requests, and alignment on analytics approaches in a Smart Sheet-driven, agile environment.
• Ensure data consistency, quality, and accuracy across all platforms, supporting GPAP governance and the creation/control of the 'source of truth.'
• Enable and facilitate self-service dashboards and reporting marts for internal and external stakeholders.
• Collaborate with cross-functional partners (BTS, ACA, GPAP, Steer Co) to support program data needs, forecasting, and reporting methodologies.
• Support quarterly and weekly reporting processes—including application, shipment, and claim-level analytics.
• Partners with data lead to document extraction methods, automate/accelerate reporting, and track program impacts, escalations, and business intelligence.
• Identify new opportunities for advanced analytics or insights to increase PAP operational efficiency and program sustainability.
Qualifications:
• Bachelors in a relevant field (Analytics, IT, Business, Data Science, or related)
• 3-5 years’ experience in data analytics, reporting, or business intelligence in healthcare, pharma, or related industry
• Advanced proficiency in Tableau and Excel; experience with Smart Sheet and Snowflake (SQL skills required)
• Demonstrated experience leading agile meetings (scrum/project management preferred)
• Strong attention to detail, data integrity, and quality control
• Experience in KPI development, dashboard design, and self-service reporting
• Effective communicator with ability to drive cross-team consensus and present findings to varied audiences
• Collaborative mindset, able to work in fast-paced, matrixed environments
• In office Tues, Wed, Thurs
Preferred:
• Experience in patient assistance programs or US healthcare market access
• Familiarity with organizational data governance or compliance requirements

Be part of a team unlocking strategic impact through advanced analytics, automation, and insight-driven transformation. Shape the way data informs patients’ access and program value across a global organization while enjoying professional growth in a supportive, inclusive culture.
]]> Fri, 06 Mar 2026 00:00:00 EST 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%.

]]> Fri, 06 Mar 2026 00:00:00 EST 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.

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Pay range: 25-35/hr
*depending on experience

Job Description:
This position supports Patient Data Intake (PDI) organization to achieve its mission of improving patient lives through consistent and accurate delivery of high quality, relevant, and timely adverse event and product quality management by providing effective oversight of external providers of Pharmacovigilance services.

Major Responsibilities:

Core job requirements include:

· Conducting oversight of vendors who identify and collect adverse event information and complete intake of Pharmacovigilance safety reports in Safety System.
Conducting oversight of vendors who identify and collect product quality complaint information and complete intake of Product Quality reports in Product Quality System.
· Conducting oversight of vendors to ensure collection, assessment, and processing of adverse event and product quality complaint information is performed in a compliant and timely manner to comply with global regulations.
· Supporting the business strategy of assisting internal and external customers in collecting information for product safety reports and products complaints related to products.
· Conducting oversight of vendors to ensure company standards for quality, compliance and productivity are met. Remaining current on knowledge and skills required for supporting customers.
· Supporting vendor case quality and productivity metrics by exhibiting the core leadership attributes: Agile and Accountable; Clear and Courageous; Make Possibilities Real; All for One; Decide Smart and Sure.
· Supporting and participating in audits and inspections as needed.
· Supporting development of materials and delivering training in conjunction with the vendor, including train-the-trainer, special-topics, refresher, and internal  trainings as needed.
· Conducting oversight to ensure the vendor is effectively communicating using various mediums and establishing rapport with customers, colleagues, and interdepartmental groups.
· Conducting oversight in the vendors use of multiple databases to document adverse event and product complaint information.
· Supporting implementation of strategies to enhance PDI excellence in providing the highest level of customer experience.
· Acting as an adverse event and product complaint intake subject matter expert.
· Gaining knowledge and expertise to initiate mentoring opportunities of other specialists in PDI.
· Participating in projects/assignments in coordination with management.
· Gaining knowledge and expertise to initiate mentoring opportunities of other specialists in PDI.
· Participating in projects/assignments in coordination with management.
· Other duties may be assigned based on the need or work requirements of the organization.

Experience/Skills:
Bachelor’s degree with related health sciences background. Nursing or Pharmacy preferred
3-6 years clinical healthcare and previous pharmaceutical industry experience. Pharmaceutical industry contact center experience preferred

Provides medical support with emphasis on the intake of medical product experiences and processing standard communication requests. Acts as a liaison with Quality Assurance for product quality problems where an adverse event is involved. Works with Customer Service to provide standard information and product replacement as necessary. Provides assistance to the medical and lay community with standard information that is from the package insert or information from the standard letter database that deals with labeled and specific off-label information/indications.

Experience Level = 3-5 Years

*CO/NYC candidates might not be considered
]]> Fri, 06 Mar 2026 00:00:00 EST 1 EU Healthcare Compliance Manager - London, UK

Are you passionate about ensuring ethical standards and compliance within the dynamic pharmaceutical industry? We are seeking a dedicated EU Healthcare Compliance Manager to join a leading organization in London, offering a hybrid working model with office-based flexibility. This pivotal role is perfect for a proactive professional with a strong foundation in medical affairs compliance, eager to make a meaningful impact across affiliate teams and uphold the highest industry standards.

In this role, you will be at the heart of shaping and maintaining compliance excellence within the European healthcare space. Your expertise will guide medical affairs teams through complex scientific and technical compliance challenges, ensuring alignment with regulatory requirements and industry codes.

Required Skills:

• Proven experience in medical affairs compliance within the pharmaceutical industry
• Hands-on knowledge of guidance and support to affiliate medical teams
• Strong understanding of scientific and technical compliance aspects
• Experience with EPIA or ABPI guidelines
• Excellent communication and stakeholder management skills
• Ability to interpret and apply complex compliance regulations effectively

Nice to Have Skills:

• Prior experience working in European or multinational pharmaceutical companies
• Knowledge of digital healthcare compliance and emerging industry trends
• Additional certifications in pharmaceutical compliance or medical affairs

Preferred Education and Experience:

• Bachelor’s degree or higher in Life Sciences, Healthcare, Pharmacy, or a related field
• Previous roles demonstrating progressive responsibility in compliance, ideally at a junior to mid-level

Other Requirements:

• Willingness to travel within Europe as needed
• Ability to adapt to a hybrid working environment
• A proactive approach and keen attention to detail

This is a fantastic opportunity to join a reputable organization and influence compliance practices at a European level. If you are driven, detail-oriented, and ready to take on this exciting challenge, we encourage you to apply now and help shape the future of healthcare compliance within this innovative company.
]]> Fri, 06 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 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, 06 Mar 2026 00:00:00 EST 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!
 
]]> Fri, 06 Mar 2026 00:00:00 EST 1
Major Accountabilities

•Coordinates, manages and provides ground transportation and logistical support. Maintains close collaboration with the President’s Executive Team.
•Delivery of safe, secure, and uninterrupted ground transportation for the President. Other country leadership members may require / use the service upon request.
•Advance monitoring of local traffic conditions for travel areas and frequent destinations in and around the New Jersey, Pennsylvania and New York Metropolitan areas to ensure uninterrupted transfers.
•In coordination with Corporate Security, develop, implement, and assess ground transportation contingency plans in response to corporate crises scenarios. Rehearse incident responses across a range of scenarios, in alignment with the companies Crisis Management procedures and competent authorities where required.
•Support the preparation of travel security risk assessments (for travel routes and venues) as well as the arrangement of proportionate control and personal protection measures within the areas of travel.
•Maintain a travel log and/or other documentation as required, to ensure compliance with company finance requirements.
•Maintenance of company-owned vehicle(s) ensuring they are serviced, licensed, and kept roadworthy in a condition befitting an executive-level passenger. Ensuring that all equipment within that vehicle is in good operational condition and any necessary inspections are up to date.
•Plan and manage the through-life procurement (from acquisition to divestment) of company-owned vehicles and equipment used for executive transport in line with the companies procurement guidelines. Maintain respective inventories and plans of expenditure.
•Identify, plan, and manage training activities to maintain currency and personal expertise in functional core competencies, including (but not limited to):
• Advanced defensive/evasive driving and legal requirements while driving.
• Incident response, emergency planning and communications procedures.
• Medical first aid.
• Relevant professional certifications.

Key Performance Indicators
Indicate key facts and figures.

•Ensures the safe, timely and precise day-to-day transportation
•Takes the initiative to evaluate risks on a regular basis to ensure route selection is logical, rational, and safe.
•Demonstrates flexible availability to align and accommodate the schedules. Responds to unanticipated changes in plan/or direction without hesitation.
•Impeccable professional behaviors in all interactions. Acts with confidence, restraint, and professionalism in the event of an emergency.
•Maintains strict confidence in all matters related to the position. No loss/leaks/compromise of sensitive or confidential conversation, documentation & material, (verbal, electronic or hard copy).
•Demonstrates maturity in day-to-day business, understanding the need for urgency without overreaction.
•Maintains assigned vehicle(s) in the highest possible standards of safety and appearance.
•Ensures that licensing related to driving is maintained and always in good standing.
•Develops transportation service contingency plans. Tests, document and communicate these plans to ensure seamless service in the event of absence.
•Champions the companies Code of Conduct and Values & Behaviors in all aspects of the role.

Ideal Background
Education
•Advanced driver training, defensive driving required. CPR, First Aid, & AED certification required or be willing to obtain the certification.

Languages
•Fluency in English essential; Knowledge of other languages a plus.

Experience and Skills
•Minimum 5 years professional driving experience required. Possess excellent driving skills in a variety of conditions.
•Requires the highest level of integrity with the ability to keep confidence.
•Knowledge of the NJ, NY and Eastern PA area roadways and routes or ability to acquire such knowledge quickly.
•Possess a valid, active Driver’s License with an impeccable driving record.
•Strong communicator, with an ability to engage and influence stakeholders at every level.
•Resilient and adaptable, with the ability to manage multiple priorities in a fast-paced environment. Ability and Willingness to work long, varied, and unpredictable hours, including on weekends.
•Must have a clean, pressed, and polished professional appearance. May be at times required to wear formal business attire.
•Demonstrate professional & culturally sensitive work ethics.
•Must pass an extensive background and drug screening.]]> Fri, 06 Mar 2026 00:00:00 EST 1 We are looking for a Senior Manager of External Manufacturing Operations to lead the management, implementation, and execution of our CMC strategy at CDMOs. If you are a highly motivated and experienced GMP manufacturing professional with a passion for developing and commercializing innovative drug therapies, we encourage you to apply for this exciting opportunity to join our team.


KEY RESPONSIBILITIES

• Manage operational and technical support of small molecule CDMOs to deliver on late phase clinical and commercial production.
• Lead CDMOs to implement CMC strategy in manufacturing including but not limited to efforts to optimize manufacturing processes, implement process changes, and reduce manufacturing costs.
• Provide on-site CDMO oversight, as needed, to accomplish clinical and routine, commercial production goals
• Provide SME impact assessments on deviation investigations, support CAPAs, and manage proactive initiatives and change controls, as required.
• Lead review and approval for technical reports, risk assessments, batch records, SOP’s, etc. required for cGMP manufacturing. 
• Develop, track, and monitor production data for CMO during clinical manufacturing and PPQ to mature to continued process verification (CPV) during commercial manufacturing.
• Represent External MFG / MSAT on cross functional teams (internal and external) for late stage / commercial CDMO. Act as the internal project team lead for CDMO.
• Ensure operational robustness and efficiency through management and tracking of manufacturing metrics and KPIs 
• Support authoring and review of CMC sections of health authority submissions. Provide immediate response support, as required
• Develop and maintain strong relationships with internal stakeholders and external partners and ensure strong collaboration and productivity to deliver successful late phase, scale-up cGMP clinical and commercial batches
• Other duties as assigned.

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.

• B.S, M.S, or Ph.D. degree in chemistry, chemical engineering or related, scientific discipline required.
• 10+ years of experience w/ a B.S.; 7+ years of experience w/ M.S. or higher.
• 5+ years of experience, in process chemistry/development, MS&T, and/or External Manufacturing for small molecules required. 
• cGMP manufacturing experience required. 3+ years preferred.
• Experience managing production at CDMOs required. 3+ years preferred.
• Experience with late-stage clinical enabling, PPQ and commercialization activities for small molecules preferred

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Experience managing manufacturing activities and CDMOs during clinical/commercial cGMP manufacturing. 
• Strong understanding of cGMP regulations and process chemistry.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.
• Experience authoring and reviewing protocols and reports that support GMP manufacturing, validation, and regulatory (BLA/MAA/etc) filings. 
• Strong analytical and problem-solving skills, with the ability to apply scientific and engineering principles to complex technical problems and data trending.
• Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment.
• Proficient use of MS Office products, JMP or other data analysis software proficiency is a plus
• Travel required up to 20%

]]> Fri, 06 Mar 2026 00:00:00 EST 0 ABOUT THE POSITION

The Senior Cold Chain Engineer will own the design, implementation, optimization, and continuous improvement of LN2 and temperature-controlled supply chain systems supporting research, clinical, and future commercial operations. This role is highly autonomous and requires deep technical expertise, strong project execution skills, and the ability to translate scientific and regulatory requirements into scalable operational solutions. They will be expected to be the primary supply chain contact for various internal and external teams, representing the team in many high-profile projects.


KEY RESPONSIBILITIES

Cold Chain System Design & Engineering

• Design, qualify, and optimize LN2, cryogenic, frozen, refrigerated, and CRT cold chain systems across internal and external networks.
• Lead the selection, qualification, and lifecycle management of: LN2 storage tanks and freezers, Cryogenic and passive shippers, and Temperature-monitoring devices and telemetry solutions
• Define temperature excursion tolerances, hold times, and stability-aligned packaging strategies.

Operational Readiness & Scale-Up

• Build cold chain capabilities to support R&D, clinical trials, and future commercial scale.
• Develop and execute cold chain strategies aligned with Long-term storage requirements and global distribution and site variability
• Serve as the cold chain SME during process development, tech transfer, and scale-up initiatives.

Qualification, Validation & Risk Management

• Lead cold chain IQ/OQ/PQ, lane qualification, packaging validation, and re-qualification activities.
• Author and review validation protocols, reports, and technical assessments.
• Conduct failure mode and risk analyses for cold chain processes and shipping lanes.
• Design and implement mitigation strategies for LN2 and CO2 supply interruptions, equipment failures, and transit risks.

Quality, Compliance & Documentation

• Ensure cold chain operations comply with GxP, and internal quality standards.
• Partner with Quality to develop and maintain:
• SOPs, work instructions, and deviation response playbooks
• Temperature excursion investigation frameworks
• Support audits, inspections, and regulatory readiness activities related to cold chain operations.

Vendor & External Partner Management

• Act as the technical lead for cold chain vendors, couriers, and logistics providers.
• Evaluate vendor capabilities, lead technical due diligence, and support contracting decisions.
• Drive continuous improvement through performance reviews, root-cause investigations, and CAPAs in alignment with Quality.

Data, Monitoring & Continuous Improvement

• Define KPIs and dashboards for cold chain performance (excursions, lane reliability, cost, recovery time).
• Leverage temperature data, shipment analytics, and trend analysis to proactively improve system robustness.
• Champion standardization and best-practice adoption across programs and geographies

Cross-Functional Leadership

• Serve as the cold chain subject-matter expert across Supply Chain, Manufacturing, Quality, Clinical Ops, Commercial Ops, and R&D.
• Translate scientific, regulatory, and operational needs into executable cold chain solutions.
• Independently identify gaps, propose solutions, and drive projects from concept through implementation.
• 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 engineering, supply chain, life sciences, or related technical field (required). Master's degree in engineering, supply chain, life sciences, or related technical field (preferred).
• 7–12+ years of experience in cold chain engineering, logistics, or operations within biotech, pharma, cell/gene therapy, or biologics.
• Relevant certifications a plus: Cold Chain or GDP certifications Six Sigma / Lean methodologies

REQUIRED SKILLS AND ABILITIES

• Hands-on experience with LN2 and cryogenic cold chains (storage, shipping, and monitoring) with biologics.
• Proven track record of owning complex technical projects end-to-end with minimal oversight and ability to operate independently. 
• Direct experience with packaging qualification, lane validation, and temperature excursion management.
• Proficiency in Microsoft Office Suite, DocuSign, and Smartsheet.

 ]]> Fri, 06 Mar 2026 00:00:00 EST 0 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.]]> Fri, 06 Mar 2026 00:00:00 EST 1
ECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor, working under limited supervision, and providing assistance and training to lower level employees. Runs minor projects, including performing tests, interpreting data, developing reports.

Organizational Impact: Performs technical activities requiring considerable judgment and may have ownership of minor projects. Work consists of technical tasks that are typically not routine.

Innovation and Complexity: Technical problems faced are general, and may require some analysis to understand and resolve. Expected to independently propose solutions to problems for supervisor review.

Communication and Influence: Communicates typically with internal contacts . Obtains and provides technical 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 complete and broad knowledge of operational systems, techniques and practices typically gained through extensive experience and/or education.

Requires minimum of 4 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.]]> Fri, 06 Mar 2026 00:00:00 EST 1 Join a Pioneering Leadership Role as Medical Director in Diagnostic Radiopharmaceutical Development

Are you a visionary medical professional with a passion for diagnostic imaging and cutting-edge radiopharmaceuticals? Our client, a research-focused company specializing in innovative theranostics and precision oncology, is seeking a dynamic Medical Director to lead their late-stage development programs globally. This is an exceptional opportunity to make a significant impact on patients' lives through pioneering imaging solutions, all from the comfort of your home—anywhere in Europe or the US.

In this strategic role, you'll oversee and shape the medical and clinical strategies for advanced clinical trials, including pivotal Phase 3 studies focused on primary Aldosterone work. Collaborate with cross-functional teams, drive regulatory interactions with agencies like FDA and EMA, and contribute to the development of transformative diagnostics in oncology and cardiovascular disease. Your expertise will guide the interpretation of imaging data, influence study designs, and support the approval of groundbreaking therapies.

Essential Skills & Qualifications:

• Medical Degree (MD or equivalent) with a strong background in Nuclear Medicine, Radiology, or Diagnostic Imaging.
• Extensive experience in late-stage (Phase 2/3 or Phase 3) oncology or diagnostic development programs.
• Proven expertise in diagnostic imaging modalities, particularly PET/CT and molecular imaging techniques.
• Demonstrated ability to lead clinical trial design, regulatory interactions, and benefit–risk assessments.
• Strong understanding of clinical trial methodologies, regulatory expectations, and data interpretation.
• Excellent communication skills in English; proficiency in German is advantageous.
• Ability to operate effectively within a small, agile, matrixed environment.

Nice to Have Skills:

• Experience working specifically on diagnostic imaging or radiopharmaceuticals in global regulatory contexts.
• Prior involvement in trials targeting CXCR4 or similar receptors.
• Familiarity with international regulatory landscapes beyond FDA and EMA.

Preferred Education and Experience:

• Medical Degree with specialization in Radiology, Nuclear Medicine, or related fields.
• Significant experience, ideally 8+ years, in leadership roles within clinical development of radiopharmaceuticals or diagnostic imaging agents.

Other Requirements:

• Home-based work arrangement with flexibility—no location restrictions in Europe or the US.
• Ability to manage multiple stakeholders and thrive under a fast-paced, resource-lean environment.
• Fluency in English; German language skills are a plus.

This is a rare chance to influence the future of diagnostic medicine and work at the forefront of radiopharmaceutical innovation. If you're ready to lead impactful clinical programs in a collaborative, science-driven environment, we encourage you to apply now and take the next step in your career.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Join Our Innovative Team as Head of Clinical Development – Brachy

Are you a visionary leader with a passion for advancing cancer treatment through cutting-edge radiotherapy? Do you thrive in a collaborative environment where clinical expertise meets strategic innovation? We are seeking an exceptional Head of Clinical Development – Brachy to spearhead our clinical initiatives, drive market development, and shape the future of brachytherapy solutions. This is your chance to lead a talented team at the forefront of medical technology, working directly with management and influencing global strategies—all while making a tangible difference in patients’ lives.

In this role, you will own and expand our clinical brachy functions, translating clinical proof points into compelling value propositions, and influencing reimbursement strategies. You will develop and execute clinical market development plans, collaborate with product management to optimize workflows, and oversee clinical claims and risk management activities. As a key member of the management team, your strategic vision and clinical insights will be instrumental in elevating our solutions and positioning us as a leader in the field.

What You'll Bring:

• A Medical Doctor or PhD in Biomedical Studies with 10+ years of industrial clinical experience.
• Proven leadership in developing and executing clinical strategies in oncology, imaging, nuclear medicine, or radiotherapy.
• Experience managing clinical teams (8-10 professionals) with strong people management skills.
• Extensive knowledge of brachytherapy, radiotherapy, or related fields—experience in brachytherapy is highly desirable.
• Ability to translate clinical data into actionable insights for product development and marketing.
• Familiarity with clinical workflows, regulatory processes (EMA, FDA), and reimbursement pathways.
• Excellent communication skills, capable of engaging with stakeholders at all levels.

Nice to Have Skills:

• Background in Medical Device or diagnostics.
• Experience in interventional radiology, interventional oncology, theranostics, or radiopharmaceuticals.
• Strong business acumen with the ability to think strategically and commercially.
• Fluency in Dutch, with openness to relocating or extensive in-country presence.

Preferred Education and Experience:

• MD or PhD with a minimum of 10 years' relevant industry experience.
• Demonstrated success in strategic leadership roles within clinical development.
• Prior experience in managing budgets and cross-functional teams in a fast-paced environment.

Other Requirements:

• Willingness to work onsite in Utrecht, Netherlands, with a flexible approach to relocation support.
• Openness to travel as needed to support clinical activities and stakeholder engagement.

If you are ready to lead innovative clinical initiatives that transform cancer care and want to be part of a dynamic management team, we invite you to apply and take the next step in your leadership journey. Join us in shaping the future of brachytherapy—where your expertise can truly make a difference.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Group QA, RA & H&S Manager
 

Join a Fast-Growing Leader in Veterinary Healthcare—Drive Quality, Compliance, and Safety Across the UK & EU

Are you a passionate and experienced Quality, Regulatory Affairs, and Health & Safety professional looking to make a significant impact within a rapidly expanding healthcare organization? We are seeking a dynamic Group QA, RA & H&S Manager to lead our compliance efforts, uphold high standards, and foster a culture of safety and quality across our UK and EU operations. This full-time, office-based role offers the opportunity to shape our compliance framework within a forward-thinking, high-growth environment, reporting directly to Senior Leadership.

Required Skills:

• Over 5 years of proven leadership experience in QA, RA, and H&S functions within regulated industries
• Strong working knowledge of MDR 2017/745, ISO 9001, and ISO 14001 standards
• Experience managing H&S compliance, risk assessments, and incident investigations
• Analytical mindset with proficiency in data-driven decision-making and Excel
• Excellent communication and stakeholder engagement skills
• Demonstrated ability to lead change management initiatives
• Self-motivated, organized, and able to work independently with minimal supervision

Nice to Have Skills:

• Knowledge of ISO 13485 standards
• Prior experience as a PRRC (Person Responsible for Regulatory Compliance) or EU Responsible Person
• Background in medical, veterinary, or healthcare product supply chains
• Experience with e-QMS software implementation and management

Preferred Education and Experience:

• Relevant degree in life sciences, healthcare, or a related field
• Extensive experience in regulated environments with a track record of maintaining ISO certifications and regulatory compliance

Other Requirements:

• Office-based with some flexibility for remote work
• Willingness to spend most of the week onsite
• Ability to travel within the UK and EU if required
• Certifications in H&S (e.g., NEBOSH) are advantageous

If you are a proactive leader eager to drive continuous improvement, ensure operational safety, and shape a culture of excellence, we invite you to take the next step in your career with us. Apply now to join a company where your contributions will help redefine standards in veterinary healthcare and beyond.
]]> Fri, 06 Mar 2026 00:00:00 EST 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

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Senior Manager, Regulatory Affairs

Join a pioneering leader in the biopharmaceutical industry as a Senior Manager of Regulatory Affairs, where your expertise will directly impact the development and delivery of innovative medicinal products worldwide. In this strategic role, you will lead regional regulatory strategies, oversee critical agency interactions, and ensure compliance across multiple product portfolios. Your contributions will be vital to maintaining timely approvals, supporting clinical trials, and shaping the future of healthcare solutions.

What You’ll Bring:

• Extensive knowledge of regional legislation, regulations, and policies related to medicinal products
• Proven experience in developing and executing regulatory strategies for clinical trial and marketing applications
• Strong track record of managing regulatory submissions and negotiations with health authorities
• Exceptional leadership skills with the ability to guide and collaborate across cross-functional teams
• Excellent communication capabilities, adept at translating complex regulatory information into actionable insights
• Analytical mindset with the ability to assess regulatory risks and develop contingency plans

Nice to Have Skills:

• Experience managing or supervising regional regulatory teams or support staff
• Familiarity with expedited pathways such as orphan drug, accelerated approval, and compassionate use programs
• Knowledge of industry best practices in labelling, regulatory documentation, and agency negotiations
• Multilingual proficiency and cultural sensitivity for international collaboration

Preferred Education and Experience:

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field; advanced degrees (e.g., Master’s or PhD) are advantageous
• A minimum of 8+ years of regulatory affairs experience within the biopharmaceutical or healthcare industry
• Prior involvement in product development phases from clinical trials through to commercialisation

Other Requirements:

• Ability to work primarily remotely with occasional on-site presence in Uxbridge (approximately one day per month)
• Flexibility to support a 12-month contract with an immediate start preferred
• Willingness to stay abreast of evolving global and regional regulatory landscapes and contribute to strategic initiatives

If you are a strategic thinker with a passion for advancing healthcare through effective regulatory leadership, we invite you to bring your expertise to this dynamic role. Take this opportunity to make a meaningful impact—apply now and help shape the future of life-changing medicines.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 The Administrative Assistant position provides professional administrative services to improve operating efficiency for the US-based R&D executive leadership team. This role will report to the VP of Global Regulatory Affairs - US, and under direct supervision, will support leaders across several US R&D teams to plan, prioritize, communicate and organize workloads, including US Regulatory, Global Patient Safety, Clinical Operations, and Patients Insights and Quality. Specific support responsibility will be focused towards the administrative duties in support of the VP of Global Patient Safety -US and the VP of Global Regulatory Affairs.

Essential Functions:
Provides professional administrative support to the US based R&D leadership, which may include:

• Provide prioritized administrative support, including calendar, travel, and expense management support for VP of Global Patient Safety -US and the VP of Global Regulatory Affairs
• Maintain cross functional calendars for US R&D leaders, including Regulatory, GPS, Clinical Operations, Patients Insights and Quality
• Schedule, coordinate, and execute hybrid (in-person/virtual) meetings
• Serve as the home office/ US based liaison for R&D visitors, which may include scheduling meetings, coordinating travel, and executing necessary visit logistics
• Help organize US based R&D team events, along with department leadership
• Serve as US based R&D point of contact for new employee onboarding for home office
• Create documents and presentations using Word and/or PowerPoint as directed
• Coordinate travel arrangements for US based R&D leadership, in line with company travel policy
• Compile and process expense reports
• Coordinate interview schedules for the US based R&D leadership and their direct reports
• Initiate Purchase Orders, including applicable signatures and payment coordination needed to maintain compliance
• Aggregate and submit contracts and SOWs to the appropriate internal systems and track progress towards signature
• Coordinate US R&D recruiting, onboarding and system/ building access needs for US based R&D team members, as requested.
• Support and maintain US R&D information management, as directed
• Support US based Regulatory and GPS teams, as well as other US R&D personnel, as needed
• Other miscellaneous duties as assigned, including administrative tasks that support US R&D and require home office (non-virtual) support

Required Education, Experience, and Skills:

• High School Diploma/GED
• 3+ years of administrative experience supporting multiple individuals in a fast-paced environment, including meeting, calendaring, and global travel management
• Ability to handle day-to-day activities for a busy department while meeting important deadlines on a variety of projects
• Proficient in MS Word, Excel, PowerPoint, and Outlook
• Clear and professional, written, oral, and interpersonal skills
• Solid internet research abilities
• Excellent organizational and time management skills with the ability to multi-task
• Ability to handle sensitive information with the highest degree of integrity and confidentiality
• Demonstrated initiative and flexibility
• Ability to work well in a team and hybrid environment
• Ability to accomplish set objectives with minimal supervision
• Detail oriented and self-motivated

Preferred Education, Experience, and Skills:

• Accredited BS/BA degree
• Demonstrated experience with sharepoint, and other internet based tools, eg travel and meeting management tools
• 3+ years direct R&D department experience
• Experience in the pharmaceutical industry

Travel:

• No overnight travel requested unless unique circumstances arise

]]> Fri, 06 Mar 2026 00:00:00 EST 0 Project Manager, Global Demand and S&OP Capability Lead

Join a world-class organization as a Project Manager, leading the deployment of Demand and Sales & Operations Planning (S&OP) capabilities within a dynamic, global supply chain environment. This pivotal role offers the chance to drive strategic initiatives, influence digital transformation efforts, and develop innovative solutions that impact global operations. If you are a seasoned supply chain professional with a passion for continuous improvement and cross-functional collaboration, this opportunity is for you.

What You’ll Do:

• Lead the deployment of Demand and S&OP capabilities across multiple regions, ensuring operational excellence in People, Process, Technology, and Data domains.
• Collaborate with stakeholders across GSC Pillars, IT, finance, and other teams to execute strategic workstreams and deliver measurable business benefits.
• Drive system adoption, configuration, User Acceptance Testing (UAT), and analytics integration to enhance forecasting and planning accuracy.
• Develop and implement governance practices, ensure process compliance, and manage change initiatives to facilitate seamless adoption.
• Track, analyze, and report operational KPIs, tailoring metrics to specific project scopes to support business realization.
• Support talent development through training, documentation, and knowledge sharing, fostering a culture of high performance.
• Manage stakeholder relationships, champion digital tool investments, and articulate the value of new technologies.
• Lead risk management activities, scenario analysis, and strategic recommendations to stakeholders.
• Promote an inclusive environment that recognizes high-team performance and aligns with company values.

Required Skills:

• Minimum of 8 years’ experience in Supply Chain Management, with a proven track record in Demand Forecasting and S&OP/S&OE processes.
• Strong leadership in cross-functional project management and deployment of digital supply chain tools (e.g., SAP IBP, Kinaxis, Power BI, Tableau).
• Expertise in process improvement methodologies, including Lean and Six Sigma certifications preferred.
• Exceptional communication, stakeholder management, and negotiation skills.
• Ability to analyze complex problems, drive solutions, and influence decision-making at various organizational levels.
• Experience managing change and driving system adoption initiatives.
• Familiarity with regulatory standards such as cGMP, FDA, and pharmaceutical manufacturing practices.

Nice to Have Skills:

• Advanced certifications like APICS CSCP/CPIM or operational excellence Green/Black belt.
• Background in biotech or pharmaceutical manufacturing processes.
• Experience in risk management and scenario planning.
• Knowledge of project financial management and ROI analysis.

Preferred Education and Experience:

• Bachelor’s degree in supply chain, management, engineering, biology, chemistry, or related field; a Master’s or MBA is preferred.
• Relevant experience in biotech or pharmaceutical sectors.
• Proven success in deploying complex digital solutions and leading high-performing teams.

Other Requirements:

• Willingness to work approximately 2–3 days per week in office
• Flexibility to participate in two interview rounds, including a panel interview with senior leaders.
• Ability to travel occasionally if required.

If you are ready to make a significant impact in a cutting-edge field, embrace digital transformation, and lead impactful supply chain initiatives globally, we encourage you to apply now. Take the next step in your career and join a team committed to excellence and innovation in supply chain management.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 We’re supporting a global Life Science organisation in the search for a (Senior) Marketing Communications Manager to lead the development and execution of high impact communication strategies across Europe. This is a broad, hands on role suited to someone who thrives in a fast moving, cross functional environment and has proven experience engaging pharmaceutical manufacturers as a core audience.

You’ll take ownership of annual planning, campaign execution, and content development across multiple channels, working closely with commercial, product, and regional teams to drive awareness, demand, and brand impact.

---

The Opportunity
This role is ideal for a well rounded marketing communicator — someone who has touched digital, content, branding, product launches, events, campaigns, and lead nurture. You’ll shape European level strategy while staying close to execution, ensuring materials, messaging, and campaigns land with clarity and consistency.

---

What You’ll Do Strategy, Planning & Execution

• Develop and execute annual marketing communications strategies for the European region.
• Own project planning, timelines, and budget management to ensure efficient delivery.
• Partner with commercial teams to tailor messaging for pharmaceutical manufacturer audiences.

Campaigns & Branding

• Lead omni channel campaigns that drive awareness, engagement, and demand across Europe.
• Strengthen brand positioning through consistent messaging, storytelling, and visual identity.
• Develop and refine value driven narratives for key commercial priorities.

Content Development

• Create and manage high quality marketing materials including:
  • Web content
  • Videos
  • Expert interviews
  • Interactive tools
  • Sell sheets and collateral
  • Webinar content
• Test and measure material effectiveness, using data to refine messaging and format.

Demand & Lead Generation

• Design and execute lead generation and nurture programs in partnership with sales and digital teams.
• Build content journeys that support prospect engagement and conversion.

Product Launches

• Plan and execute European level product launch communication strategies.
• Create messaging frameworks, launch toolkits, and cross channel campaigns for internal and external audiences.

Events & Trade Shows

• Oversee communication activities for events, ribbon cuttings, photo and video shoots.
• Develop concepts, content, and on site materials for regional trade shows and conferences.

---

What You Bring

• 5+ years of Marketing Communications experience at European level.
• Demonstrated experience engaging pharmaceutical manufacturers as a target audience.
• Broad marketing communications background covering multiple areas, not a single channel specialist.
• Proven experience in:
  • Digital marketing
  • Content creation
  • Product launches
  • Demand generation & nurture
  • Branding
  • Omni channel campaigns
  • Collateral/material development and performance testing
  • Event and trade show management
• Strong project management and budget ownership experience.
• Excellent communication skills and the ability to develop compelling, insight driven content.
• Creative mindset with strong organisational skills and attention to detail.
• Ability to work cross functionally in a fast paced, international environment.

]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target PR Range: 36-36/hr
*Depending on experience
Major Responsibilities:
• Perform cGMP cell-based potency assays testing in support of the manufacture of biologics products. Responsible for the timely completion of assigned laboratory testing.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance.
• Generate and update SOPs.
• Adhere to and supports all EHS standards, procedures and policies.
• Understand regulations and business processes required to maintain laboratory data integrity.
• Maintain and comply with laboratory documentation and computerized systems data integrity requirements.


Regulated Responsibilities (including cGMP and EHS):
Regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.




Qualifications:
• MS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 3+ years of relevant industrial experience or BS in Chemistry/Biochemistry/Cell Biology or a related Biological Science field with 5+ years of relevant industrial experience.
• Proficiency in quality systems, Microsoft Project, and Excel.
• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.
• Experience with aseptic cell culture and cell banking preferred.
]]> Fri, 06 Mar 2026 00:00:00 EST 1
The Opportunity:
As a Scientist, you will provide testing support for product and process research and development (including design, development, analysis, troubleshooting, etc). You will apply sound experimental design, perform complex scientific research to support research and development of product formulations and/or analytical methods.

As a Scientist, you should possess an in-depth knowledge and experience in the field of analytical chemistry, electrochemistry, biosensors, in-vitro diagnostics, and/or biomedical engineering. You should also possess and will need to apply a broad knowledge of principles, practices and procedures of your respective field. Your duties will be dynamic and complex often involving research, analysis, and solution development.

Applies deep and intensive knowledge of scientific principles.
Performs laboratory based studies and experimentation to generate data relevant to various product development projects across Diagnostics, specifically, the Diabetes Care portfolio.
Test and assess innovative technologies as part of our Research and Early Development Scouting efforts.
Participates in interdepartmental or cross-functional decisions on projects.
Independently identifies technical objectives and opportunities, as well as risks and alternatives.

Bachelors degree in Chemistry, Biochemistry, or a related Life Sciences field with 5 years of relevant experience or
Master of Science/PhD with 2 years of relevant experience
2+ years of experience in, biomedical or analytical chemistry
2+ years of experience in the field of biosensors

Preferred:
More than 5 years of progressive work experience in an appropriate scientific field.
Previous Lab based role / safety focused role
Applies scientific principles in a broad range of technical assignments, making independent decisions based on sound scientific reasoning and analysis
Highly organized and able to manage multiple parallel projects and work packages

Pay ranges between 40-45/hr based on experience ]]> Fri, 06 Mar 2026 00:00:00 EST 1 Target PR Range: 44-54/hr
*Depending on experience
 

Job Qualifications:
• Bachelor’s Degree, or equivalent education, with typically 7 or more years’ experience or a master’s degree or equivalent education with 3 years’ experience in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar area. (PhD with 0+ years' experience acceptable).
• Experience in pharmaceutical manufacturing or sterile product filling
• Understanding of regulatory requirements for injectable products

Key Responsibilities
• Supporting the process development of parenteral drug products; small molecules or biologics, preferably with experience in the PFS development including but not limited to defining and optimizing the filling parameters involved in the syringe filling process within pharmaceutical manufacturing operations.
• Design and execute studies evaluating the stability (chemical & physical) of oxygen sensitive products, biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), to develop robust dosage forms.
• Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
• Demonstrated scientific writing skills and strong verbal communication skills.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Pay 45-55/h depending on experience

HM's Top Needs:

• Experience in PSUR and PMCF writing in compliance with the European Union Medical Device Regulation (EU MDR), including PMS data analysis and risk–benefit evaluation.
• Strong expertise in clinical literature analysis, including systematic searches, critical appraisal, and clinical data synthesis.
• Solid project management skills with the ability to manage timelines, coordinate stakeholders, and ensure timely deliverables.
• Proficient in Microsoft Office, particularly advanced MS Word (structured formatting, templates, track changes, and document control).

Education Required:

Baccalaureate degree (Preferred Degree in Life Sciences, Pharmacy, Medicine, Biomedical Engineering, or Public Health, ideally with training in Clinical Research or Regulatory Affairs. : 2yrs-5yrs (see job description in VNDLY)

Years’ Experience Required:

Minimum 3 years, maximum 10 years of relevant experience in PSUR and PMCF writing,  clinical evaluation, or post-market surveillance.

Will the contractor be working 40 hours a week? If not, weekly estimate?

Yes 

 

Work Location: On-site preferred; remote work is acceptable depending on candidate profile pool and experience.

                Do they need to be local to any MDT office and if so where? No, but if they local to Lafayette, Colorado or MN campus that would be great, otherwise remote is acceptable.





Responsibilities may include the following and other duties may be assigned.
Author Periodic Safety Update Report and Post Market Clinical Follow Up  Plan /Reports.
Expereince with EU MDR Regulation 
Review and summarize scientific literature. Reports instances of complaints/adverse events from literature to GCH. Create responses for audit/submission queries. Maintains database of peer-reviewed literature. Appraise, analyze, summarize, and discuss clinical evidence from all the available sources. Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence. Develop state of the art on product family for its intended purpose. Create & maintain plans and reports for regulatory authorities. Review/approve other documentation for device development. Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.

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: 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 decision-making. 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 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 2 years of relevant experience
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Senior Manager, GMP Quality

Seeking a Senior Manager, GMP Quality who will play a key role within Quality Assurance and is responsible for providing leadership and operational support for programs through different phases of development.

Responsibilities:

• 
  Responsible for providing QA support for batch disposition, quality record ownership, and management of QA activities.
  
• 
  Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.
  
• 
  Collaborate with internal and external stakeholders and execute quality systems as the QA SME on deviation investigations, CAPA plans, change controls, shelf-life extensions, revisions to documentation, and other Quality processes.
  
• 
  Lead efforts for QA oversight of the manufacture, validation, and disposition of pre-clinical, clinical, and commercial product materials, including drug substance (DS), drug product (DP), and final product (FP) at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, and other functions.
  
• 
  Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.
  
• 
  Provide Quality oversight as well as review and approval of CMO documentation (e.g., specification documents, Method Validations, Stability records, Master Batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and perform product dispositions.
  
• 
  QA lead in periodically reviewing and revising GMP-related SOPs and procedures.
  
• 
  Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug product validation requirements.
  
• 
  Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations.
  
• 
  Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.
  

Required Skills, Experience and Education:

• 
  A Bachelor's degree in a scientific or technical discipline is required.
  
• 
  A minimum of 8 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and validation, is required.
  
• 
  Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs.
  
• 
  Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness.
  
• 
  Experience in Inspection Readiness (domestic and ex-US).
  
• 
  Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing are strongly desired.
  
• 
  Knowledge of applicable US and Global compliance regulations and industry practices.
  
• 
  Ability to critically evaluate and troubleshoot complex problems with diligence.
  
• 
  Strong teamwork, collaboration, and management skills.
  
• 
  Ability to manage multiple priorities and aggressive timelines.
  
• 
  Highly responsible, self-motivated professional with enthusiasm and passion for the work.
  
• 
  Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).
  

Preferred Skills:

• 
  Experience in auditing vendors and suppliers is preferred.
  

]]> Fri, 06 Mar 2026 00:00:00 EST 0 We’re partnering with a well?established organisation seeking a proactive Accounts Assistant to support their busy Finance team. This is a brilliant opportunity for an AAT Part?Qualified professional looking to broaden their experience across all areas of finance.

In this role, you'll help keep daily operations running smoothly, managing client contract entry, raising purchase orders, supporting month?end close, and handling bank postings and reconciliations. You’ll liaise with Shared Services on AP/AR queries, maintain master data, assist with external audits (including SOX controls), and help drive departmental efficiency improvements. You’ll also produce and update balance sheet reconciliations and provide support across the team when needed.

We’re looking for a confident communicator with strong organisational skills, good SAP knowledge and solid Excel ability including pivot tables and formulas. You should be comfortable working under pressure and meeting deadlines in a fast?paced environment.

If you’re eager to develop your finance career within a supportive team and gain experience across a wide range of tasks, we’d love to hear from you.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Fri, 06 Mar 2026 00:00:00 EST 1 Target PR Range: 31-41/hr
*Depending on experience

SUMMARY/JOB PURPOSE: 

This role is responsible for providing Drug Safety expertise and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs).  This role provides support for all major tasks and oversight of outsourced vendors, related to the management and best utilization of case processing activities in the Argus Safety Database, ensuring compliance with global clinical safety and pharmacovigilance regulations and Global Patient Safety department procedures in all aspects of drug safety case processing and reporting.

This role provides support and oversight of all aspects of drug safety study operational activities from study start up to close out.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Technical duties include but are not limited to:

• Processing and assessing SAEs from receipt to case closure in the Argus database, including query generation, narrative, and ASE writing.
• MedDRA coding of SAEs and AEs as reported in source documents of SAE reports and development/revision of MedDRA Coding Conventions to ensure consistent data categorization.
• Defining and applying a high standard of case quality review to ensure sound medical safety data documentation with the support of the Drug Safety Physician.
• Scheduling submissions of expedited safety reports in ARGUS as needed.
• Training of new safety staff on Argus and case processing.
• Collaborating with other departments (Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, Project Management) to ensure appropriate collection and handling of safety data.
• Performing Safety Study Lead activities including:
  • Review of, Investigator Brochures, study protocols and participation on IND Annual Reports in support of the Drug Safety Physician.
  • Development of study specific safety management plan from Drug Safety template
  • Development, review and update of drug safety forms and templates, and harmonization with relevant clinical operation forms and templates (i.e., SAE data collection form and CRF)
  • Perform SAE reconciliation, as required by safety management plan.
• Additional duties and responsibilities as required.

 

SUPERVISORY RESPONSIBILITIES:

• None

 

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: 

Education/Experience:

• BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or,
• MS/MA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 5 years of related experience; or,
• PhD in Nursing, Pharmacy, other clinical, or related discipline and 0 or more years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

 

Experience/The Ideal for Successful Entry into Job:

• Experience in Biotech/Pharmaceutical industry and/or in oncology preferred.
• Experience using Argus safety database preferred.
• Clinical trial and spontaneous adverse event processing experience.

 

Knowledge/Skills:

• Knowledge of biotechnology/pharmaceutical sector.
• Knowledge of regulatory framework governing patient safety.
• Adopts an analytical approach to solve problems relevant to the role.
• Demonstrates an understanding of organizational and planning capabilities by managing own time and resources to complete assigned work.
• Leads self by managing and executing own work to deliver results that contribute to accomplishing common departmental goals.
• Provides verbal and written communications that are clear and easy to understand. Keeps management informed of potential issues in a timely manner.
• Works collaboratively with team members.
• Good interpersonal skills, understanding of differing views and participation in developing agreed upon resolution.
• Trains on procedures, tasks and tools for role, supported by ongoing coaching and/or mentoring by departmental peers. Develops and maintains knowledge of cross-functional products, tools and data sources. May mentor junior team members.

 

JOB COMPLEXITY:

• Capable of following predefined procedures for specific tasks.
• Capable of identifying task-related challenges and prioritizing activity accordingly.
• Identifies and escalates issues that may have a broader impact.
• Implements solutions to address any task-related challenges.

*CO/NYC candidates might not be considered
]]> Fri, 06 Mar 2026 00:00:00 EST 1 Fri, 06 Mar 2026 00:00:00 EST 1 Target PR Range: 79-89/hr
*Depending on experience

The Project / Operations Manager will play a key role in supporting the Discovery Research organization by driving talent strategy and fostering culture & engagement initiatives. This position will collaborate with the Director of Strategy and Culture, Business HR, leadership teams, and project teams to implement programs that drive high-performing team excellence and support our workplace culture.

Responsibilities:
• Collaborate with leaders to execute talent strategy plans, including talent support/sponsorship, onboarding, and career development programs.
• Implement strategy and plans for culture and engagement, in alignment with Discovery Research and R&D strategies, governance structure, project management structure and progress reporting.
• Develop and manage processes for measuring and improving employee engagement, wellbeing, and organizational culture within Discovery Research.
• Lead project coordination for culture and engagement initiatives (e.g., employee surveys, feedback sessions, recognition programs, onboarding, leadership forums).
• Support and/or build SharePoint and Unily sites for complete transparency and communication across organization.
• Track, analyze, and report metrics related to engagement, retention, and talent development.
• Identify opportunities for continuous improvement in talent and culture-related processes.
• Support change management efforts as new programs or initiatives are rolled out.

Qualifications:
• Bachelor’s degree in Business, Human Resources, Life Sciences, or related field.
• 5+ years of project or operations management experience, ideally within a research or technical environment.
• Strong organizational, communication, and stakeholder management skills.
• Experience managing talent, engagement, or culture initiatives.
• Analytical mindset; comfortable with data and metrics.
• Ability to work collaboratively and drive projects to completion.
This role is critical for promoting a positive, inclusive, and high-performing culture within Discovery Research, ensuring alignment between talent strategy and organizational goals.
]]> Fri, 06 Mar 2026 00:00:00 EST 1 *Depending on experience

Lets do this. Lets change the world. The North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance

Responsibilities:
• Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.]]> Thu, 05 Mar 2026 00:00:00 EST 1 Sales Administrator

Join a dynamic team as a Sales Administrator where your organizational skills and sales support expertise will play a vital role in driving business growth. Based in Hertfordshire, this hybrid role offers the perfect blend of on-site collaboration and flexible working, providing an exciting opportunity to contribute to a thriving sales environment. This 12-month contract with the potential for future opportunities is ideal for motivated professionals eager to make a measurable impact within a renowned organization.

What You’ll Bring to the Table:

• Strong organizational and administrative skills, with experience supporting sales functions
• Ability to prepare sales forecasts, budgets, and quotas accurately
• Proficiency in managing online sales and marketing systems, ensuring data integrity
• Analytical mindset with the ability to conduct statistical analysis on sales data to support strategic decision-making
• Effective communication skills to instruct and collaborate with sales, marketing, and support teams
• Detail-oriented approach to handling sales calculations and incentive budgets

Nice to Have Skills:

• Experience with sales forecasting systems or CRM platforms
• Knowledge of sales incentive programmes and commission calculations
• Familiarity with IT systems related to sales and marketing data management
• Previous exposure to project management or cross-functional initiatives

Preferred Education and Experience:

• University Degree in a relevant field
• At least 2 years of practical experience supporting sales or related functions, or an advanced degree with less experience
• Demonstrated competence in administrative support within a professional environment

Other Requirements:

• Ability to operate predominantly on-site with some flexibility for hybrid working
• Commitment to working within internal compliance frameworks and confidentiality standards

This is a fantastic chance to showcase your skills in a role that offers autonomy, variety, and the opportunity to contribute significantly to the sales team’s success. If you’re ready to take your career to the next level and thrive in a collaborative, forward-thinking environment, we want to hear from you—apply now and start making an impact today!
]]> Thu, 05 Mar 2026 00:00:00 EST 1
The position of Technical Manufacturing Chemist is within the Infectious Disease (ID) business unit located at Scarborough, Maine. In this role you will produce material for use in immunology-based chromatography and enzyme tests.
(This job description is reviewed periodically and is subject to change by management.)

RESPONSIBILITIES:
• Maintains and supports the production schedule
• Investigates problem areas and areas of desirable improvement
• Undertakes new procedures and observes proper safety precautions
• Responsible for in-process QC testing of manufacturing material as it relates to
qualifications, quality inspections and titration.
• Maintains quality systems and proper GMP/GLP
• Creates and follows protocols designed around product improvement
• Responsible for making critical and non-critical bioreagents for use in product and manufacturing processes using Standard Operating Procedures (SOPs).
• Works in a team setting and coordinates manufacturing efforts based upon a set
production schedule and maintaining the raw bioreagent supply as needed to support this schedule.

BASIC QUALIFICATIONS | EDUCATION:
• Bachelors Degree in a Chemistry, Life Sciences, or related field or equivalent
combination of education and experience.
• Prior Experience in the following areas:
o Pipette
o Spectrophotometry
o HPLC
o pH meters
o Gel Electrophoresis o SDS Page
o ELISA assays

COMPETENCIES:
• Ability to work successfully as a member of a team and independently with moderate supervision.
• Skill in using computer applications including spreadsheet, database, manufacturing, and word processing software Provides reasonable accommodation to qualified individuals with disabilities.

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

Pay ranges between 25-28/hr based on experience ]]> Thu, 05 Mar 2026 00:00:00 EST 1 *Depending on experience

Applies skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines.

Key Responsibilities:
• Use tools - needles, scissors, forceps, specialized tooling, microscope - to perform assigned steps, in rotation, in the sewing assembly of valves
• Perform verifications, against specifications, of completed steps, and successive checks on steps completed by work team colleagues
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records
• Other incidental duties: General work area housekeeping

Preferred Additional Skills:
• Preferred Previous sewing, GMP, clean room, medical device experience
• Basic computer skills required
• Good hand eye coordination, required
• Due to the specific duties of this job, you must be able to read, comprehend, write, and speak English
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Must be able to work in a team environment and with minimum supervision by following detailed manufacturing instructions
• Successful completion of ongoing job training of assembly process steps
• 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

Education/Experience:
• High school diploma or GED required.
• 0-2 years experience required.]]> Thu, 05 Mar 2026 00:00:00 EST 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

]]> Thu, 05 Mar 2026 00:00:00 EST 1
Introduction:
The Senior Administrative Assistant position within the Pharmacovigilance team is integral to the effective operation of Global Patient Safety (GPS). Serving as a primary support to the Head of Global Pharmacovigilance and the wider GPS team, this role requires a blend of advanced administrative capabilities, collaborative skills, project coordination, and strong organizational acumen. The following overview details key responsibilities, expectations, and the professional competencies required for success in this important capacity.

Position Structure and Reporting
This position directly supports the Head of Global Pharmacovigilance, who provides strategic and operational leadership for GPS. The Senior Administrative Assistant is positioned at the core of departmental activities, requiring sound judgement, discretion, and the ability to effectively engage with stakeholders across departments. As a central point of contact, the assistant facilitates communication and supports a wide range of operational and project-based needs.
Primary Responsibilities

The Senior Administrative Assistant’s core duties include:
• Meeting Coordination: Proactively schedule and organize meetings and conference calls, ensuring availability of all participants, reserving meeting spaces, arranging technical setup, coordinating catering, preparing materials, and recording minutes as needed. The assistant must anticipate and resolve scheduling conflicts to ensure meetings are productive and well-attended.
• Offsite Event Management: Oversee logistics for offsite meetings, including hotel and restaurant bookings, catering arrangements, and planning team-building activities. This responsibility involves thorough research, negotiation, and organizational skill to deliver seamless events in line with departmental objectives.
• Travel Coordination: Arrange all business travel in accordance with company policy, managing flight, accommodation, and transportation bookings while adhering to budgetary and compliance requirements and considering traveler preferences.
• Expense Management: Prepare and process expense reports accurately and promptly using systems such as Concur, ensuring full documentation and timely reimbursement.
• Office Supply Oversight: Monitor and replenish departmental supplies, ensuring availability of materials necessary for daily operations.
• Technical Liaison: Serve as the point of contact for IT-related issues, facilitating timely resolution and supporting ongoing productivity for GPS team members.
• Meetings Participation: Actively participate in GPS meetings, both on-site and off-site, contributing to effective communication and operational continuity.

Additional Departmental Support
• Calendar Management: Maintain and coordinate calendars for GPS leadership and the broader department, preparing for and supporting team and staff meetings.
• Contract Administration: Submit and track department contract requests within the contract management system, ensuring accurate status monitoring.
• Invoice Tracking: Monitor and reconcile departmental invoices, ensuring financial accuracy and timely payments.
• Project Tracking: Develop and maintain departmental project trackers and spreadsheets, follow up on deliverables, and synthesize information for status reporting.
• Document Management: Organize and maintain departmental files within the document management system, ensuring accessibility and safeguarding institutional knowledge.
• Contact List and Organizational Chart Management: Regularly update departmental contact lists and organizational charts to reflect changes and facilitate efficient communication.

Core Competencies
• Planning and Coordination: Ability to manage multiple tasks and priorities in a fast-paced, deadline-driven environment while maintaining attention to detail.
• Technical Proficiency: Advanced knowledge of Microsoft Office Suite, Concur, SharePoint, and other business tools required for efficient workflow.
• Communication and Interpersonal Skills: Strong written and verbal communication skills to foster professional interactions with internal and external partners.
• Detail Orientation and Responsiveness: Commitment to meeting deadlines and ensuring thorough, accurate, and compliant work products.
• Initiative and Independence: Demonstrated ability to work independently, quickly learn new tasks, and proactively anticipate departmental needs.

Qualifications and Experience
• Minimum 5 years’ administrative experience in the biotechnology or pharmaceutical industries. Experience supporting pharmacovigilance functions is highly desirable.
• Bachelor’s degree highly preferred]]> Thu, 05 Mar 2026 00:00:00 EST 1 Neuroscience B2B Manager (Remote – UK/ROI Focus)

Are you passionate about transforming healthcare and driving impactful business growth in the neuroscience sector? We are seeking a dynamic Neuroscience B2B Manager to lead our efforts in expanding partnerships and market presence within the private healthcare industry for Alzheimer’s care across the UK and Republic of Ireland. This is an exciting opportunity to leverage your expertise in account management, market analysis, and stakeholder engagement to shape the future of neuroscience solutions in a fast-paced, innovative environment.

In this role, you will be instrumental in identifying new business opportunities, building and nurturing relationships with key healthcare stakeholders, and ensuring seamless access to cutting-edge products. You will lead cross-functional teams, monitor evolving market trends, and contribute to strategic growth initiatives—all with a focus on ethical conduct and commercial success.

Required Skills:

• Proven experience in key account management within the healthcare or medical sectors
• Strong understanding of private medical insurance and healthcare frameworks
• Exceptional relationship-building and stakeholder engagement skills
• Commercial acumen with the ability to identify and capitalize on market opportunities
• Entrepreneurial mindset with proactive problem-solving abilities
• Ethical conduct and professionalism in all interactions

Nice to Have Skills:

• Background in neuroscience or medical sciences
• Experience working within the Alzheimer’s care or neurodegenerative disease markets
• Knowledge of healthcare regulations and compliance standards
• Previous experience in business development or strategic partnerships

Preferred Education and Experience:

• Bachelor’s degree in Life Sciences, Business, Healthcare, or related field (Master’s preferred)
• Minimum of 3-5 years’ experience in B2B healthcare sales, management, or business development within the UK/ROI region

Other Requirements:

• Ability to work remotely with occasional visits to the office as needed
• Availability to start ASAP
• Commitment to a 12-month full-time contract (37.5 hours/week)
• Candidates must be eligible to work within the UK/ROI

If you’re driven by innovation, possess the strategic mindset to grow a sector, and are ready to make a meaningful impact in neuroscience healthcare, we invite you to apply now and take the next step in your professional journey.
]]> Thu, 05 Mar 2026 00:00:00 EST 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 ]]> Thu, 05 Mar 2026 00:00:00 EST 0   Duties:
A shift: Schedule 5:00am to 1:00pm

 

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
]]> Thu, 05 Mar 2026 00:00:00 EST 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.]]> Thu, 05 Mar 2026 00:00:00 EST 1 Requirements

• MD or DO degree required from a U.S. accredited Medical School. 
• Active Board Certification
• Current and Active license to practice medicine in the U.S.
• Eight or more years of healthcare experience in a U.S. community practice setting targeting chronic disease management.
• Minimum two years of experience FDA clinical research as a Principal or Sub-Investigator. Inclusion of experience as a PI on GLP-1 studies that were at least a 12 month study.

SUMMARY:
Combines oversight of clinical trials with strategic medical leadership. Will lead clinical research programs as an Investigator across multiple therapeutic areas and serve as a primary medical authority for studies/trials. Will serve as a key medical and scientific leader, oversee protocol execution, ensure regulatory compliance, foster strong relationships with key stakeholders, and contribute to the growth of the organization through local community partnerships to support enrollment goals. Will provide mentorship to junior investigators, collaborate closely with operational leaders to optimize site performance, and participate in high-level strategy discussions that guide the future direction of the research center.

ESSENTIAL DUTIES:

• Serve as Principal Investigator
• Responsible for the conduct of clinical trials as per GCP/HSP guidelines to ensure participant safety, data integrity and responsibility for study staff.
• Collaborate with leadership to identify opportunities for new research programs, therapeutic areas, and strategic partnerships.
• Identify, develop and maintain partnerships with local community physicians/practices, organizations and community entities to support recruitment efforts, and expansion of therapeutic area.
• Maintain knowledge and clinical expertise in relevant therapeutic areas through ongoing professional development and conference participation.
• Provide thorough review of protocol and other study materials
• Determine clinical and practical “fit” for our practice partner sites by assessing study complexity, logistics, etc.
• Collaborate with Feasibility and Operations to determine which studies are appropriate for which sites/investigators.
• Collaborate with site operations, data management, and regulatory teams to ensure high-quality trial execution and patient safety.
• Provide therapeutic and protocol specific training and supporting material for project teams and local investigators as indicated, and for internal operation’s needs.
• Prepare risk assessments to determine potential pitfalls and issues that may occur during studies.
• Participate in the development and medical review of recruitment and enrollment strategies and material.
• Serve as a senior medical expert for ongoing trials, providing oversight on safety data, eligibility, and protocol adherence.
• Provide medical and scientific knowledge on products and therapeutic areas to inform future growth.
• Follow ethical and professional codes of conduct.
• Interact with outside medical experts as required.
• Adhere to the study plan by ensuring that all approvals are in place, vendors are qualified.
• Provide input and participate in technology and other strategic committees as appropriate.
• Comply with Company, Clinic, and Sponsor policies, standard operating procedures (SOPs), GCP guidelines, and documents according to ALCOA.
• Perform other duties as required and/or assigned.

 ]]> Thu, 05 Mar 2026 00:00:00 EST 0 Target PR Range: 79-89/hr
*Depending on experience

Overview
Join our International Customer Excellence PMO group supporting high-impact global business transformation, strategic programs, and product launches within a matrixed pharmaceutical environment. We’re seeking contractors who thrive in dynamic settings, partner well across regions and functions, and help drive operational excellence aligned with organizational growth.

Key Responsibilities:
• Execute PMO activities to enable aligned project delivery across multiple functions, regions, and affiliates
• Support and maintain industry-standard PMO processes, tools, and reporting methodologies to ensure consistency, governance, and transparency
• Collaborate with international commercial and marketing teams to facilitate smooth communication, touchpoints, and delivery of key initiatives
• Assist senior PMO leads and project managers in risk management, resource planning, and performance tracking for initiatives spanning business transformation, strategy, and launches
• Prepare project status reports, summaries, and presentations for stakeholders and sponsors
• Help coordinate cross-functional meetings and workshops (e.g., town halls, council sessions), ensuring logistical and content alignment

Skills, Experience, Education:
• Bachelor’s degree required
• Minimum 3 years’ experience managing matrixed, cross-functional, or global projects/programs (business transformation, strategic initiatives, product launch, etc.)
• Strong written and verbal communication skills; English fluency required
• Ability to engage with diverse stakeholders and teams in a global environment
• Familiarity with PMO methodologies, tools, and frameworks (specific certifications/tools TBD)
• Pharmaceutical industry exposure a plus but not required

Preferred:
• Project management certifications advantageous
• Direct experience supporting international initiatives or teams
• Experience preparing project reporting for senior management
]]> Thu, 05 Mar 2026 00:00:00 EST 1
The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD for assigned investigational and/or marketed product(s).  The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. Demonstrated ability to assimilate clinical data, and through its analyses/review be able to make crisp assessments and be able to communicate this effectively both verbally and in writing plays a critical capability in this job. The successful candidate will have demonstrated successful mastery of the above responsibilities in their work.  Accountability and a sense of urgency in leading/managing projects is a key success factor for this role.  
Position will report to the Senior Medical Director of DSPV  
Duties and Responsibilities:

•    Serve as key analytic and safety support lead in close collaboration with the product safety physician for the assigned product(s)
•    Responsible to analyze potential safety issues, including signal detection, signal evaluation and signal management. This includes coordination and documentation of all signal review activities.
•    Contribute to signaling and data mining activities utilizing internal and external sources of data 
•    Coordinate with Safety physician to lead Safety Committee meeting preparation and documenting of meeting minutes
•    Performing sponsor review of serious adverse events outsourced to our PV vendor
•    Responsible for safety review of protocol and CRFs, safety content of IB, ICF, and other documents to appropriately support Clinical study activities. 
•    Lead and author aggregate safety reports (e.g., DSUR/PSUR/PADER) in collaboration with key stakeholders and vendor. 
•    Coordinate ad hoc safety query or health hazard evaluation response plan for analysis in conjunction with the safety physician, Biostatistics and others as needed, including performing analysis and drafting of query responses for review and finalization.   
•    Key safety representation in Integrated Safety Summary reviews, Clinical study reports which may include narrative generation, review and approval for filing related activities.  
•    Keeping updated on relevant regulations associated with the above activities.  Contributes to initiatives for process improvement and cross-product process consistency.
•    Other tasks as assigned or required


Qualifications:   
•    Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist or similar role.
•    Demonstrated experience in analyzes, and interpretation of medical and scientific data and excellent verbal and written skills.
•    Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Biostatistics, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
•    Strong organizational, project management and leadership skills: Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. 
•    Applies clinical judgment to interpret case information.
•    Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
•    Strong  knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and  Argus Safety systems

Education:  
•    Advanced degree (PharmD, RN, MD, PhD, MPH, NP)]]> Thu, 05 Mar 2026 00:00:00 EST 1 The experienced Research Associate Scientist II, with a background in in vitro screening, will be part of our dynamic, fast-paced and interdisciplinary lead development team. Our mission is to advance novel RNAi therapeutic programs from target discovery through lead candidate selection. The Associate Scientist II will be technically skilled in molecular and/ or cell biology, and bring a rigorous, analytical approach to research.

This position is onsite and will be primarily located in Cambridge, MA. 

Key Responsibilities
•Perform cell culture (iPSCs, primary cells, immortalized cell lines) to support the research needs of the group and high-throughput screening of siRNAs using qPCR and a variety of cell-based assays
•Execute day to day operations for RNASeq sample preparation, including: library preparation, QC and sequencing. Maintain sample tracking & records.
•Conduct assays that support in vivo studies (e.g. qPCR, ELISA) for the quantitative analysis of biomarkers or siRNA activity  
•Support lab maintenance including equipment operation & maintenance, reagent inventory and reagent preparation
•Troubleshoot technical problems and participate in the continuing development and optimization of existing and new protocols.
•Utilize instrumentation and robotics to aid in high throughput (384-well) screening.
•Adapts well to the changing platform needs, in workflow, projects and other tasks as required by the platform.

Qualifications
• A BS in a biological science with at least 2 years of hands-on laboratory experience in cell or molecular biology are required 
•Experience in cell culture and purification/quantification of nucleic acids/protein, including qPCR
•Experience with NGS workflow is desired
•Experienced with laboratory automation including liquid handling systems such as Perkin Elmer JANUS, Beckman i7  or other systems.
•The candidate should be intensely detail oriented, highly motivated, capable of managing multiple projects simultaneously, desire to drive innovation, and willingness to learn
•We particularly seek someone who is detail oriented and who will flourish in a goal-driven team environment under tight deadlines.
•Excellent interpersonal skills with the ability to work well with others in a dynamic and highly collaborative environment.

Pay ranges between $38-41/hr based on experience ]]> Thu, 05 Mar 2026 00:00:00 EST 1 Join Our Team as an Associate Buyer/Planner – Drive Strategic Sourcing and Supply Chain Excellence

Are you a motivated professional with a passion for procurement, sourcing, and supply chain management? We are seeking a talented Associate Buyer/Planner to play a pivotal role in optimizing our procurement strategies and supporting cross-functional teams. This is a dynamic opportunity to contribute to impactful projects, leverage your negotiation skills, and develop your career within a collaborative, forward-thinking environment.

What You’ll Need to Succeed:

• Strong knowledge of procurement processes, strategic sourcing, and supplier relationship management
• Excellent negotiation and interpersonal skills to establish and maintain supplier agreements
• Ability to analyze data, identify opportunities for cost reduction, and recommend process improvements
• Project management skills with the capability to coordinate multiple initiatives simultaneously
• Effective communication skills to influence stakeholders and work collaboratively across teams
• Familiarity with supply chain systems and technology integration
• Detail-oriented with strong organizational and problem-solving abilities

Nice to Have Skills:

• Experience working in a regulated environment or in the medical device/healthcare industry
• Knowledge of commodity and category management strategies
• Exposure to contract law or experience drafting and reviewing supplier agreements
• Advanced proficiency in supply chain management software or ERP systems
• Certified Professional in Supply Management (CPSM) or similar credentials

Preferred Education and Experience:

• Bachelor’s degree in Business Administration, Supply Chain Management, Economics, or a related field
• Minimum of 2-4 years of relevant procurement or supply chain experience
• Prior experience in project management is a plus

Other Requirements:

• Ability to work in an office-based setting 3-4 days per week

Take the next step in your professional journey by applying today! This is your chance to become a vital part of a mission-driven organization committed to innovation and excellence in healthcare procurement. Don't miss out—apply now and showcase your expertise as our next Associate Buyer/Planner!
]]> Thu, 05 Mar 2026 00:00:00 EST 1 The Technical Writer will be responsible for creating, reviewing, revising, and finalizing high-quality documentation and labeling for the companies products. This role serves as a key point of contact between project teams and the Technical Documentation Department, ensuring timely delivery of compliant documentation in alignment with project schedules and regulatory standards. The writer will also support departmental tools, processes, and corporate standards.

Key Responsibilities
Act as primary Technical Writer on cross-functional project teams, attending meetings, tracking schedules, and reporting updates to the Documentation Supervisor.
Develop, edit, and maintain clear, accurate, and compliant documentation and labeling for product design, manufacturing, testing, release, installation, and distribution.
Facilitate the documentation review and approval process, resolving resource or timeline conflicts as needed.
Serve as liaison between project leaders and the Technical Documentation Department, conducting formal meetings and ensuring clear communication.
Use desktop publishing tools and Adobe Creative Cloud to produce professional text and graphics.
Assist in maintaining translated documents, corporate standards, and certificate library management.
Ensure compliance with quality system regulations (FDA, ISO, IVDD, 21 CFR 11) and support internal/external audits.
Maintain and improve documentation tools, processes, and performance metrics.
Collaborate effectively with interdepartmental teams, vendors, and customers.
Perform other duties as assigned by management.

Qualifications/ Education
Required: Bachelor’s degree in a scientific discipline, business administration, or related technical field.

Equivalency: Equivalent combination of education and relevant experience may be substituted.

Experience
Required: 5+ years of direct documentation experience in medical device, software, pharmaceutical, or biotechnology industries.

Required: Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR 11).

Required: Experience working on multiple projects within cross-functional teams.

Preferred: Experience with international regulatory requirements.

Technical Skills & Tools
Required: Proficiency with Adobe Creative Cloud, desktop publishing tools, and online help authoring.

Required: Experience with SAP and Google Suite.

Preferred: Skills in illustration, graphics, and screen capture.

Required: Strong knowledge of word processors, spreadsheets, project management software, and electronic document management systems.

Soft Skills & Abilities
Excellent written and verbal communication skills.
Strong organizational, negotiation, and problem-solving abilities.
Ability to work independently, manage multiple priorities, and meet deadlines.
High attention to detail and commitment to quality.
Ability to present information clearly to diverse audiences.

Pay ranges between $24-28/hr based on experience ]]> Thu, 05 Mar 2026 00:00:00 EST 1
This position reports into Associate Director of TMF Operations (or above).  

This role maintains the company's TMFs ensuring they are current and inspection-ready for internal and external entities.   The right candidate will possess an understanding of clinical trial conduct, TMF structure (TMF Reference Model), eTMF systems, and best documentation practices. 

What will be your responsibilities?
we have a dedicated TMF Operations Team that supports the study team in managing TMF Activities.

• Responsible for managing clinical document quality/control/review, and the Trial Master Files (TMFs).
• Performs set up activities, and oversight of internal e/TMF applications
• Supports Clinical Operations Study Leaders in the QC and oversight of CROs’ e/TMF applications
• Functional lead for specified e/TMF platform with vendor(s)
• Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines
• Provide training to eTMF users and external parties (CROs)
• Partner with management and others to support functional and organizational initiatives, to drive new procedures and ideas, and to function as an advocate for processes and decisions
• Supports the development and review of standard operating procedures and work instructions related to clinical document management, as appropriate
• Contributes to maintenance of written instructions, SOPs, guidelines and plans as they relate to e/TMFs and document control
• Updates and maintains Naming and Filing Guide(s) for relevant e/TMF systems
• Work in collaboration with all applicable functional areas
• Work in collaboration with Clinical Operations Management to drive new procedures and processes within the department, as appropriate

What qualifications do we require?

• Bachelor’s degree or equivalent combination of education/experience in science or health- related field
• Minimum 5 years of e/TMF experience for a pharmaceutical, biotechnology company, or contract research organization
• Thorough knowledge of all sections of the TMF Reference Model (current & previous versions)
• Thorough knowledge of documents from various functional areas and their appropriate e/TMF filing requirements

• Thorough knowledge of International Council for Harmonization (ICH) Good Clinical Practice (GCP) as well as Good Documentation Practice (GDP) principles

What qualifications do we prefer?

• Experience with eTMF system or software to include but not limited to development of SOPs, user training manual, performing UATs and validations, etc.
• Thorough knowledge of electronic TMF application(s), for major non-proprietary system(s) and ability to prioritize related tasks based on project goals
• Experience working with multiple eTMF vendors and CRO partners.

What capabilities do you bring?

• Motivated self-starter who is capable of flourishing in a fast-paced small company environment. 
• Creative problem solver with excellent communication and public speaking skills. 
• Proficiency in developing and delivering educational materials, both written and oral
• Ability to engage in cross-functional interactions with internal and external staff
• Global trial experience
• Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. 

]]> Thu, 05 Mar 2026 00:00:00 EST 1
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.
• 5-7 years experience required.

Comments
Work Days will be Tuesday to Saturday. 0530am to 200pm]]> Thu, 05 Mar 2026 00:00:00 EST 1 POSITION OBJECTIVE:
This is a leadership position for statistical programming, leading projects with higher level of complexity/challenges/difficulties, and leading efforts to resolve complex statistical programming issues or problems. Provide technical leadership and oversight to project teams while performing hands on work with complex tasks as well as with quality control activities. Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc. Participate in developing and maintaining clinical trial data and statistical reporting standards. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers. May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.
The hands on work to be performed by the incumbent include those to be performed by Senior Statistical Programmers, i.e. develop and review SDTM and ADaM dataset specifications and related documentation; program and validate SDTM and ADaM datasets; program and validate statistical output tables, listings, and graphs (TLGs) for Clinical Study Reports (CSRs) and Integrated Summary of Safety/Efficacy (ISS and ISE); lead project teams to support product regulatory submission preparation; program complex database logical checks and data monitoring reports.
SUBORDINATE POSITIONS:
None
TOTAL NUMBER OF SUBORDINATES (DIRECT & INDIRECT):
N/A
JOB ACCOUNTABILITIES:

1. Leadership and Project Management:

1. Lead projects with higher level of complexity/challenges/difficulties, and lead efforts to resolve complex statistical programming issues or problems.
2. Lead assigned projects by applying project management skills and statistical programming techniques; achieve on-time delivery of deliverables with quality and earn client’s trust and repeat business.
3. May represent the Company in interactions with clients regarding statistical programming projects and relevant businesses, such as programming oversight, project cost estimates and proposal development, bid defense meetings, etc.
4. Under supervision, may represent the Company to interact with regulatory agencies regarding matters relating to the responsible projects/programs.
5. Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.

1. Statistical Programming:

1. Develop SDTM and ADaM dataset specifications for CSRs, ISS, and ISE following company’s or client’s Standard Operating Procedures (SOPs) and project-specific requirements. Perform quality control (QC) review of these documents prepared by others.
2. Program and validate SDTM and ADaM datasets following approved dataset specifications for CSRs, ISS, and ISE.
3. Perform CDISC standard compliant checks on SDTM and ADaM datasets. Generate, review, and resolve Pinnacle 21 validation issues. Perform additional QC checks on these deliverables using company Working Instruction (WI) checklists.
4. Perform overall quality/consistency review of statistical TLGs before delivering them to the internal team or the client.
5. Create SDTM and ADaM define.xml files and table of contents. Perform QC review of these files prepared by others.
6. Participate and/or lead programming teams in support of product regulatory submission related activities.
7. Perform quality review/assessment on regulatory submission programming documents, datasets, computer programs, etc.
8. Learn and maintain expertise in the use of the utilities and macros developed for Statistical Programmers. Develop new macros and utilities.

1. Supporting Clinical Data Acquisition and Cleaning:

1. Program and perform QC/validation of complex data integrity checks to ensure data quality and ongoing scientific data surveillance.

1. Complete job-required and project-specific training. Comply with applicable Everest and trial Sponsor’s Policies, SOPs, and WIs.
2. Document data and programming information in accordance with corporate SOPs and guidelines.
3. Archive clinical trial data (SDTM and ADaM datasets) and programming information in accordance with corporate archival SOPs and guidelines.
4. May lead programming efforts for assigned client clusters when required.

MAJOR DECISIONS WITHIN THE INCUMBENT’S AUTHORITY LEVEL:
The incumbent may make decisions in the following areas:

1. Decisions on time allocation to complete assigned projects.
2. Decisions or recommendations to project teams or staff members in generating complete, accurate and efficient programming deliverables.
3. Decisions on therapeutic area programming standards/conventions/procedures within assigned therapeutic areas as a lead programmer.
4. Decisions on client specific programming standards/conventions/procedures for assigned clients when required.
5. Schedule of training/education for professional development.

DECISIONS REFERRED TO THE NEXT LEVEL OF MANAGEMENT:
The incumbent may, in consultation with the direct manager and other relevant functional group leaders, make recommendations on the following decisions. However, the final decision/signing authority in each of the following areas will be with the corporate designated signing officers.

1. Priorities of projects.
2. Allocation of resources to projects.
3. Individual developmental plan.

LEVEL OF ACCOUNTABILITY:
Effective job performance can have a major impact on the effectiveness and efficiency of the statistical programming operation. Close mentoring and supervision for the assigned study team will greatly improve the productivity of the teams and the quality of their deliverables. The position will impact more than 5 trials being conducted at any given point in time.
KEY EQUIPMENT/SOFTWARE USED:

1. Microsoft Word, Excel, PowerPoint, Outlook.
2. SAS.
3. InForm, MediData Rave, DFdiscover.
4. Other software as may be required.

 ]]> Thu, 05 Mar 2026 00:00:00 EST 0 Pay range: 38-48/hr
*depending on experience

Purpose
The Med Reviewer has a key role within the designated Therapeutic Area. Working under the leadership of the Scientific Director, this leader supports the development and execution of the therapeutic area medical strategy, specifically as it pertains to the specific asset or indication by providing scientific, strategic, and operational input into core medical affairs activities including dissemination of clinical and scientific data, provider and payer educational initiatives and promotional material generation. This leader ensures tactical execution is relevant to the market– physicians, patients and payors. They will ensure accurate and compliant medical review of medical and promotional materials within relevant hematologic malignancies therapeutic areas (such as CLL, BPDCN, or others). They act as a liaison for congress planning and management, coordinate with vendors and teams, and organize debriefs and feedback sessions post-congress to capture learnings and optimize future events. Additionally, they may contribute to the creation of medical material resources and digital medical education, helping support organizational commercial and medical objectives.

Responsibilities
1. Conduct accurate and compliant medical review of medical and promotional materials, ensuring consistency with regulatory and scientific standards.
2. Perform reviews using platforms such as Veeva PromoMats and/or MedComms; utilize CRM knowledge when beneficial.
3. Rapidly learn and master new disease states, with particular emphasis on relevant hematologic malignancies therapeutic areas like CLL and BPDCN.
4. Clearly and concisely communicate rationales for review decisions to Commercial and Medical teams, fostering cross-functional collaboration.
5. Lead or support the creation, review, and approval process for medical and promotional materials, including digital deployment.
6. Ensure all materials meet internal legal, regulatory, and medical standards with high scientific integrity.
7. Collaborate with Medical Affairs, Marketing, and Field Teams to align messaging and ensure assets reflect the latest clinical data.
8. Take ownership of end-to-end congress planning and management, including:
o Coordinating logistics (booth content, registration, hotel/travel arrangements, EE meeting logistics, etc.)
o Acting as liaison between vendors and internal teams
o Managing timelines, feedback sessions, and budget tracking
o Overseeing the development, review, and delivery of booth materials, ensuring compliance and timely execution
o Organizing post-congress debriefs and feedback sessions
9. With oversight, contribute to the development of the therapeutic area strategy.
10. Contribute to all launch readiness materials


Qualifications - External
1. Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.
2. 3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of relevant therapeutic area required.
3. Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
4. Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
5. Good understanding of Medical Affairs principles, study design and publications.
6. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
7. Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
8. Ability to interact externally and internally to support global business strategy. Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills (oral and written).
9. Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
10. Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships.

*CO/NYC candidates might not be considered
]]> Thu, 05 Mar 2026 00:00:00 EST 1 The Opportunity:  Biospecimen Management Specialist

Playing a critical role as a Biospecimen Management Specialist within Translational Medicine function, the position will be providing sample management support in, developing scope of work for query resolution and sample management, and maintaining effective working relationships with cross-functional teams for clinical trials.

• 
  Provide expertise in sample tracking for clinical trials.
  
• 
  Provide sample management support for clinical trials.
  
• 
  Provide daily operational support for sample shipment while ensuring end-to-end chain of custody.
  
• 
  Work independently on completing all sample related tasks for timely delivery of results.
  

• 
  Work in close collaboration with Translation Medicine Biospecimen Operations Leads and Clinical Operations team.
  
• 
  Provide biomarker sample management plan to key stakeholders.
  
• 
  Perform day-to-day operational management of CROs to ensure timely delivery with a high standard of quality.
  
• 
  Perform sample query resolution and sample management in a timely manner
  
• 
   Assist in sample reconciliation between clinical sites and  central labs.
  
• 
  Provide sample and assay status updates to cross-functional teams.
  
• 
  Manage documentation and tracking of samples in the Company’s systems.
  

Required Skills, Experience and Education:

• 
  Life sciences degree (BS or MS) in scientific, medical, healthcare, or related discipline.
  
• 
  2+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory.
  
• 
  A knowledge of RAVE Electronic Data Capture System is highly desirable.
  
• 
  Excellent scientific and business communication skills, strong interpersonal/collaboration skills, and planning skills.
  
• 
  Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
  
• 
  Ability to multi-task and thrive in a fast-paced innovative environment.
  
• 
  A great teammate, who listens effectively and invites response and discussion.
  
• 
  Commitment to Core Values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.
  

Preferred Skills:

• 
  Should be proficient in Microsoft Excel, Microsoft PowerPoint applications.
  
• 
  Experience in using Project Management tools is desirable.
  
• 
  Prior experience in clinical biomarker operation and/or sample management in phase III clinical trials is highly desirable.
  

]]> Thu, 05 Mar 2026 00:00:00 EST 0 Candidate Details
2+ to 5 years experience
Minimum Education - Associate's Degree
Willingness to Travel - Occasionally
Ideal Candidate
Using hand tools and test equipment, the individual will perform maintenance on both electronic and mechanical equipment, such as industrial controls, computers, and servo-mechanisms, following blueprints and manufacturer’s specifications. Performs duties within cGMPs for Medical Devices, maintaining change control, notifying QA/RA and engineering where necessary and makes adjustments only within documented and validated limits. Ensures compliance with quality systems, policies, procedures and best practices, and all local, state, federal and safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English.
Duties/Responsibilities:     

• Perform troubleshooting, diagnosis causes and repair equipment.
• Perform preventative maintenance (PM's) on equipment.
• Maintain parts inventory.
• Support engineering projects-ordering and installation of new equipment, new equipment IQ's.
• Continuous Improvement projects to reduce expenses, improve reliability, and reduce waste.
• Test electronic circuits to locate defects and understand the use of oscilloscopes, signal generators, amp meters, and voltmeters. 
• Install, modify and understand control panel wiring. Work closely with the Controls group to understand and modify PLC programs and maintain PLC ladder logic programs.
• Train operators and assist with machine set-ups/operation as required.
• Work with central crib to maintain an inventory of spare parts, both fabricated and commercial.   Perform troubleshooting and repair of pneumatic and mechanical systems.
• Propose design changes and review with engineer to upgrade equipment, eliminate re-occurring problems, improve product quality, reduce costs, etc. 
• Duties may require correction of problems during off shifts on a call-up basis. Work closely with tool room to make timely repairs.   Work schedules may fluctuate due to product and process start up or machine issues, as well as training of new associates on the off shifts.  Must be flexible and willing to work overtime when needed.    
• Other duties as required to support the needs of the business

Education:

• High School Diploma or GED required
• Associates Degree in a technical field preferred
• In Lieu of Associates Degree, two years technical experience required

Knowledge, Skills and Abilities:

• Thorough understanding of hydraulic, electric, mechanical and pneumatic systems - Proficient
• Ability to read blueprints and schematics - Proficient
• computer skills (SAP, Excel, Word preferred) - Basic
• Ability to maintain accurate records - Proficient

Relocation assistance available ]]> Thu, 05 Mar 2026 00:00:00 EST 1 The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
1. Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.
2. Proven problem-solving skills.
3. Makes measurable improvements to processes and procedures.
4. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.
5. Acts as a team member representing Quality on new product development and sustaining engineering projects.
6. Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.
7. Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training).
8. May perform other duties as required.

Education and Experience:
Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and relevant experience.

Knowledge and Skills:
• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
• Applied knowledge of Corporate and/or Unit requirement.
• Able to contribute to the completion of specific programs and projects.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Able to revise policies and procedures
• Able to make presentations
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:
o Acceptance sampling theory and application
o Statistical process control methods and application
o Measurement system/test method knowledge and analysis
o Quality planning
o Failure analysis investigation
o Design of Experiments
o Process mapping and value stream analysis
o Hypothesis testing
o Descriptive statistics
o Process capability analysis
o Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
o Risk Management
o Supplier quality management
o Auditing
o Design/development tools
o Process validation
o Software validation
]]> Thu, 05 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 *Depending on experience

Job Description:
The Medical Affairs Operations Manager partners with key partners such as Disease Area and Regional Medical teams to drive operational excellence across annual medical planning, launch readiness, budgeting, and delivery of key Medical Affairs milestones. The role governs the Medical Affairs Strategy Team (MAST) forums—owning membership, charter, cadence, and outputs—and manages the business process calendar to ensure insight generation, evidence generation planning, publication planning, and medical strategy documents are delivered on time, in scope, and with high quality in a global, matrixed environment.

Key Responsibilities:
1) Governance & cross functional orchestration
• Coordinate and lead Medical Affairs Strategy Team (MAST) forums for assigned Disease Area(s): maintain current membership, charter, standing agenda, and ensure meetings occur at the defined cadence with documented decisions and actions.
• Establish and maintain a RACI and governance rhythm that enables rapid issue escalation, risk/decision tracking, and cross functional alignment (Medical, Clinical, Publications, HEOR, Commercial, Regions, and enabling functions).
2) Annual planning, launch readiness & process ownership
• Implement and maintain global operational templates (e.g., annual medical plans, launch playbooks, budget worksheets) within assigned Disease Area(s) (DAs); ensure consistent usage and version control.
• Own the Medical Affairs business process calendar to drive on time inputs/outputs across insights? evidence generation planning? publication planning? medical strategy documents; coordinate dependencies with global/regional partners.
3) Budget, timeline & performance management
• Partner with finance and DA leads to plan, track, and reconcile budgets; surface variances, risks, and opportunities; maintain auditable documentation.
• Build and maintain milestone plans/Gantt schedules; monitor critical path, mitigate risks, and publish status dashboards and executive summaries.
4) Grants & Investigator Initiated Studies (IIS) support
• Partner with Grants/IIS operations to coordinate intake, review calendars, and milestone tracking; ensure alignment with medical strategy and governance requirements.
• Facilitate operational readiness (e.g., SOP adherence, documentation completeness, and cross functional handoffs) for grants/IIS processes.
5) Quality, compliance & inspection readiness
• Ensure processes and deliverables meet internal SOPs and external standards; maintain audit ready records for plans, forums, budgets, and decisions.
• Drive continuous improvement in templates, SOPs, and ways of working; capture lessons learned and standardize best practices.
6) Tools, reporting & communication
• Build lightweight dashboards and trackers (e.g., Smartsheet/MS Project/Gantt, budget trackers, KPI scorecards) to enable transparent decision making.
• Synthesize updates for senior Medical leadership—highlighting progress, risks, decisions needed, and mitigation plans.

Required Qualifications:
• Bachelor’s degree required. Advanced degree and/or PMP or equivalent project management certification desirable.
• 10+ years of relevant experience in pharma/biotech within Medical Affairs operations, clinical/medical program management, or closely related functions in a global, matrixed setting.
• Proven ability to lead cross functional, complex initiatives without direct authority; strong stakeholder management across global/regional partners.
• Demonstrated excellence in planning, governance, risk management, budgeting, and operational problem solving.
• Proficiency with Smartsheet and/or MS Project (Gantt), portfolio dashboards, and budget management tools; strong Excel/PowerPoint skills.
• Exceptional written and verbal communication; comfort presenting to senior leadership.

Preferred / Nice to Have Qualifications:
• Familiarity with Medical Affairs planning cycles (insights, medical strategies, launch planning, metrics/KPIs).
• Process design/continuous improvement (templates, SOPs, training).
• Grants & IIS operations exposure (governance cadence, documentation, milestone tracking).
• Experience with publication planning governance and evidence generation planning cycles.]]> Thu, 05 Mar 2026 00:00:00 EST 1 Position Title: QA Contractor (Specialist IV, Audits and Supplier Quality)     
Location: (Onsite) Houston, TX
Department: Quality Assurance


Responsibilities

• Plan, schedule, lead, and execute internal and external (supplier/vendor) quality system audits according to established procedures and regulatory requirements.
• Maintain and improve audit program, including audit schedules, checklists, and reporting.
• Ensure audit readiness for regulatory inspections and host regulatory inspections as required.
• Develop risk-based audit plans and establish audit schedules in alignment with business priorities.
• Review, approve, and track non-conformances, observations, and Corrective and Preventive Actions (CAPA) resulting from audits to ensure timely and effective closure.
• Prepare comprehensive audit reports detailing findings, observations, and compliance status. Present audit results and key quality metrics to senior management.
• Lead the initial qualification and ongoing re-qualification of critical suppliers, including system assessments, on-site audits, and technical reviews to ensure robust Quality Management Systems (QMS).
• Plan, execute, and report on supplier and contractor audits globally, including CMOs, CROs, raw material providers, and service suppliers.
• Draft, negotiate, review, and ensure the execution and maintenance of comprehensive Supplier Quality Agreements (SQAs) with key suppliers, outlining mutual quality responsibilities to ensure alignment with regulatory expectations and company standards.
• Develop, monitor, and analyze key Supplier Quality Performance Indicators (KPIs) and metrics (e.g., defect rates, on-time delivery, CAPA effectiveness). Drive performance reviews with underperforming suppliers.
• Act as a final escalation point and lead cross-functional teams (including Procurement, Engineering, and Manufacturing) in complex root cause analysis (RCA) and implementation of Corrective and Preventive Actions (SCARs/CAPAs) for supplier-related quality issues to evaluate and mitigate supplier risks.
• Review and approve supplier-initiated change notifications, assessing their potential impact on product quality and compliance, and ensuring necessary internal actions are taken.
• Identify, develop, and implement strategies for continuous improvement within the SQM and Audit processes to enhance efficiency, reduce risk, and improve overall product quality.
• Conduct and maintain supplier risk assessments (e.g., criticality, quality history) to focus resources on the highest-risk areas of the supply chain.
• Triage supplier change notifications, assess material/specification changes, and initiate or coordinate change controls as required. 
• Mentor and train junior quality specialists and cross-functional partners on audit techniques, supplier quality requirements, and use of quality tools (e.g., RCA, FMEA).
• Author, review, and approve departmental Standard Operating Procedures (SOPs) and work instructions related to supplier quality and auditing.
• Other duties as assigned.

Qualifications/Skills

• Bachelor’s degree in Life Sciences, Engineering, or related discipline required; advanced degree preferred.
• 8+ years of progressive experience in Quality Assurance, supplier quality management, or GMP auditing within the pharmaceutical, biotechnology, or medical device industry.
• Understanding of Cell and Gene Therapies. 
• Certified Quality Auditor (CQA), ISO Lead Auditor, or equivalent certification strongly preferred.
• Demonstrated experience hosting and supporting FDA, EMA, MHRA, or other regulatory inspections.
• Experience with Health Authority regulations (US FDA, EMA, ISO 9001, ISO 13485, etc.) preferred.
• Understanding of GxPs.
• Advanced understanding of supplier qualification, auditing principles, and risk management tools.
• Knowledge of local and global regulations. 
• Excellent verbal and written communication skills. 
• Excellent interpersonal and customer service skills. 
• Excellent organizational skills and attention to detail. 
• Excellent time management skills with a proven ability to meet deadlines. 
• Strong analytical and problem-solving skills. 
• Proficient with Microsoft Office Suite or related software. 

]]> Thu, 05 Mar 2026 00:00:00 EST 0 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]]> Thu, 05 Mar 2026 00:00:00 EST 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, 05 Mar 2026 00:00:00 EST 1 Pay range: 47-57/hr
*depending on experience

We are seeking a contract Medical Reviewer to support our international Botox Therapeutic Neurotoxin team. The ideal candidate will be responsible for the medical review of clinical and scientific data related to the use of Botox for various therapeutic indications.

Key responsibilities include ensuring the accuracy and compliance of content with regulatory and company standards, providing expert medical input on clinical documents and safety information, and collaborating with cross-functional teams globally.

Qualifications:
The candidate should have a medical degree (MD or equivalent), clinical experience in neurology, physical medicine, or related fields, and a solid understanding of regulatory requirements for therapeutic neurotoxins. Experience with Botox or neurotoxin therapies is strongly preferred. Excellent communication and detail-orientation are essential.
Must have experience as a Reviewer OUS, understanding regulatory complexities of international markets.

*CO/NYC candidates might not be considered
]]> Thu, 05 Mar 2026 00:00:00 EST 1 Purpose and Scope
The Precision Engagement Project Manager plays a criticalrole in enabling the operational excellence of the Omnichannel Experience team.This position focuses on supporting the Precision Engagement Lead throughexpert-level management of project management tools—primarily Azure DevOps(ADO)—and ensuring consistent, efficient execution of AI/ML-driven omnichannelinitiatives.
This role ensures workstreams are properly structured,tracked, and delivered using Agile methodologies and enterprise PM tools,enabling stronger cross-functional coordination across OC Activation, DataScience, and Digital Excellence teams.
 

---

Responsibilities and Accountabilities
Project Management & ADO (Azure DevOps) Enablement

• Build, manage, and optimize ADO project structures, dashboards, sprints, and work item templates to support omnichannel program execution.
• Maintain backlog hygiene, ensuring user stories, tasks, and acceptance criteria are consistently documented.
• Partner with Precision Engagement Lead to translate business needs into epics, features, and user stories.
• Provide ongoing ADO training, troubleshooting, and best-practice guidance for cross-functional partners.

Operational Excellence & Workflow Structuring

• Create and manage standardized PM frameworks (RACI, sprint cadences, scorecards, dependency trackers).
• Ensure Agile ceremonies are well-organized, including sprint planning, retrospectives, and daily stand-ups.
• Develop documentation, templates, and playbooks for omnichannel programs and AI-driven workflows.

Collaboration & Cross-Functional Alignment

• Work closely with Data Science, OC Activation, and Dx teams to ensure proper workflow integration.
• Support vendor onboarding processes and manage documentation for partners engaged in AI/ML and omnichannel delivery.
• Act as PM liaison to ensure timelines, deliverables, and interdependencies are clearly communicated.

Reporting & Analytics

• Create dashboards and reporting structures in ADO, Power BI, or Excel to track progress, risks, and performance.
• Consolidate sprint performance metrics and identify opportunities for operational improvement.
• Support tracking of AI-driven campaign deployment readiness.

Governance & Compliance

• Ensure project documentation aligns with the company's compliance and data governance standards.
• Maintain audit-ready records within ADO and PM tools.

 

---

Required Qualifications

• Bachelor’s degree in Business, Marketing, Digital Operations, IT, or related field.
• 3+ years of experience in project management, digital operations, or omnichannel execution.
• Hands-on experience with Azure DevOps, Jira, or similar PM tools.
• Strong understanding of Agile methodologies and workflow orchestration.
• Ability to document user stories, process flows, and operational frameworks.
• Excellent organizational and time-management skills.
• Strong problem-solving abilities and comfort working across cross-functional teams.
• Proficiency with Microsoft Office, Power BI, and digital collaboration tools.

 

---

Preferred Qualifications

• Experience supporting omnichannel marketing, marketing technologies, paid media, digital operations.
• Certifications such as Scrum Master (CSM), Product Owner (CSPO), or PMP.
• Experience working with Data Science teams or technical development workflows.
• Familiarity with Marketo, Salesforce MarketingCloud, or other marketing automation platforms.

]]> Thu, 05 Mar 2026 00:00:00 EST 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.

 ]]> Thu, 05 Mar 2026 00:00:00 EST 0 Job Overview
• Responds to unsolicited medical requests regarding products from HCPs, members of the public, and internal colleagues. Responses are provided in a timely manner using approved standard documents, up-to-date literature support and other resources
• Uses scientific and MI expertise to drive strategic initiatives and empower key stakeholders, HCPs, patients and other requestors with globally aligned resources that enable timely, informed decisions and improved patient outcomes
• Prepares global resources in collaboration with local affiliate teams (TA specialist team). Prepares local resources (affiliate MI specialist team). Vendors may be used
• Identifies, reports and records adverse events and product complaints in a timely manner in accordance with SOP. May be asked to provide medical review for promotional and/or medical materials

Responsibilities
Routine responsibilities may include the following
• Respond to unsolicited requests for medical and scientific information regarding products and documents in the request handling system (MiQ)
• Researches and collaborates with cross functional colleagues to provide response to complex requests. TA specialist responds to complex requests from affiliate MI and internal colleagues
• Create, update, and participate in review and quality check of MI response documents in accordance with local laws and regulations
• MI specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs, development, regulatory, global patient safety and operations, commercial, to manage global response topics and content
• MI specialist prepares data on file to support response documents and complex requests
• Maintain document repository with regular/routine review of approved documents for new data from regulatory updates, scientific conferences, up-to-date literature searches, proactive literature surveillance, or newly published materials
• Understand the needs and preferences of internal and external partners and customers
• Review and provide analysis of MI databases for trends, customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
• May oversee and/or evaluate external consultant writers
• MI specialist provides process and product training to colleagues and vendors as required
• Support departmental strategic initiatives to address major activities within TA (product launches, labelling updates, patient engagement etc.)
• Identify, report and record adverse events and product complaints in a timely manner in accordance with SOP
• Participate in MI activities and projects in line with global and regional strategic MI plans
• Works under supervision of manager or colleague

Knowledge and Skills
• Excellent written, verbal and interpersonal communication skills, and the ability to work well in multidisciplinary teams, across geographies
• Ability to create and provide clear communication of scientific data for different audiences, including members of the public
• Knowledge and understanding of marketed and investigational products
• Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment, with understanding of regional or country regulations related to the provision of MI services
• Ability to provide analysis and evaluate clinical, biomedical and scientific data
• Ability to develop and maintain good working relationships with departmental and cross-functional colleagues
• Understanding of internal and external stakeholder needs and priorities
• Serve as an advocate for MI affiliate or Global MI
• Demonstrates core values and Leadership Commitments
• Has a strong attention to detail, excellent project management and problem-solving skills, and ability to think creatively
• Good organizational and work planning skills and ability to manage multiple projects in a fast-paced environment
• Awareness of digital solutions for communicating with healthcare providers and patients
• Previous experience with problem-solving and project management preferred

Education and Experience
• Pharmacy, Nursing or Medical/ Life Sciences degree/advanced degree or equivalent (PharmD preferred)
• Experience in MI or working in a healthcare environment preferred.
• Experience in the pharmaceutical industry or a MI vendor preferred.
• Experience in Cell Therapy, Hematology or Oncology preferred

Pay ranges between 50-55/hr based on experience ]]> Thu, 05 Mar 2026 00:00:00 EST 1

We’re looking for an experienced Multiskilled Maintenance Engineer to join a fast?paced manufacturing environment, supporting high?speed processing and packaging equipment. You’ll play a key role in keeping production running smoothly through proactive maintenance, rapid fault?finding, and continuous improvement.

The role:
You’ll carry out planned and reactive maintenance on a range of electro?mechanical machinery, troubleshoot breakdowns to minimise downtime, and work closely with production teams to ensure lines operate at peak efficiency. Keeping documentation and CMMS records up to date, supporting improvement projects, and maintaining a strong safety focus are all essential parts of the position.

What we’re looking for:
A Time?Served Apprentice or qualified engineer (ONC/HNC/NVQ Level 3) with solid mechanical and electrical skills. Experience with processing/packaging machinery, PLC fault?finding, drives, and circuits from 415V downwards is highly beneficial. You’ll be comfortable working in a fast?paced manufacturing setting, adaptable to change, and confident analysing and resolving technical issues. Familiarity with systems such as SAP, Maximo, and Microsoft Office is an advantage.
]]> Thu, 05 Mar 2026 00:00:00 EST 1 Functions independently as a project lead or lead statistician to deliver the project tasks/responsibilities. Performs project management functions relating to the administrative and scientific activities of specific project work and team members. Oversees statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians.
Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.

Essential Functions: • Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Follows departmental procedures for statistical analyses and programming work.
• Work independently as a project lead or as lead statistician to deliver on lead tasks/responsibilities across large and complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed.
• Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Provides randomization schemes and appropriate documentation.
• Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis.
• Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints.
• Prepares reports, manuscripts, and other documents. Contributes statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
• Monitors project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicates with sponsors concerning project work scope and budgetary changes after reviewing with management.
• Mentors members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning.
• Provides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or
policies, assists with newsletter, helps in department libraries, or trains new hires).
• Acts as the representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.
Education and Experience: • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’).
• Master's degree in statistics, biostatistics, mathematics or related field
• 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: • Strong SAS® programming skills (Proficient in BASE, STAT, MACRO and GRAPH) and understanding of database structures
• Capable of directing and promoting teamwork in a multi-disciplinary team setting
• Strong understanding of statistical principles and strong statistical skills
• Solid project management skills, as shown through management of multiple projects
• Demonstrated initiative and motivation
• Strong written and verbal communications skills, including proficiency in the English language
• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Strong interpersonal skills and positive attitude to work effectively in a team environment and act as a liaison with other departments



Pay Rate Range: $55-77/hr depending on experience  ]]> Thu, 05 Mar 2026 00:00:00 EST 1 Responsible for the coordination and administrative support of key tasks critical to the successful execution of the Facilities & Site Services (F&SS) charter by: Working directly with all internal functional areas located on the Tucson campus to coordinate equipment maintenance. Interacting with external providers to assist in the coordination, execution & organization of maintenance services. Providing administrative support to Facilities & Site Services management staff.

Responsibilities
•Coordinate maintenance and operation of the software used for equipment work orders and.
•Coordinate the processing and closure of calibration and maintenance work orders.
•Collect, input and monitor equipment calibration data required to comply with FDA, ISO and other relevant agency requirements.
•Coordinate and process purchase requests, purchase orders and payment of Facilities & Site Services
invoices with external vendors.
•Support external contractor pre-qualification process and work with internal project leads to promote compliance.
•Assist with the compilation, organization and monitoring of key maintenance metrics / data.
•Possess a familiarity with key equipment maintenance processes and projects to be able to provide direction in response to inquiries.
•Utilize current operating systems (e.g. BM Regulatory Asset Manager, EtQ, SAP, Microsoft Windows, etc.) for execution of tasks and communications.
•Establish and maintain files of highly confidential data and importance
• Perform other duties as required or assigned

Knowledge, Skill or Ability
Excellent time management, planning, organization and problem solving skills,
Must be able to coordinate and support cross functional teams and multiple projects in a fast paced,
dynamic environment…able to multi-task and prioritize.
Must be people-oriented and a team player with strong interpersonal, written and verbal communication skills.
Strong customer service skills, proactive and highly motivated.
Strong process orientation and attention to detail.
Strong data entry skills and familiarity with personal computers, word processing, spreadsheet, operating, presentation and scheduling/project management software.
Able to manage and meet deadlines.
Able to read, understand, and prepare standard business communications.

EXPERIENCE & EDUCATION
--High School Diploma (or Associate's Degree)
--2-4 years experience in project coordination, customer service, functional administration support, equipment maintenance and support, or equivalent

Pay ranges between 20-24.50/hr based on experience 
]]> Thu, 05 Mar 2026 00:00:00 EST 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, 05 Mar 2026 00:00:00 EST 1

Full time l 12 months contract

A major capital project in the life sciences sector is seeking an experienced Process Safety Specialist to support safe commissioning and execution across a complex and highly regulated environment. You will play a central role in risk analysis, process safety leadership and incident management while working closely with system owners and commissioning teams.
The Role
You will take a leading role in process safety activities and drive clarity, structure and safe work practices throughout the project.

Key responsibilities include

• Leading risk analysis for high risk activities and working with system owners to establish clear method statements
• Facilitating structured risk workshops including HAZID sessions and HAZOP sessions
• Acting as safety lead on system walks and pre startup safety reviews during commissioning
• Conducting incident investigations and supporting continuous improvement
• Contributing to a strong safety culture through clear communication and structured facilitation

What You Bring

• Five plus years of experience in technical or process safety within highly regulated and high risk industries such as life sciences energy or oil and gas
• Strong understanding of barrier management and preferably bow tie methodology
• Background covering operations design construction and commissioning on large scale projects
• Experience as a lead incident investigator
• A naturally structured communicator and facilitator with strong stakeholder skills

]]> Thu, 05 Mar 2026 00:00:00 EST 1
Executive Assistant to VP Global Supply Chain

We are seeking an exceptional Executive Assistant to support the VP of Global Supply Chain. This opportunity requires a polished professional who thrives in a fast-paced, dynamic environment and is motivated by the opportunity to impact across the organization.
More than an administrative partner, the Executive Assistant will serve as a trusted extension of the VP of Global Supply Chain. anticipating needs, taking initiative, and creating leverage so the VP Global Supply Chain can focus on the most critical priorities. In addition, this role provides the opportunity to influence and support other administrative staff, encouraging teamwork, fostering collaboration and building a collegial, collaborative environment. This position is highly cross functional and global in scope, requiring the ability to navigate multiple time zones, cultures and priorities.

What You’ll Do
• Serve as the right-hand; anticipating needs, taking initiative, and creating leverage so the VP Global Supply Chain can focus on critical priorities.
• Orchestrate complex scheduling, travel, communications, and team preparation with discretion, accuracy, and efficiency.
• Serve as a trusted liaison for the VP Global Supply Chain with senior leaders and external partners – ensuring seamless preparation and execution of meetings while representing the company with professionalism, poise and executive presence.
• Partner in building and sustaining company culture by supporting offsites, events, and initiatives that strengthen engagement across BioMarin's global sites.
• Support the VP Global Supply Chain and fellow administrative professionals in leveraging digital tools—including emerging technologies like AI—to drive efficiency and unlock new ways of working.
• Draft, review, and refine communications, presentations, and reports with clarity, accuracy, and professional polish.


What You Bring
• 10+ years of experience supporting senior executives in complex, global, or high-growth organizations.
• A reputation for being proactive, kind, and highly attuned to anticipating the needs of executives.
• Demonstrated success managing interactions with senior leadership teams.
• Exceptional organizational skills with the ability to manage multiple, shifting priorities in high-pressure environments.
• Superior written and verbal communication skills, with executive-level polish.
• Strong problem-solving ability and creativity in approaching challenges.
• Experience mentoring or leading administrative professionals.
• Proven fluency with modern digital tools and platforms; comfort guiding others in navigating emerging technologies.
Work Hours/Location: This is a full time, hybrid onsite role based at HQ in San Rafael, CA. You will typically work onsite most days alongside other Executive Assistants.

Why Join Us?
This is a unique opportunity to directly support the VP Global Supply Chain of a global biotechnology leader, helping drive organizational impact and supporting the mission to bring life-changing therapies to patients around the world. In this role, you will contribute to the growth and culture of the company, and gain exposure to strategic decision-making at the highest levels. You’ll collaborate with talented colleagues worldwide and play a critical role in enabling the future of an innovative, mission-driven organization.

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, 05 Mar 2026 00:00:00 EST 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 ]]> 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 Pay range: 19-20/hr
*depending on experience

is looking for a Bottling Technician for our Form, Fill, and Finish Group. This role will be responsible for processing product formulations, dispensing antibody products, capping, labeling, kitting and completing batch records, and putting away Finished Good Inventory (FGI). This is a highly team oriented group which involves working closely with other core teams within the Bottling Department as well as other departments such as Planning, Receiving, Inventory Control, Custom Solution Team (CST), Packaging and Quality Control groups.

Skills: 
Assist in performing various bottling related tasks to include dispensing antibody solutions, capping and labeling of vials, tubes or bottles, and assembly of kits
Formulate products per approved Standard Operating Procedures (SOPs) and work instructions including multi-component cocktail formulations
Verify formulation worksheets to ensure that information such as concentrations, lot numbers etc. are correct
Put away finished goods products according to 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 machine, etc.)
Follow instructions for completion of job tasks
Adhere to correct procedures, policies and health/safety guidelines
Clean and maintain work area and all lab equipment and supplies
May perform data entry and production documentation completion tasks
Other projects or responsibilities as may be required.

Education:
>6 months of relevant experience in a laboratory and/or biotech manufacturing and/or filling/bottling/packaging working environment
Experience in pipetting or dispensing liquid products
Ability to perform simple math calculations]]> Thu, 05 Mar 2026 00:00:00 EST 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).

  ]]> Thu, 05 Mar 2026 00:00:00 EST 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  ]]> Thu, 05 Mar 2026 00:00:00 EST 1 Duties:
The Credit Manager is responsible for managing the company’s credit risk and collections processes to ensure timely payment, healthy cash flow, and minimized bad-debt exposure.
This role oversees customer credit evaluation, accounts receivable collections, dispute resolution, and related policies, while partnering closely with Sales, Finance, and Customer Service to support business growth.

Essential Duties:

• Implementing and reviewing the company’s credit and collection policies and procedures
• Managing and overseeing the collection of outstanding debts from clients and customers
• Communicating with customers regarding their accounts and any overdue payments
• Manage the end-to-end collections process to ensure timely payment of outstanding invoices
• Develop and execute collection strategies to reduce delinquency and improve Days Sales Outstanding (DSO)
• Oversee escalations for past-due accounts, including payment plans, account holds, and referrals to external collection agencies or legal counsel as needed
• Resolve billing issues, disputes, and short-payments in coordination with internal teams
• Resolving customer queries and disputes related to invoices
• Prepare regular reports for leadership on credit exposure, overdue accounts, and collection
• Negotiating repayment plans with customers when necessary
• Ensuring compliance with local, state, and federal laws regarding collections and credit practices
• Continuously improve credit and collections processes, tools, and controls
• Implement best practices and automation to enhance efficiency and scalability
• Lead, mentor, and develop credit and collections team
• Other job duties as assigned

Skills:

Experience:

• Bachelor’s degree in Finance, Accounting, Business, or a related field (or equivalent experience)
• [5+] years of experience in credit, collections, or accounts receivable, with at least [2+] years in a supervisory or managerial role
• Strong understanding of credit analysis, collections strategies, and AR processes
• Proven ability to reduce delinquency and improve cash flow
• Excellent communication, negotiation, and conflict-resolution skills
• High attention to detail and strong analytical skills

Knowledge, Skills and Abilities:

• Excellent communication skills
• Credit risk assessment
• Collections strategy and execution
• Financial analysis and reporting
• Cross-functional influence
• Policy development and governance
• Customer-centric problem solving
• Leadership and team development

Education:
Minimum required:

• BA/BS degree in Finance, Business or equivalent practical experience

Pay Rate Range: $30-45/hr depending on experience ]]> Wed, 04 Mar 2026 00:00:00 EST 1 Wed, 04 Mar 2026 00:00:00 EST 1 Target Pay Rate: 60-70/hr **salary will be commensurate with experience 
 

Job Responsibilities: 

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.  Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.  Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
• Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
• Verifies site compliance with electronic data capture requirements.

May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. 

Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.  

Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.  Supports subject/patient recruitment, retention and awareness strategies.  Enters data into tracking systems as required to track all observations, ongoing status and action items to resolution.

Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.  Must be able to quickly adapt to changing priorities to achieve goals / targets.  

May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.  Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.  Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.      Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.   

May provide direct supervision, training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff, as assigned.

May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings.

Additional responsibilities include:

Site support throughout the study lifecycle from site identification through close-out

Knowledge of local requirements for real world late phase study designs

Chart abstraction activities and data collection

As required, collaborate and build relationship with Sponsor and other affiliates, medical science liaisons and local country staff

The SMA II may be requested to train junior staff

Identify and communicate out of scope activities to Lead CRA/Project Manager

Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations.

Identify operational efficiencies and process improvements

Develop study and country level informed consent forms

Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared

Participate in bid defense meetings

Provide input into Requests for Proposals (RFPs), scope and budgeting. Develop site management strategy.  

Participate in Case Report Form design and edit check development.   
What we’re looking for:

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected. 
• Ability to manage required travel of up  to 75% on a regular basis

]]> Wed, 04 Mar 2026 00:00:00 EST 0

We are seeking a Tender & Bid Team Leader to coordinate complex tender submissions and lead a small, high-performing team within a healthcare environment. This role is ideal for someone with solid experience in tender management who is ready to step into leadership—or a current people manager who wants to remain hands-on with day?to?day tender delivery.

You will oversee end-to-end tender processes, ensure compliance with healthcare procurement standards, and work closely with stakeholders across commercial, technical, financial, and operational functions.
What You’ll Do

• Lead, support and develop a team of three Tender & Bid Specialists/Administrators, fostering a culture of excellence.
• Coordinate the full tender and bid lifecycle, ensuring timely, accurate and high?quality submissions.
• Oversee tender SOPs and ensure compliance with legal, regulatory and procurement requirements.
• Champion ESG, sustainability and social value elements within tender responses.
• Consolidate commercial, financial and technical information to support complex bids.
• Drive process improvements, optimise workflows and address performance gaps.
• Manage performance reporting and support sales with tender?related insights.
• Collaborate with internal stakeholders and external partners to ensure aligned, compliant and competitive submissions.
• Support additional tender/contract activities as needed.

What You Bring

• Minimum 3 years’ experience in tender/bid management or related commercial roles.
• Solid understanding of healthcare tender processes; NHS procurement knowledge strongly preferred.
• Skilled in drafting, coordinating and optimising complex bids.
• Strong stakeholder?management and people?management capability — either as a current manager or a senior specialist with first leadership experience.
• Confident user of MS Office and SharePoint; Power BI is an advantage.
• Degree in business, science, economics or a related discipline (or equivalent experience).
• Strong communication, organisation and coordination skills.

]]> Wed, 04 Mar 2026 00:00:00 EST 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, 04 Mar 2026 00:00:00 EST 1 Animal Care Technician

Performs animal husbandry and health care in accordance with experimental protocol and Animal Welfare Act/Regulations, NIH Guide for the Care and Use of Laboratory Animals, Guide for the Care and use of Agricultural Animals in Research and Teaching, Veterinary Sciences standard operating procedures, and the fundamental requirements for AAALAC accreditation.  In addition, this individual assists with scientific procedures in accordance with study protocols, completes and maintains appropriate documentation associated with all job assignments, and provides equipment sanitation and facility maintenance. This individual will work in an animal research laboratory setting under Biosafety conditions.

Duties & Responsibilities:

• Complies with applicable regulations and company policies. Documents and maintains records of animal care, preventive medicine, USDA-required, and study protocol-driven documents. Provides animal husbandry and care including provision of feed, water, and enrichment materials. Maintains, adjusts, and repairs animal pens, feeders, drinking systems, and livestock handling equipment. Performs cleaning and sanitation of animal rooms and equipment.
• Recognizes when animals are sick, distressed or otherwise abnormal and communicates these observations to the Site Veterinarian or Group/Team Leader. Conducts daily animal health and welfare assessments.
• Conducts scientific clinical observations and assessments.
• May perform site biosecurity functions including water system sanitation, bagged feed and fomite decontamination, and environmental auditing sample collection.
• Assists with clinical R&D sample collection in accordance with study protocols and direction of Investigator or delegate

Skills:    
Requirements:

• This position requires a High School diploma or equivalent degree (GED) and a minimum of two (2) years experience in a related field. Such fields may include livestock handling, husbandry, and healthcare, veterinary clinical assistance, and/or scientific animal research. This related experience may be obtained concurrent with the diploma/degree.
• This person should either already possess or be willing to obtain Assistant Laboratory Animal Technician (ALAT) certification, preferably within 12 months of employment. Certification timelines will be dependent upon prior education and experience.

Physical and Mental Requirements to Perform Essential Functions:

1. Physical Demands / Surroundings - This position requires the ability to work in inclement environments (hot, cold, noisy, humid, etc.) with a high priority focused on biosecurity, attention to detail, and timeliness. Individual must demonstrate persistence and energy in a dynamic, fast-paced, and demanding work environment. Some heavy lifting is required and must be able to lift up to 70 pounds occasionally and up to 50 pounds frequently. Travel outside of local area is rarely required. Must be willing to work directly with animals. This person must not have allergies to animals or livestock/feed dust.
2. Visual Demands – Must be able to read and see clearly. Prescription eye wear is allowed.
3. Temperament / Mental Requirements - Must be able to maintain even temperament when working with all animals. Position requires willingness to learn at a rapid pace. Individual must be results oriented, cooperative, and a systematic thinker. Must be able to work in a multi-disciplinary matrix environment and value the importance of teamwork. Must exhibit sound judgment and analytical thinking. This person must demonstrate ability to manage processes, projects, and to function well in a team or committee role.
4. Other Proficiencies – Must possess effective verbal and written communication skills in English, sufficient for accurate transmission of information internally. Requires ability to interface and build working relationships with team members at all levels of site organization. Must be proficient in basic computing skills such as e-mail communication and word processing.
5. Attendance / Schedule – Attendance requirements are based upon BI AH general attendance policies. Must have reliable transportation and must be able to work weekends.
6. These physical and mental requirements represent a sampling of those considered essential to this position. Although this is an accurate representation, it is by no means complete and may be changed or updated as needed.

Must conduct business in such a manner as to comply with all regulations and policies governing animal care and welfare, scientific procedure, hazardous material, and biological agent containment as set forth by the USDA, EPA, The Guides, management, and other regulatory and accrediting agencies.
 ]]> Wed, 04 Mar 2026 00:00:00 EST 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).

]]> Wed, 04 Mar 2026 00:00:00 EST 1 HM's Top Needs:

1. Experience with Bioburden, Sterility, Endotoxin and Environmental monitoring tests

2. Proficiency with Microsoft office suite and strong technical writing skills

3. Experience in a quality control focused Microbiology lab environment

We are looking for a Microbiologist with experience in supporting medical device manufacturing.  Experience with bioburden, sterility, bacterial endotoxin, and environmental monitoring methods is strongly preferred.   Strong technical writing skills and experience using document control systems is required.


Education Required: Bachelors

Years’ Experience Required: At least 5 years of relevant laboratory experience along with a Bachelor’s degree. 

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes

Work Location:

                Do they need to be local to any MDT office and if so where? North Haven, CT

Does this person need to be on site? If so, full time or part time? Full time, On-Site

HM's Top Needs:
Technical Laboratory Execution:
Executes routine and non-routine microbiological testing in support of medical device sterility assurance programs. Performs bioburden, sterility, and bacterial endotoxin testing in accordance with ISO 11737-1, ISO 11737-2, ISO 11737-3, USP <71>, and AAMI ST72, ensuring adherence to validated methods, laboratory procedures, and data integrity requirements. Conducts Gram staining, microbial assessment, and supports contamination investigations using established laboratory practices.

Environmental Monitoring & Cleanroom Compliance:
Supports environmental monitoring programs aligned with ISO 14644 and ISO 14698, including viable and non-viable sampling, documentation, and escalation of results outside defined limits. Demonstrates working knowledge of cleanroom classifications, aseptic technique, and contamination control principles. Participates in EM excursion investigations and supports implementation of corrective actions to maintain controlled manufacturing environments.

Laboratory Quality & Method Control:
Operates within controlled laboratory systems, ensuring compliance with validated test methods, culture media controls, growth promotion requirements, and equipment performance checks. Supports method suitability, verification, and routine monitoring activities. Ensures accurate and complete test documentation consistent with GDP, laboratory procedures, and regulatory expectations.

 Quality System Integration:
Works within a regulated medical device Quality Management System and demonstrates familiarity with ISO 17025 laboratory requirements, including traceability, method control, data review, and investigation support. Contributes to deviations, non-conformances, and CAPA activities by providing microbiological input and ensuring timely documentation and follow-up actions. Maintains audit-ready records and supports internal, external, and regulatory inspections.

 Data Interpretation & Cross-Functional Support:
Identifies potential microbial risks through routine data review and trending awareness. Escalates atypical results and collaborates with Sterility Assurance, Quality, and Manufacturing teams to support product impact assessments, investigations, and process improvements. Demonstrates awareness of how microbiological testing interfaces with sterilization validation, product release, and manufacturing controls.
]]> Wed, 04 Mar 2026 00:00:00 EST 1 • Responsible for administrative duties in support of an assigned executive or senior leader.
• Organizes and prepares documents for executives, leadership, clients, and team meetings.
• Coordinates meetings and events for executives, leadership team members, board committees, and/or shareholders, as applicable, and assists with minutes for the meetings.
• Assists with managing the travel and expenses of executives, leaders and their teams. Evaluates the travel expenses of the leader’s teams as requested.
• Manages executive and other leader’s calendars and communications to ensure coordination between them and their customers.
• Assists in coordinating activities and maintaining financial and other business records which may include the company’s charitable giving programs. Manages the requisition and alignment of expenses to the appropriate budgets.
• May serve as the administrator of company credit cards.
• Provides project management coordination.
• Other duties as assigned.

Qualifications & Technical Competencies
•    High School diploma required with Associates Degree or Administration certification highly preferred
•    4 years related experience required; executive assistant background preferred. •    Fluency in English is preferred.
•    Knowledge of Microsoft Office programs and functions, with particular proficiency in Word, Excel, SharePoint and PowerPoint
•    Ability to handle confidential information
•    Ability to carry out detailed event planning Working Conditions
•    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.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•    While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms and talk or hear.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
•    Extensive use of computer keyboard.

Pay $22-26/hr]]> Wed, 04 Mar 2026 00:00:00 EST 0 Manager, NPD Program Management 

Job Description:

The NPD (New Product Development) Program Manager will be responsible for successfully leading NPD teams through the various stages of product and algorithm development, clinical evaluations, operational readiness, and commercialization for new and improved Hemodynamic Monitoring products and related accessories and disposables. This person will be responsible for initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of program(s), to ensure on-time commercialization of new products and technologies that uphold best in-class quality standards and business objectives.

Key Responsibilities:

•          Manages one or more large scale to enterprise-wide projects within program, assuring strict adherence to Quality Systems and Change Control Process
•          Facilitates the creation and approval of business cases within the program, and coordinates the sharing and prioritization of resources among projects
•          Develops a detailed plan for the program and manages program change accordingly
•          Executes program plans (quality, risk, communication, staffing, etc.) and communicate program status and data to maintain accurate and current program information for the use of stakeholders
•          Leads core team meetings and other necessary meetings to drive best in class program execution; Continually improves quality and effectiveness of how meetings are run, decisions are made, and how work gets done
•          Serves as a project and program management subject matter expert, including guiding and mentoring peers
•          Demonstrates high emotional intelligence; builds trust, rapport and respect with project team members and stakeholders; Engages in honest and transparent conversations
•          Creates a culture where teams can act with a high sense of urgency and accountability to meeting/exceeding individual and project goals
•          Understands complex problems and drives the team to effective resolution
•          Displays perseverance and continues appropriate forward momentum by keeping core team engaged, even when faced with crisis, and/or changes
•          Demonstrates strong ability to influence downward, horizontally, and upward.

Experience:

•           A minimum of 6 years of hands-on experience managing New Product Developments projects and/or programs of increasing complexity -- Required
•          Demonstrated track record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Hardware and Disposable components – Required
•         Proficient understanding of Medical Device Regulations and Product Development Process – Required
•          Demonstrated track record of leading within complex organizations requiring strong influence management skills
•          Proven expertise in usage of MS Office Suite and related project management systems
•          Ability to see the “big picture” and determine course of action from an overall “best for the business” perspective
•         Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions
•          Ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals.
•          Effective decision-making skills -- ability to negotiate and balance decisions and priorities across needs of several functional departments. Makes timely decisions in the face of risk and uncertainty

Additional Skills:

•          Working knowledge of Agile/Scrum methodology and related project management software: Jira, Microsoft DevOps, etc.
•          Strict attention to detail
•          Ability to lead meetings with external representatives
•          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:

•          Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field – Required
•          Master's Degree or equivalent – Preferred
•          PMP Certification - Plus

Pay $60-67/hr based on experience]]> Wed, 04 Mar 2026 00:00:00 EST 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.]]> Wed, 04 Mar 2026 00:00:00 EST 1 Target Pay Rate: 23/hr **salary will be commensurate with experience 

Job Summary:
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities:
• Executes laboratory experiments; makes detailed observations and analyzes data.
• Prepares technical reports, summaries and quantitative analyses.
• Maintains complete and accurate records.
• Normally receives detailed directions on all work.
• Makes suggestions to improve work processes.
• Assists in reducing to practice patentable inventions.
• Works on projects of moderate scope in which analysis of situation or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• May participate in cross functional technical team activities.
• Presents and discusses data within group.
• Monitors work to ensure quality and continuously promote Quality First Time.
• Other duties as assigned by management.

Education:
Bachelor's in science required with 1 year of experience 

Skills:
• Knows basic and some specialized laboratory techniques.
• Familiar with searching scientific literature.
• Skilled with use of word processing, spreadsheets, graphical and presentation software applications.]]> Wed, 04 Mar 2026 00:00:00 EST 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.]]> Wed, 04 Mar 2026 00:00:00 EST 1 Location:   Luimneach, Munster, Ireland

Req Number: 3435286

Salary: 60-70k EUR


Job Description Summary:

As a Design Assurance Quality Engineer (QE), you will play a key role in ensuring that new product development and sustaining projects meet stringent quality and compliance standards. Acting as the Quality representative on project core teams, you will oversee design controls, risk management, and change control processes while driving adherence to global regulatory requirements. Your responsibilities will span from product inception through launch and maintenance, requiring strong collaboration with cross-functional teams and effective communication skills.

You will lead risk management activities, manage Design History File (DHF) documentation, and support compliance initiatives such as IEC 60601 and IEC 62304. The role involves reviewing and approving verification and validation plans, challenging statistical rationales, and authorizing deviations. You will also assist in failure investigations, software issue tracking, and advocate for a strong quality culture across projects. Additionally, you will contribute to broader Quality Management System (QMS) activities, including CAPA, field assessments, and operational engineering evaluations.

About the role:

As Quality Engineer - Design Assurance, you will be involved in new product development and product sustaining projects through the application of Quality Engineering skills. You will balance multiple projects and tasks, from product inception through product launch and maintenance utilising a high level of written and oral communication skills.

You will play an active role in the processes to ensure products meet quality and compliance standards consistent with both Corporate and global standards and regulations while meeting all design controls, risk management, change control requirements, and other applicable regulatory requirements. The Design Assurance QE represents the Quality Function on the Project core teams for both new product development and existing products.

Main responsibilities: 

• 
  Be the Design Assurance Quality Engineer on project core teams for design change projects and develop close relationships with core team members and extended quality functions as needed for the project.
  
• 
  Contribute to the formation and ongoing management of DHF documentation
  
• 
  Lead risk management activities within the project.
  
• 
  Drive compliance management activities (e.g., IEC 60601) on the project with support from the Compliance Engineer.
  
• 
  Demonstrate a patient-first approach to quality engineering.
  
• 
  Support the creation and implementation of verification and validation activities.
  
• 
  Work closely with R&D functions to ensure comprehensive testing of product requirements and the execution of the V&V plan.
  
• 
  Review and approve testing procedures and documentation.
  
• 
  Review and challenge the statistical rationale and data analysis within the test protocol and reports.
  
• 
  Assess and authorise related execution deviations.
  
• 
  Assist/conduct Failure investigations and problem-solving sessions.
  
• 
  Responsible for the software issue tracking process per IEC 62304 to ensure software issues are logged, risk assessed and dispositioned appropriately.
  
• 
  Ensure compliance across projects for design control, risk management, and change control processes.
  
• 
  Advocate for a strong quality culture within project core teams
  
• 
  Support of other QMS activities outside of projects, such as CAPA, Field Assessment and operations engineering assessments.
  

 

About you

• 
  A relevant degree or equivalent experience (engineering degree preferred), or a minimum of 5 years of quality engineering experience as an equivalent qualification
  
• 
  Knowledge in working with ISO 13485, QSR, ISO 14971, and statistical techniques
  
• 
  Expertise in design assurance, including design controls, standards compliance, and risk management
  
• 
  Strong written and verbal communication skills
  
• 
  Strong organisational skills
  
• 
  Experience with MDR – advantage
  
• 
  Experience with IEC 62304 and IEC 62366 – advantage
  
• Ability to influence. Assess the situation and determine if a blocking issue is triggered.

*7+ to 10 years experience
Mid-Senior
Minimum Education: Bachelor's Degree
Willingness to Travel: Occasionally]]> Wed, 04 Mar 2026 00:00:00 EST 1 Wed, 04 Mar 2026 00:00:00 EST 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

 ]]> Wed, 04 Mar 2026 00:00:00 EST 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 company 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 company 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 28-33/hr based on experience ]]> Wed, 04 Mar 2026 00:00:00 EST 1

6?month contract

An international biopharmaceutical organisation is delivering a major capital project and is looking for an experienced Senior Claims Manager to strengthen its project services function. This is a site?based role within a high?visibility work package, partnering closely with procurement, contracts, engineering, and external delivery partners.
The Role
You’ll take ownership of the project’s commercial claims landscape, ensuring issues are surfaced early, managed proactively, and resolved in a structured and pragmatic way. This role suits someone who thrives in the field, builds trust quickly, and has the confidence to navigate complex stakeholder environments.
What You’ll Do

• Drive the internal process for commercial claim settlements
• Lead contract close?out activities
• Partner closely with the project’s EPCM organisation
• Align with internal stakeholders including legal, finance, procurement, contracts and technical SMEs
• Act as escalation point for ongoing supplier and contractor claims
• Identify and mitigate risks to contractual milestones through active communication
• Provide regular reporting on claim status and progress
• Attend project meetings and ensure stakeholders are kept informed on mitigations and recovery actions
• Conduct regular site walks to validate progress and uncover potential issues
• Bring a forensic, fact?based approach to evaluating claims and risks
• Lead with pragmatism, problem?solving, and hands?on engagement
• Provide team leadership and coaching where needed

What You Bring

• Strong technical background, ideally with prior field experience
• Bachelor’s degree
• 10+ years’ experience in project environments
• Proven experience as a Senior Claims Manager, including team management
• Excellent communication and negotiation skills, Fluent English
• Highly visible, self?driven, and proactive in engaging stakeholders

]]> Wed, 04 Mar 2026 00:00:00 EST 1 Position Summary: Sr. Clinical Trial Manager (Sr. CTM)

Seeking a highly motivated Sr. Clinical Trial Manager (Sr. CTM) to be part of our Clinical Operations team.   This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The SCTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The SCTM will focus on the management and support of multinational, multicenter, Phase III studies and may assume responsibility for additional studies/indications as applicable. The SCTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.

 

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. The SCTM will be responsible for managing various project goals and supporting delivery of a quality clinical trial to meet current business needs and trends.


 

Job Responsibilities

• Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).
• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinate clinical study timelines with Project management and escalate issues that may impact timelines/ deliverables.
• Leads and/or participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan.
• Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.
• Identifies potential study issues/risks, escalates as needed and recommends/implements
• Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review/clean up.
• Coordinate with Lead and Finance to track the financial status against budget.
• Provide regular updates to Study Lead and other stakeholders; Proactively identify, manage, or escalate issues appropriately.
• Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.
• Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization; implementation of PI Training, site monitor training, etc.
• May have some responsibility for the oversight and management of the study budget including site and service provider budgets.
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study specific systems EDC, CTMS, eTMF is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.
• Other supportive duties as assigned to achieve operational

 

Qualifications:

Education

• Bachelor’s degree or equivalent (scientific or healthcare discipline preferred)

 

Experience

• Minimum of 7+ years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope
• Minimum of 3+ years study management experience in clinical and drug development
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.
• Experience in supporting SOP development and implementation is
• Experience working on global teams is desired, Asia-Pacific and EU highly

 

Core Competencies, Knowledge and Skill Requirements 

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials. 

 

Travel Required: Up to 30%
]]> Wed, 04 Mar 2026 00:00:00 EST 0 · Develop, optimize, and maintain Tableau dashboards and reports to support commercial business needs, ensuring clarity, accuracy, and actionable insights.
· Publish reports to Tableau Server or Tableau Cloud; manage scheduled refreshes, monitor data integrity, and ensure ongoing reliability and performance.
· Identify and resolve issues related to data sources, report performance, and user access; Provide ongoing support to end users and escalate technical issues as needed.
· Create, maintain, and troubleshoot data marts using SQL to support reporting needs.
· Administer user and group permissions in Tableau Server or Tableau Cloud, ensuring appropriate access controls and compliance with the company's data governance policies.
· Partner with commercial stakeholders to gather requirements, iterate on report design, and deliver solutions that meet evolving business needs.
· Create and maintain comprehensive documentation for all reports, dashboards, data sources, and processes to support transparency, reproducibility, and knowledge sharing.
· Review existing reports for performance, usability, and alignment with business objectives.
· Support end users with training, onboarding, and best practices to maximize adoption and impact of commercial reporting tools.

Qualifications
· 3+ years of hands-on experience with Tableau Desktop and Tableau Server or Tableau Cloud in a commercial or analytics environment.
· Proficient in designing, publishing, and optimizing Tableau dashboards and reports.
· Strong troubleshooting skills with the ability to resolve data, performance, and access issues.
· Proficient in SQL, with experience creating, maintaining, and troubleshooting data marts for reporting purposes.
· Experience managing user permissions and security in Tableau Server/Tableau Cloud.
· Ability to clearly and thoroughly document processes, data sources, and report logic.
· Excellent communication and collaboration skills; able to partner effectively with diverse stakeholders.
· Experience in the pharmaceutical, biotech, or healthcare industry preferred.
· Strong attention to detail and data troubleshooting skills.
· Familiarity with data warehouse processes.
· Experience with R or Python for data analysis or automation is a plus.

Capabilities:
· Ability to partner with cross-functional stakeholders to translate business needs into actionable technical requirements and deliver impactful Tableau-based reporting solutions.
· Proven ability to analyze complex, disparate data sources (e.g., Hub/Patient Services, Specialty Pharmacy, Specialty Distributor, 3rd Party Logistics partners, VEEVA CRM, Diagnostic Testing Data) and synthesize insights into clear, actionable information.
· Strong analytical and problem-solving skills, with the ability to communicate findings clearly to stakeholders.
· Experience coaching and enabling others on Tableau reporting skills within a self-service analytics environment is a plus.
· Experience with Power BI is a plus; Tableau expertise is essential for this role. ]]> Wed, 04 Mar 2026 00:00:00 EST 1 Must Have

•  Computer literacy in MS Word, Excel, PowerPoint
•  SAP APO SNP & Deployment

Nice To Have

• Blue Yonder
• Blue Yonder Luminate Planning
• Excel, SAP and PowerBI, Visio

Responsibilities may include the following and other duties may be assigned. 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 5 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.]]> Wed, 04 Mar 2026 00:00:00 EST 1
Procure and drive engagement of appropriate resources.

Manage and keep appropriate schedule and effectively communicate changes, impact and resolutions to key stakeholders to ensure proper action is taken in all areas.

Interface with key stakeholders, vendors and subcontractors to secure a diverse range of services required during the project(s).

Properly delegate and oversee the execution of project deliverables utilizing current process and implement improvement when needed to insure highest level of efficiency in execution and customer satisfaction.

Maintain constant communication with customers to address projects’ progress, including accomplishments, challenges and deliverables to keep complete transparency in the process.

Maintain communication with Regional Project Manager to address progress, challenges and other aspects of the business.

Maintain records of time and costs to ensure accurate accountability of project resources and finance elements.

Assist with refinement of operational metrics to insure continuous improvement for current and future process.

Utilize collected data to develop strategic action plans for cost savings and efficiency opportunities.]]> Tue, 03 Mar 2026 00:00:00 EST 1 Country Commercial Lead / Commercial Director – China
Location: Beijing preferred | Remote within China
Employment Type: Full-time, permanent

About the Company
Our client is a US-based, independent, nonprofit biomedical research organisation specialising in genetics, genomics, and disease modelling. The organisation is globally recognised for advancing scientific discovery and improving human health through research, education, and innovation.
As part of continued international expansion, the organisation is strengthening its China commercial presence and is seeking a senior commercial leader to drive long-term growth in the market.

About the Role
The Country Commercial Lead / Commercial Director – China plays a pivotal role in executing the organisation’s growth strategy in China. Reporting into a US-based International Sales Leadership function, this role partners closely with global stakeholders to define and deliver country-level commercial plans across the drug discovery and human health research markets.
This leader will own the China commercial strategy, oversee local business operations, and help build a scalable, sustainable commercial foundation aligned with global objectives. The role requires strong distributor and partnership management experience, a hands-on and entrepreneurial mindset, and the ability to translate strategy into measurable regional outcomes.

Key Responsibilities
Customer & Market Leadership

• Build and maintain senior relationships with key customers across pharma, biotech, and academic research organisations
• Establish the organisation as a trusted, long-term partner within the China research ecosystem
• Develop and execute sales forecasting, market penetration, and customer engagement strategies to drive sustainable revenue growth
• Maintain a visible market presence, including customer engagement and industry events, to gather insights and strengthen brand positioning

Distributor & Partner Management

• Own and evolve the distributor and channel strategy in China in close partnership with global leadership
• Lead distributor onboarding, enablement, performance management, and quarterly business reviews
• Hold partners accountable to revenue targets, activity plans, and compliance standards while maintaining collaborative relationships

Business Development & Strategy

• Identify new commercial opportunities and contribute to broader regional and global strategies
• Act as a key source of China market intelligence for senior commercial leadership
• Leverage competitive insights to refine positioning and unlock growth opportunities

Team & Operational Leadership

• Oversee and grow the China-based team over time, acting as a people leader and mentor
• Own regional business planning, forecasting, execution, and performance management
• Provide oversight of local financial operations and ensure strong compliance and governance standards

Ideal Profile
Commercial Leadership

• Trusted, dependable commercial leader with a strong market reputation
• Track record of building, stabilising, and growing partnerships
• Comfortable operating in complex or evolving environments

Experience & Background

• 7+ years of commercial or sales leadership experience within life sciences, biotech, CROs, or pharmaceutical environments
• Experience within multinational organisations; international exposure beneficial but not essential
• Proven ability to build or scale commercial operations in China
• Background open to candidates from biotech, CRO, or adjacent life sciences services

Leadership & Mindset

• Capable of stepping into a people management role and building a team over time
• Strong communicator able to influence across cultures and seniority levels
• Comfortable operating autonomously while remaining aligned with global leadership

Cultural & Mission Fit

• Motivated by working in a mission-driven, nonprofit environment
• Values long-term impact, scientific advancement, and partnership-led growth
• Energised by the opportunity to shape the organisation’s next phase of growth in China

Why This Opportunity
This role offers a rare opportunity to build and shape a China commercial function with strong backing from global leadership. It suits a senior commercial leader seeking impact, autonomy, and the chance to play a foundational role in a growing, science-led organisation.]]> Tue, 03 Mar 2026 00:00:00 EST 1 *depending on experience
Job Description Summary:

The Instrument Readiness Specialist provides operational and technical support for LC-MS, HPLC, and GC-MS laboratories at Customer facilities in Delaware. This role is responsible for routine instrument operation, sample preparation support, preventive maintenance, performance monitoring, and compliant documentation in accordance with Customer-defined SOPs, validated methods, and regulatory requirements. The position requires strong attention to detail, the ability to work independently in a laboratory environment, and effective collaboration with Customer scientists and project stakeholders to ensure reliable analytical operations.

Job Responsibilities
• Provide hands-on operational support for LC-MS, HPLC, and GC-MS instrumentation at Customer facilities, including the DuPont Experimental Station (Wilmington, DE) and New Castle, DE, in accordance with Customer-defined SOPs, validated methods, and applicable compliance requirements.
• Perform routine operation of analytical systems, including instrument startup and shutdown, method loading, sequence and sample queue setup, data acquisition, and basic system checks.
• Support sample preparation activities such as dilution, extraction, filtration, derivatization (as applicable), reagent preparation, consumable selection, and proper sample labeling following Customer-approved procedures.
• Monitor and assess instrument performance, including chromatographic stability, pressure and flow profiles, vacuum system performance, detector response, ion source condition, mass accuracy, and column integrity; promptly communicate deviations or abnormal trends to Customer stakeholders.
• Conduct routine preventive maintenance and system upkeep, including solvent and mobile phase preparation, degassing, tubing and fitting inspection, leak checks, column flushing, injector and ion source cleaning, vacuum pump monitoring, tuning verification, and routine calibration in alignment with manufacturer recommendations and Customer requirements.
• Support day-to-day laboratory operations, including equipment readiness, workflow coordination, and effective communication with Customer project leads and local stakeholders.
• Comply with all site-specific safety, laboratory access, emergency response, and environmental health requirements; participate in required safety, EHS, and instrumentation training programs.
• Maintain accurate and timely documentation of instrument usage, maintenance activities, experimental observations, deviations, and corrective actions in accordance with Customer documentation practices and data integrity standards.
• Prepare and provide analytical summaries, instrument performance logs, and status updates as requested or defined by project timelines.
• Ensure proper archiving of raw data, chromatographic results, mass spectral files, electronic logs, and supporting documentation within Customer systems.
• Document and escalate deviations, nonconformances, or unexpected findings in a timely manner and support quality assurance, audit readiness, and inspection activities related to analytical services, as requested.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Critical Skills:
• Working knowledge of LC-MS, HPLC, and GC-MS instrumentation and associated laboratory workflows
• Ability to operate analytical instruments in accordance with SOPs, validated methods, and compliance requirements
• Strong attention to detail and commitment to data integrity and accurate documentation
• Ability to monitor instrument performance, identify deviations or abnormal trends, and escalate issues appropriately
• Hands-on experience with routine instrument maintenance, troubleshooting, and preventive care
• Strong organizational and time-management skills in a fast-paced laboratory environment
• Ability to follow written and verbal instructions and adhere to established procedures
• Effective communication skills and ability to collaborate with scientists, vendors, and site stakeholders
• Ability to work independently with minimal supervision while supporting team objectives

Basic Qualifications:
One of the following education and experience combinations:
• Bachelor’s degree in chemistry, biology, biochemistry, or a related scientific discipline with 3 or more years of relevant laboratory experience supporting analytical instrumentation
• Associate’s degree in a scientific or technical discipline with 5 or more years of hands-on experience supporting LC-MS, HPLC, or GC-MS systems
• High School diploma or GED with 7 or more years of directly related laboratory experience in an analytical environment
Basic proficiency with Microsoft Office applications, including Excel, Word, Outlook, and PowerPoint

Preferred Qualifications:
• 5 or more years of experience supporting LC-MS, HPLC, and/or GC-MS instrumentation in an industrial, academic, or regulated laboratory setting
• Master’s degree in chemistry, analytical science, or a related scientific discipline
• Experience working in SOP-driven or regulated laboratory environments (e.g., GLP, GMP, or similar frameworks)
• Familiarity with analytical data systems, electronic laboratory notebooks (ELNs), and data archiving practices
• Demonstrated ability to support audit readiness, inspections, or quality assurance activities related to analytical laboratories

Working Environment:
• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.
• Job pace may be fast and job completion demands may be high.
• Must be able to remain in a stationary position more than 25% of the time
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.]]> Tue, 03 Mar 2026 00:00:00 EST 1 *depending on experience

Description:
The Senior project Engineer 3 oversees the seamless transition of manufacturing processes from one location to another, ensuring minimal disruption. Responsibilities include coordinating with cross-functional teams, managing timelines, and maintaining product quality during the transfer. The role requires expertise in process optimization, problem-solving, and compliance with industry standards. Strong communication skills are essential for liaising with stakeholders, including engineering, quality, regulatory, supply planning, procurement, and production teams. Senior Project Engineer 3 also monitors and reports on progress, ensuring that all project objectives are met efficiently.

What will you be doing.
• Manage the transfer of manufacturing processes between locations, ensuring minimal disruption to production.
• Create detailed project plans, including timelines, resource allocation, and milestones for the transfer process.
• Work closely with engineering, quality assurance, regulatory, supply planning, procurement, production teams, and suppliers to align objectives and address potential issues.
• Identify opportunities for process improvement and implement changes to enhance efficiency and product quality.
• Ensure all processes adhere to industry standards, safety regulations, and company policies.
• Track and report on the progress of the transfer project, addressing any deviations from the plan.
• Resolve any technical or logistical problems that arise during the transfer to avoid delays and maintain production continuity.
• Prepare documentation and provide training to ensure the receiving location can operate the new processes effectively.


What will you need to be successful?
• Bachelor’s degree in science or engineering and at least 5 years’ professional work experience in new product development, product transfer in a regulated industry (Med Device preferred).
• Experience with medical device manufacturing methods is highly desirable.
• Communicate optimally, while working with multi-functional teams, to achieve desired results.
• Build productive internal/external relationships and collaborate in teams.
• Complete assignments with directional input and periodic mentorship.
• The ability to understand, interpret, follow, and improve Inspection, gauging methods and different Quality Systems.
• Requires organizational and time management skills.
• Understand basic technical issues and develop solutions with scope of responsibilities.
• Basic knowledge of Operations deliverables / documentation is preferred.
• Duties and responsibilities may change as business needs change.
• Having GD&T knowledge will be beneficial.
• Strong verbal and written communication and presentation skills.]]> Tue, 03 Mar 2026 00:00:00 EST 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. 
  

]]> Tue, 03 Mar 2026 00:00:00 EST 1 Role Description:

We are seeking a Software Test Engineer (Contractor) to support our growing portfolio of electromechanical medical devices with embedded software. This is a mid-level role that involves primarily manual testing of software with the ability to identify defects and some potential test automation work.
 

Responsibilities:

Support software testing of electromechanical medical devices.

Analyze requirements and write test cases for software V&V.

Perform manual testing including dry runs, smoke testing, integration testing and identify defects.

Develop and maintain automated test cases.

Collaborate closely with software developers and cross-functional teams.

Prepare documentation of test reports.

 

Minimum Qualifications:

Bachelor’s degree in Computer Science, Computer Engineering or Electrical/Software related field.

2 to 6 years of experience in software testing, including manual and some automation testing.

 

Nice to Have:

Experience developing automated tests using Python and/or LabVIEW.

Embedded systems testing background.

Familiarity with Microsoft Azure DevOps.

 

Soft Skills:

Team-oriented and easy to collaborate with.

Good communication skills.

Commitment to Quality.

Onsite - pay, $40-41/hr
]]> Tue, 03 Mar 2026 00:00:00 EST 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 ]]> Tue, 03 Mar 2026 00:00:00 EST 1 Only 4 suppliers helping with these roles (very good odds to fill these!)
They have 2 openings at the Sr. RA level 

• Interviews; 25 min virtual panel (typically 3 people). Feel free to add interview availability in the summary for these days!
• Provide email address/phone/location/LI at the top of resumes! Please provide info if there is a gap in employment/relo
• Will reconfirm before interview that they are submitted to the correct level (are they qualified in terms of YOE).
• Professional experience starts AFTER graduation
• Skills listed on the resume will be asked about! Please ensure they can speak to their experience

We can resubmit candidates that have iv’ed in the past (they may not have been selected then but if they weren’t rejected for cause, definitely submit them again)
We have direct contact with managers on these (this is huge and usually not allowed)
Include candidate contact info on the resume for these (this will speed up the process)
Candidates have to be able to make selected interview times - if they miss their spot, they don't usually rebook them (they are deciding on if these will be in person or virtual, tbd).
Hard start date listed – they have a 3 week training program so they have to be able to start this day (no exceptions/flex on this start date).
All roles fully onsite (8-5) in Tucson
When you get the invite – note the title – they may level up/down with the candidate after reviewing if they are a better fit for a different level (we will need to go over that level requested during the interview and rate to make sure they are ok with it).
Candidates should reach out to us regarding status after interview (please ask them not to contact the team directly – they want us to coordinate this).

• Conversions – not a guarantee but they can apply to FTE roles as they open, and there is a chance that they could convert.
• These hires support projects within assay development (these are not on the R&D side)
• Iv’s – candidates will meet with a SME or Technical lead – panel iv with 2-3 people, about 25 minute interviews. One interview for these roles (unless they may be a better fit for another group, in which case they may have a 2nd interview to meet with that team – this would be a one off situation)

All roles for the TPS group – 

These will move but we have to get candidates in quickly – double check your Ventana pipeline, ok to resub anyone that is still available/interested that you submitted to previous roles!

Important: Start date for all roles, they have to be able to start on this day – if they can’t be available on this day, they can’t be considered.

Important: Interviews will be virtual – they have to be able to make these interview dates or they can’t be considered. 

They want us to submit the candidate to the appropriate JD/level – don’t cross submit between these roles, all of the managers are looking at these candidates collectively and will consider them for the roles they think they are a fit for – just sub them to the one that you think is closest and they will take it from there.

Roles are open to support ongoing projects – this is a peak period for them. This is a very large business group supporting personalized healthcare solutions.

Experience is only considered post education (academic experience during school doesn’t count as experience per the requirements below). If they are completing a Masters (like at night) and working during the day in an industry job, this time would count.

Anyone who has worked in a regulated industry is good, familiarity with lab techniques, any experience in IHC, in situ, writing technical summaries and qualitative analysis are helpful for them, they do a lot of protocol analysis and writing. For soft skills – they look for good communication, prioritization, and ability to execute a task

They don’t do a lot of conversions in this group but they do have them apply to Roche openings as they come up (and sometimes they get these jobs).

Looking for familiarity with lab techniques, general safety knowledge, familiarity with defined procedures and practices is a huge plus for them and ability to make judgments. Prioritize and execute tasks once they are trained and communicate concerns in a timely manner. Wet lab experience is good for this one.          

HM - Valeria Cooper

Note, they are firm on degree and years of experience, if they don't meet the requirements, they can't be hired at this level but if they are a little light we may be able to get them considered for a lower title in the same group (like if they are a bit shy of the requirements but they need to be close at least). 
**Ask if they have been submitted by other agencies - if we double sub them we lose the resume slot and I can't get more so we don't want to burn any resume slots if we can help it**

Looking for investigation and root cause analysis, experience in regulated environment, familiarity with GDP, experience with CAPA/MDR reporting, Elisa, IHC, problem solving, troubleshooting, experience using databases and or resources to compile and present data

They use SAP for data collection and googleslides, and minitab

HM - Danielle Rodriguez

**Ask if they have been submitted by other agencies - if we double sub them we lose the resume slot and I can't get more so we don't want to burn any resume slots if we can help it**

Pay $38/hr
2yr contract 
Onsite in Tucson, AZ
Vax not required 
Ok to xsub from other roles if they are qualified

Sr. RA
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to
support Ventana projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments
that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and
discusses results of experiments within department and project team. Maintains high level of professional expertise through
familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and
procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation
and electronic files. May act as principal investigator in conducting own experiments.
Responsibilities
• Designs experimental plan to support project objectives.
• Executes bench experiments; makes detailed and general observations and analyzes data.
• Prepares technical reports, summaries and quantitative analyses.
• Maintains complete and accurate records.
• Normally acts independently for developing methods, techniques and evaluation criteria for obtaining results.
• Identifies and implements improvements to work processes and laboratory environment.
• Recognized expert across a wide range of techniques and their application.
• Recognizes and documents activities for publication and/or patent potential.
• May participate in scientific conferences and contribute to scientific journals.
• Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Participates or leads cross functional technical teams such as a failure investigation or core team.
• Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and
providing input to project planning.
• Establishes interfaces across other organizational groups.
• Trains others in areas of expertise.
• May supervise lower level personnel and laboratory operations.
• Troubleshoots problems and institutes corrective action.
• Prepares and presents experimental procedures and results in group and project teams.
• Monitors work to ensure quality, and continuously promote Quality First Time.
• Other duties as assigned by management.

Minimum Qualifications
MS in Biology/Chemistry/Biochemisty or related field with ~1 year or more experience (Preferred) or a 
BS in Biology/Chemistry/Biochemistry or related field with 6 yrs or more demonstrating progressive work
experience of increased competencies

• Knows a wide range of experimental techniques and is skilled in their applications. • Acts independently to determine methods and procedures on new assignments. • Capable of searching scientific literature to gain general and specific information. • Skilled with use of word processing, spreadsheets, graphical and presentation.
]]> Tue, 03 Mar 2026 00:00:00 EST 1 The Commercial Learning and Leadership Development (CL&LD) team has an opening for a contract role to support the coordination of commercial learning activities. The position will require working closely with stakeholders in the field and home office who support the client's brands as well as Leadership Development and Market Access. The ideal candidate should be able to manage multiple projects while maintaining attention to detail and timelines.

Key Responsibilities:

·Stakeholder Collaboration: Work closely with Learning Team and other stakeholders to meet department goals.

·Onboarding New Hires: Management of new hire training experience (initial contact, materials, scheduling calls, aligning with internal stakeholders on planning and logistics & ongoing communication).

·Program Coordination: Manage the scheduling, logistics, and execution of training sessions. Document meeting notes and action items and collaborate with internal and external stakeholders to complete outstanding tasks.

·Support Services: Provide support to participants and instructors, addressing any issues or concerns that arise during the learning process.

·Platform Management: Oversee the day-to-day operations of the learning platform(s), ensuring it runs smoothly and efficiently. Lead platform administration responsibilities, including user profile management, asset tracking, reporting and data analysis, troubleshooting support, and additional administrative tasks as assigned.

·Content Curation: Upload, organize, and maintain high-quality educational content on the platform, ensuring it meets the needs of learners.

·Survey Administration: Use survey tools and platforms to build and distribute surveys to the target audience. Lead the creation and ongoing reporting of survey dashboards.

·Complete all other duties as assigned

Qualifications:

·Bachelor’s degree required, with 3-5 years of relevant experience.

·Proven experience in coordinating educational programs or training sessions.

·Strong organizational and communication skills.

·Ability to work collaboratively with diverse groups.

·Proficiency in using educational technology and software.

Skills:

·Strong working knowledge of MS Office(Outlook, PowerPoint, Word, Excel, and SharePoint).

·Excellent project management and time management skills. Keeping track of multiple projects, resources, and schedules to maintain order and efficiency.

·Strong interpersonal and communication abilities.

·Analytical skills for program evaluation.

·Adaptability and problem-solving skills.

·       Ability to work independently in a proactive manner to anticipate and solve problems
]]> Tue, 03 Mar 2026 00:00:00 EST 1 Strategic Feasibility Lead

Are you a visionary strategic thinker with a knack for assessing complex opportunities? We’re seeking a dynamic Strategic Feasibility Lead to guide our organization through critical growth initiatives and future projects. This pivotal role offers the chance to influence high-impact decisions, working closely with leadership to evaluate the viability of transformative ventures. Join us to shape the future landscape of our operations, contributing your expertise to drive sustainable success.

Required Skills:

• Proven experience in strategic analysis, feasibility assessments, or similar roles
• Strong analytical and problem-solving abilities
• Excellent communication and stakeholder management skills
• Ability to interpret data and market trends to inform decision-making
• Proficiency in project management and strategic planning tools
• Autonomous work ethic with strong attention to detail

Nice to Have Skills:

• Knowledge of the industry landscape and market dynamics
• Experience working in a fast-paced, evolving environment
• Familiarity with remote collaboration tools and virtual working setups
• Prior experience supporting office relocations or large-scale transformation projects

Preferred Education and Experience:

• Bachelor’s degree in Business Administration, Strategy, or related field; Master’s preferred
• Several years of relevant experience in strategic feasibility, corporate development, or consulting roles
• Track record of successfully leading complex assessments and articulating strategic insights

Other Requirements:

• Flexibility to consider fully remote options within the UK or hybrid working arrangements
• A proactive mindset and ability to work effectively within deadlines and changing priorities
• This role is offered as a 37.5-hour week, full-time position with an initial contract duration projected until at least the end of 2026.

If you’re ready to make a strategic impact and guide pivotal projects that shape our future, we want to hear from you—apply now to become a key driver of our growth journey!
]]> Tue, 03 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 *depending on exp

Reporting to the structure of the Director of Strategy, Technology, and Operations Excellence for Advance Wound Management (AWM), the Sr Program & Project Manager is responsible for leading the Program/Project assigned and partnering with the team and other key stakeholders, this position executes and manage transformational programs aligned to Strategic Imperatives. As part of overall Program Management, this position ensures a comprehensive People Plan, Risk Management, conflict resolution and Change Management approach, throughout the program life cycle. This position leads and motivates cross-functional and cross-cultural teams, possesses high level of stakeholder management skills with ability to think strategically, while managing the tactical details. The successful candidate will possess excellent communication and presentation skills as well as demonstrated ability to interface effectively with employees, leaders and consultants of all levels throughout the organization. This position requires strong Manufacturing functional and process knowledge as well as demonstrated ability to effectively influence without authority. Travel requirement is dependent upon assigned programs to include location and complexity and could be up 25% travel at times.

The role will lead the program from start to finish, including the planning phase (currently at high-level scope). No construction activities anticipated; the focus will be on process improvement, process qualification, capacity expansion, new equipment purchasing, commissioning, and ramp-up across technical and people workstreams.

Emphasize:
Leadership & Communication: strong ability to lead cross-functional teams, multiple workstreams, project managers and to communicate complex information clearly (written and verbal)
Strategic thinking: Identify impacts, synthesize requirements, guide strategy
Project Management: Budget management, risk assessment, detailed planning, and execution
Industry knowledge: deep understanding of pharma/biopharma industry and regulatory pathways (FDA)
Adaptability: Thriving in a fast-paced environment

There will be a construction piece. At minimum there will be reconfiguration of rooms in production area, and very possibly reinforcement of floors and raising/breaking through the roof to accommodate equipment. That is without a warehouse or outside piece, which I think is very possible.
An on-site warehouse is one potential solution to an issue that needs to be resolved in the 1st path: how materials, finished product, and waste streams will move and be staged. We currently don't have this space onsite, or access to external warehouse space 24/7, which would be required. We also need a solution for HAZMAT waste, which probably requires a separate CER if not incorporated into this solution. This cannot wait to be addressed in 2027, when production levels have already doubled. This person would lead project work from where it has progressed to that point, which depends on when the person starts here.]]> Tue, 03 Mar 2026 00:00:00 EST 1   JOB DESCRIPTION
This position is responsible for manufacturing and product Quality activities. This role is within Mfg/Ops Quality organization and is accountable for supporting day to day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.

This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have  quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and other ad hoc sustaining manufacturing requests. 

 
Responsibilities:

• Provide ongoing quality engineering support throughout the product life cycle.
• 
  Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
  
• 
  Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions.
  
• 
  Support process risk management activities and ensure quality and completeness of validation packages, and change orders.
  
• 
  Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
  
• 
  Review verification and validation reports and identify gaps for GMP compliance.
  
• 
  Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
  
• 
  Coordinate issue resolution using a risk-based approach.
  
• 
  Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
  
• 
  Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
  
• Collaborate with counterparts and cross-functional teams at other sites.
• 
  Other activities as assigned.
  

]]> Tue, 03 Mar 2026 00:00:00 EST 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]]> Tue, 03 Mar 2026 00:00:00 EST 1
The Protein Therapeutics (PT) group is seeking a highly motivated Associate Scientist to join the Protein Chemistry team at our state-of-the-art research facility in Thousand Oaks, CA. PT is a multidisciplinary team with broad capabilities in protein engineering, expression, purification, and characterization.

The ideal candidate will have a strong background in biochemistry and hands-on experience with protein purification and analytics, using various preparative and analytical chromatography techniques in a lab-based environment. Proficiency with lab software such as Unicorn, Chromeleon, or ChromeLab is preferred, along with familiarity with lab automation and high-throughput purification workflows.
They should demonstrate strong troubleshooting skills, attention to detail, and robust data handling capabilities, as well as excellent communication skills suited to a fast-paced laboratory setting. Candidates must hold a bachelor’s degree with at least 3 years of relevant experience or a master’s degree with at least 1 year experience. This is a full-time, onsite position in Thousand Oaks, operating during standard business hours for a minimum duration of 1 year. Applicants without experience in protein purification or protein analytics will not be considered.

Preferred Qualifications:
• Experience with protein purification with expertise in a variety of chromatography techniques (affinity, ion-exchange, size-exclusion, etc.) and software (Unicorn, ChromLab)
• Experience with protein analytical techniques (HPLC, MCE, etc.) and analysis software (Chromeleon, LabChip)
• Experience with data management and/or analysis platform, software or tools is a plus
• Ability to multi-task, work flexibly and efficiently in a cross-functional environment
• Attention to detail; strong communication and interpersonal skills]]> Tue, 03 Mar 2026 00:00:00 EST 1 Packaging Equipment Engineer – Join a Growing Leader in Pharmaceutical Manufacturing

Are you a seasoned machinery expert with a passion for precision and quality? We’re seeking experienced Engineers to join our dynamic Packaging Department. As a vital part of our fast-growing team, you’ll play a crucial role in ensuring our packaging lines operate seamlessly, adhering strictly to GMP standards. This is an exceptional opportunity to advance your career in a technically demanding environment, with potential for long-term relocation and development. If you thrive on hands-on technical work and want to be part of an innovative, multicultural team, we want to hear from you now!

What You’ll Bring:

• Hands-on experience working with packaging machines in pharmaceutical manufacturing
• Strong technical background with vocational education in mechanical, electrical, metallurgical, or related disciplines.
• Proven ability to install, troubleshoot, and maintain packaging or production machinery independently.
• Excellent problem-solving skills and a meticulous, organized approach.
• Good communication skills and fluent English.
• Ability to work effectively across three shifts (with some flexibility).

Nice to Have:

• Experience with Uhlmann packaging lines, blister machines, cartoning equipment, or similar complex machinery.
• Knowledge of GMP standards or pharmaceutical packaging environment.
• Previous experience working in international or multicultural settings.

Preferred Education & Experience:

• Vocational qualification relevant to machinery or manufacturing disciplines.
• At least 5 years of experience in a technical or engineering role involving machinery maintenance and operation.
• Track record of working with automated packaging lines or similar complex systems.

Other Requirements:

• Willingness to relocate to Iceland—with support for visa, housing, and logistical arrangements.
• Availability for shift work, including nights, with a flexible approach if needed.
• Commitment to safety, quality, and continuous process improvement.

This is your chance to become a key player in a pioneering pharmaceutical company experiencing rapid growth. Take the next step in your career—apply now and help us deliver excellence from Iceland to the world!
]]> Tue, 03 Mar 2026 00:00:00 EST 1
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.]]> Tue, 03 Mar 2026 00:00:00 EST 1 Position Summary: Sr CTA

The Senior Clinical Trial Associate (Sr CTA) acts as a central contact for the designated clinical study team and in this key support role supports the team in the planning, implementation, and completion of clinical studies both outsourced or in-house, through interaction with investigative sites, vendors, and team members. The CTA, under the direction and guidance of team members will work independently but knows when to involve and or collaborate with other functional members in the execution of role & responsibilities.

 

Job Responsibilities:

• Obtains, reviews, processes, and tracks study related documents (CVs, FDA 1572s, lab certifications, IRB approvals, contracts, protocols, etc.)
• Sets-up and maintains/ closes out the Trial Master File (TMF/eTMF), perform QC as assigned and resolves discrepancies.
• Maintain and update study metrics as necessary, including, but not limited to: Visit Reports, Regulatory Documents, site and team contact lists, vendor lists, etc.
• Facilitate with the preparation of agendas and takes comprehensive minutes for internal and external meetings.
• Accountable for study level tracking as assigned, e.g. monitor visit tracking, sample tracking, study related supplies etc.
• Assists in preparing materials for investigator meetings, monitor workshops, and study manual.
• Communicates and coordinates with team members to ensure accurate and comprehensive completion of documents by Regulatory Affairs; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines.
• Interfaces with other cross functional groups to coordinate relevant and timely exchange of information / materials as assigned.
• Assist with data reconciliation, as required.
• Participate in the review of clinical data in the clinical database, data listings, and reports, as assigned.
• Update and maintain public clinical trial listings/postings (e.g., www.clinicaltrials.gov, EUDract registry, etc.).
• Assist with clinical trial insurance policies (includes obtaining and reviewing policies for new studies, tracking and renewing expiring insurance certificates, etc.).
• Prioritizes and plans work activities; Uses time efficiently to meet deadlines.
• May be assigned additional responsibilities based on study needs.

 

Qualifications:

Education

• Bachelor’s degree in a relevant scientific discipline

Experience

• 2+ years with biotechnology/pharmaceutical/clinical trial management experience. Global experience a plus.
• Familiarity with document filing/management in an eTMF environment Excellent communication and interpersonal skills
• Effective organizational skills and a high regard for attention to detail
• Ability to efficiently perform multiple tasks and manage changing priorities.
• Proficiency in Microsoft suite of products such as Word, Excel etc.

Travel Required: Up to 20%
]]> Tue, 03 Mar 2026 00:00:00 EST 0 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 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]]> Tue, 03 Mar 2026 00:00:00 EST 1
Job Details:
• Following Good Manufacturing Practices (GMPs) and applicable regulations from the Code of Federal Regulations (CFRs).
• Reporting any discrepancies to the Team Leader or Production Supervisor to ensure quality standards and safety.
• Ensuring quality & compliance through a Right First-Time mentality.
• Receiving and preparing components for use in manufacturing.
• Feeding components into equipment and performing sanitation activities.
• Documenting appropriate paperwork, understanding Overall Equipment Effectiveness (OEE)/performance metrics, and participating in daily performance meetings.
• Use of pallet jacks and manual wrapping of pallets.
• Use of computer systems to support material inventory and electronic batch record.
• Partnering with cross-functional teams to drive improvement opportunities.
• Ensuring components and products are available for continuous operation.?]]> Tue, 03 Mar 2026 00:00:00 EST 1
Key Accountabilities:
• Responsible for the Quality review and approval of engineering and validation documentation to support requirements Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ); validation master plans, risk assessments, calibration and periodic reviews, etc.
• Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices (cGMP) & supports validation.
• Support all aspects of the Validation Life Cycle from design through operation and improvements, and the revalidation program.
• Represent QA in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation)
• Create, review, and approve SOPs, Change Control and Corrective Action Preventive Action (CAPA) and additional documentation and quality systems such as SOPs, forms, reports, deviation, etc. as needed.
• Works directly with operating entities, with multiple functions, internal and external, to provide Quality validation support to assure requirements meet project expectation and meet local procedures and regulations.
• Interface with Manufacturing, Packaging, Engineering, MSAT, PD, and QA/QC departments to resolve process issues and implement changes.
• Identify, analyze, and manage risk through product life cycle with use of risk management tools.
• Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
• Participate in internal, client and/or regulatory audits.
• Work with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
• Establish, maintain, trend and report Quality KPI and metrics.
• Participate in Management Review, Quality Review Board Deviation Review Board and Change Review Board as required.
• Other tasks as assigned by Senior Manager of QA Operations.

Pay ranges between 35-40.85/hr based on experience ]]> Tue, 03 Mar 2026 00:00:00 EST 1
Key Job Duties and Responsibilities:
Inspection & Testing: Performs visual and physical inspections of raw materials, in-process components, and finished products to ensure they meet quality specifications. Uses precision measuring tools and lab equipment to verify product dimensions and performance.

Documentation & Compliance: Accurately maintains Lot History Records (LHR), batch records, and inspection logs in compliance with Good Documentation Practices (GDP) and FDA regulations.
Defect Management: Identifies, classifies, and reports defects. Manages non-conforming material by initiating Non-Conformance Reports (NCR) and assisting with investigations.

Process Control: Monitors production processes to ensure adherence to standard operating procedures (SOPs) and Good Manufacturing Practices (GMPs).
Equipment Maintenance: Calibrates, cleans, and performs routine maintenance on inspection and testing equipment to ensure accuracy.
Collaboration: Works with production and engineering teams to support quality improvements, provide feedback on product quality, and ensure regulatory compliance.

Key Competencies:
Attention to Detail: High level of accuracy in documentation and inspection.
Computer Literacy: Proficient in using software like SAP, POMS, or Laboratory Information Management Systems (LIMS).

Technical Knowledge: Understanding of ISO 13485 and FDA 21 CFR Part 820 regulations.

Communication: Ability to clearly report deviations and collaborate in a team environment.

Common Educational/Experience Requirements:
High school diploma or equivalent is required. Associates or Bachelors degree in a technical field preferred.

Previous experience in manufacturing, particularly in medical device, pharmaceutical, or similar regulated industries is highly desired. 1+ years of experience desired.

Pay ranges between 20-26/hr based on experience ]]> Tue, 03 Mar 2026 00:00:00 EST 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
]]> Tue, 03 Mar 2026 00:00:00 EST 1
In this position you will work alongside a cross functional team and with other Software Quality Engineers. Your primary responsibilities will be to develop, modify, apply, and maintain software quality documentation following operating methods, processes, and procedures. This will include evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.

Top 3 technical  skills that are required for the role:

1. Performing Software FMEA

2. Risk Management Planning and Reporting experience

3. Knowledge of IEC 62304

Education Required:

Requires a Baccalaureate degree

Years’ Experience Required:

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience 

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite (Boston)

What is your timeline for scheduling interviews? Immediate

What product line will this person support? Hugo


Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures. Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation. Defines appropriate measures to ensure product quality. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts. Reviews software systems design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable specifications, materials, tools, techniques, and methodologies. Provides or directs verification and validation of software system requirements, traceability, and testability.

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, 03 Mar 2026 00:00:00 EST 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

]]> Tue, 03 Mar 2026 00:00:00 EST 0 Job Title: EDC & IWRS Integration Specialist
Location: Remote (India-based)
Start Date: March, Immediate joiners preferred./

Role Context: This is a contract position supporting an established clinical systems team within a structured global clinical research environment. The focus is on technical expertise and hands-on integration experience.

Key Requirements
Experience Level: 4–6 years of relevant experience
Mandatory: Direct experience with IVR / IWRS integrations
Required Skills

• Strong understanding of EDC and IWRS system integrations
• Hands-on experience with Rave Web Services (RWS) integrations
• Working knowledge of RWS APIs, including API call types and system behavior
• Ability to analyze and troubleshoot ODM XML files
• Understanding of RWS response codes and common failure scenarios
• Experience interpreting and debugging API response messages

]]> Tue, 03 Mar 2026 00:00:00 EST 1 Join Our Team as an Aftermarket Service Engineer – Elevate Your Engineering Career!
 

Are you a proactive, detail-oriented engineer with a passion for high-precision testing and servicing within the cleanroom and containment industries? We’re seeking two talented Aftermarket Service Engineers to deliver exceptional on-site service, support critical testing processes, and help our clients maintain the highest standards of operational excellence. This is your chance to work in a dynamic, fast-paced environment with travel opportunities across the UK—and occasionally overseas—while making a tangible impact in cutting-edge industries.

What You’ll Do:

• Conduct on-site testing, calibration, and servicing of containment and cleanroom equipment, including airflow testing, DOP testing, particle counting, and filter integrity assessments.
• Maintain and calibrate test equipment, ensuring compliance with industry standards.
• Troubleshoot electrical and mechanical faults, supporting operational integrity.
• Compile detailed reports and documentation for each service visit.
• Promote additional service, upgrade, and spares opportunities.
• Travel extensively throughout the UK (and internationally as required), working independently and as part of a team to deliver scheduled and ad-hoc maintenance projects.
• Collaborate closely with clients, site personnel, and internal teams to ensure operational success and safety compliance.

What We Need From You:

Required Skills:

• Proven experience with airflow testing, DOP testing, particle testing, and filter integrity assessments.
• Strong electrical and mechanical troubleshooting skills.
• Excellent organizational skills and meticulous attention to detail.
• Ability to work independently with minimal supervision.
• Good communication skills for client interactions and reporting.
• Valid driving license and willingness to travel extensively.

Nice to Have Skills:

• Experience working within cleanrooms, GMP environments, or containment industries.
• Background in servicing or commissioning medical, pharmaceutical, or high-containment equipment.
• Knowledge of calibration procedures and test equipment maintenance.
• Basic knowledge of PLCs, HMIs, and automation systems.

Preferred Education & Experience:

• Engineering apprenticeship, HND/HNC qualification, or relevant technical training in instrumentation, testing, or engineering disciplines.
• Prior experience in airflow testing, particle counting, containment, or similar sectors.

Additional Requirements:

• Willingness to travel 90-100% of the time, including overnight stays.
• Experience or familiarity with GMP standards is advantageous.
• Must uphold strict health and safety standards, report issues proactively, and be adaptable to varying project demands.

Take the next step in your career today—apply now to join a forward-thinking company where your skills will be valued, and your growth supported!
]]> Tue, 03 Mar 2026 00:00:00 EST 1 Job Title: Clinical Data Management (CDM) Associate – Validation  
Location: Remote (India-based)
Start Date: March, Immediate joiners.
Role Context: This is a contract position within a global clinical research environment, focused on validation activities within Clinical Data Management. The role requires strong technical capability and independent execution.

Key Responsibilities

• Independently conduct validation testing for edit checks, SAS listings, transfer programs, and custom reports
• Perform QC for eCRFs and Time & Events
• Ensure documentation compliance and timely updates
• Review documentation prepared by junior team members
• Escalate issues appropriately to validation leadership
• Conduct quality reviews of testing activities
• Meet project timelines while adhering to SOPs
• Maintain effective communication across geographically distributed teams

Required Skills

• Strong understanding of CDMS databases
• Solid MS Excel skills
• Good understanding of clinical research and ICH-GCP guidelines
• Strong knowledge of CDM processes, particularly validation workflows
• Strong analytical skills and high attention to detail
• Ability to understand and test complex logic

Preferred

• Relevant certification (good to have)
• 5+ years of relevant CDM validation experience

]]> Tue, 03 Mar 2026 00:00:00 EST 1 Target PR Range: 79-89/hr
*Depending on experience

Overview
Join our International Customer Excellence PMO group supporting high-impact global business transformation, strategic programs, and product launches within a matrixed pharmaceutical environment. We’re seeking contractors who thrive in dynamic settings, partner well across regions and functions, and help drive operational excellence aligned with organizational growth.

Key Responsibilities:
• Execute PMO activities to enable aligned project delivery across multiple functions, regions, and affiliates
• Support and maintain industry-standard PMO processes, tools, and reporting methodologies to ensure consistency, governance, and transparency
• Collaborate with international commercial and marketing teams to facilitate smooth communication, touchpoints, and delivery of key initiatives
• Assist senior PMO leads and project managers in risk management, resource planning, and performance tracking for initiatives spanning business transformation, strategy, and launches
• Prepare project status reports, summaries, and presentations for stakeholders and sponsors
• Help coordinate cross-functional meetings and workshops (e.g., town halls, council sessions), ensuring logistical and content alignment

Skills, Experience, Education:
• Bachelor’s degree required
• Minimum 3 years’ experience managing matrixed, cross-functional, or global projects/programs (business transformation, strategic initiatives, product launch, etc.)
• Strong written and verbal communication skills; English fluency required
• Ability to engage with diverse stakeholders and teams in a global environment
• Familiarity with PMO methodologies, tools, and frameworks (specific certifications/tools TBD)
• Pharmaceutical industry exposure a plus but not required

Preferred:
• Project management certifications advantageous
• Direct experience supporting international initiatives or teams
• Experience preparing project reporting for senior management
]]> Tue, 03 Mar 2026 00:00:00 EST 1 Join a dynamic and innovative team as a Business Analyst - a pivotal role offering high visibility and strategic influence within a leading organization in the biotech/pharma sector. This position provides a unique opportunity to support executive decision-making, drive financial excellence, and collaborate across functions in a fast-paced environment. Based near Milan, you’ll work directly with senior leadership, gaining invaluable exposure and shaping key business initiatives.

Required Skills:

• Minimum 2 years of experience as a Business Analyst and/or Business Controller, preferably within biotech, pharma, healthcare, or regulated industries
• Strong proficiency in Excel and PowerPoint, with proven experience in financial modeling and analytical reporting
• Excellent problem-solving capabilities and keen attention to detail
• Fluent in English and Italian.
• Ability to work independently with minimal supervision
• Exceptional organizational and time management skills
• Strong interpersonal and influencing skills to foster collaboration and gain consensus across teams
• Knowledge of contract evaluation, cost/benefit analysis, budgeting, and forecasting

Nice to Have Skills:

• Experience within biotech, pharmaceuticals, or healthcare sectors
• Familiarity with strategic business design, simulation modeling, dashboards, and analytics tools
• Previous engagement in M&A, licensing negotiations, or project coordination at the executive level
• Skills in MS Visio, MS Project, or similar project management tools

Preferred Education and Experience:

• Bachelor’s Degree in Information Systems, Engineering, Business, Data Science, or related fields
• At least 2 years of experience in data analytics and financial control roles within regulated environments
• Proven ability to build credible relationships with C-suite and senior management

Other Requirements:

• Fluency in English and Italian
• Willingness to be in the office approximately four days a week for maximum visibility and team collaboration

If you’re ready to make a meaningful impact in a growing, forward-thinking organization and meet these criteria, we encourage you to apply now. Take the next step in your career by joining a team where your expertise will truly matter.
]]> Tue, 03 Mar 2026 00:00:00 EST 1 Job Summary:
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities: 
 • Designs experimental protocols with minimal supervision.
• Executes bench experiments; makes detailed and general observations and analyzes data.
• Prepares technical reports, summaries and quantitative analyses.
• Maintains complete and accurate records.
• Normally receives general directions on routine work and detailed directions on new assignments.
• Makes suggestions to improve work processes and laboratory environment.
• Assists in identifying and reducing to practice patentable inventions.
• Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for
obtaining solutions.
• May participate in cross functional technical teams such as a failure investigation team.
• Works well in a team environment by being a productive project team member, suggesting creative solutions
to problems and providing input to project planning.
• Trains others in areas of expertise.
• Troubleshoots problems and institutes corrective action.
• Prepares and presents experimental procedures and results in group and project teams.
• Monitors work to ensure quality, and continuously promote Quality First Time.
• Other duties as assigned by management.

Qualifications: 
Bachelor's Degree degree in Science
2 years relevant job experience.

Are equivalencies acceptable?
No

Knowledge, Skills and Abilities 
Knows basic and a range of specialized laboratory techniques.
• Capable with searching scientific literature to gain information about specific topics
• Skilled with use of word processing, spreadsheets, graphical and presentation software applications.

The max pay rate is 27/hr for this postion 
]]> Mon, 02 Mar 2026 00:00:00 EST 1 Wir suchen einen Procurement Manager (m/w/d) für unser wachsendes Business im Bereich Automatisierung. In dieser Schlüsselrolle treiben Sie strategische Einkaufsinitiativen voran, managen Lieferantenbeziehungen und wirken aktiv an internationalen Projekten mit.

Ihre Aufgaben

• Verantwortung für strategische Einkaufsinitiativen zur Maximierung des Geschäftsnutzens.
• Entwicklung und Umsetzung von Supplier Relationship Management sowie mehrjährigen Wertschöpfungsplänen.
• Steuerung von Lieferantenprojekten und Eskalationsmanagement bei kritischen Themen (Lieferung, Kosten, Qualität).
• Unterstützung bei der Implementierung von Warengruppenstrategien inkl. Projektmanagement, Stakeholder-Kommunikation und Reporting.
• Durchführung von Marktanalysen, Lieferantenauswahl, Risikobewertung, Verhandlungen und Vertragsabschlüssen.
• Erreichung von Kosteneinsparungen, Cashflow-Optimierung und Risikominimierung gemäß strategischen Unternehmenszielen.

---

Ihr Profil

• Abgeschlossenes Studium (Bachelor oder höher) in Betriebswirtschaft, Ingenieurwesen oder vergleichbarer Fachrichtung.
• 7–10 Jahre Erfahrung im Bereich Einkauf und Lieferantenmanagement.
• Mindestens 3 Jahre internationale Projektmanagement-Erfahrung.
• Verhandlungssichere Deutschkenntnisse (Muttersprache) und fließendes Englisch.
• Reisebereitschaft (gelegentlich).
• Ausgeprägte Projektmanagement-Skills inkl. Governance (Planung & Monitoring).
• Starke Kommunikations- und Präsentationsfähigkeiten sowie Verhandlungskompetenz.
• Erfolgreiche Umsetzung strategischer Einkaufsinitiativen mit messbarem Geschäftserfolg.
• Idealerweise Kenntnisse in elektromechanischen Warengruppen und Markttrends.

]]> Mon, 02 Mar 2026 00:00:00 EST 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.
  

]]> 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
The role acts as the project manager and coordinator supporting the Site IT lead in the delivery of complex IT-OT infrastructure projects as well as smaller IT-OT infrastructure requests. The successful candidate will be responsible for planning, executing, and delivering projects and infrastructure requests on time, within scope, and on budget, while ensuring alignment with business objectives and technical requirements. The role will primarily interact with global IT infrastructure, local site stakeholder, and external IT service providers for any infrastructure related matters (data center, network, end-user client management and support).

In addition, the role will need to strongly cooperate with following partners to ensure operational efficiency and IT services delivery compliance:

• IT-OT Security & Compliance team
• Infrastructure Architecture
• Site and IT PMO
• Manage site infrastructure demand and project portfolio - prioritize infrastructure (IT and OT) demand from site as well as global infrastructure and security initiatives and change requests, plan, prioritize and coordinate those activities for delivery with IT infrastructure and local teams according to establish governance and processes
• Attend Infrastructure CAB meetings as representative of the site - Ensure adequate scope, impact assessment and prioritization for changes are defined and communicated within the region


• Project Planning & Execution:
o Develop project charters, including scope, objectives, timelines, resources, and budget.
o Lead project teams to deliver infrastructure solutions, including servers, networks, storage, and cloud technologies.
o Coordinate and oversee all phases of project delivery, including design, implementation, testing, and handover to operations.
• Stakeholder Management for any IT infrastructure related matters (data center, network, end-user client management and support, etc...)
o Act as primary contact between site IT leads, infrastructure CoE, local OT team, and IT Service providers
o Communicate project status, risks, and issues effectively to all stakeholders.
o Facilitate meetings, including kick-off, status, and review meetings.


• Budget & Cost Management:
o Develop and manage project budgets, ensuring financial controls are in place.
o Monitor project expenses and report on cost variances.
• Documentation & Reporting:
o Maintain detailed project documentation, including project plans, status reports, and post-implementation reviews.
o Report on project progress, KPIs, and outcomes to senior management.

Pay ranges between 75-82/hr based on experience ]]> 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

---

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 We are seeking an experienced EHS Specialist to support a major infrastructure project, ensuring that all health, safety and environmental standards are implemented, monitored and continuously improved. This role requires deep experience in construction or infrastructure environments, strong stakeholder management and the ability to influence safety culture on site.

This is a part?time position (8 hours per week) over a 12?month duration.
What You’ll Do

• Implement project?specific EHS processes and procedures in alignment with the project’s safety plan (PSS).
• Maintain, update and improve the PSS and other related documentation as required.
• Lead and participate in safety walks, audits, inspections and incident investigations.
• Facilitate and chair safety meetings with subcontractors, including preparation of minutes of meeting.
• Participate in coordination boards, look?ahead discussions and permit meetings, providing guidance on safety requirements.
• Advise internal and external stakeholders on health, safety and security needs throughout the project lifecycle.
• Supervise HSE performance during ongoing site activities, including occasional nights or weekends when needed.
• Develop and deliver communication materials on operational safety topics.
• Conduct training and awareness sessions for colleagues on key health and safety aspects.
• Escalate issues to management where appropriate and ensure timely follow?through.
• Promote and model a strong safety culture, ensuring compliance with all regulations and site requirements.
• Act as the point of contact for safety?related authorities.
• Serve as deputy to the EHS Lead when required.

What You Bring

• Approximately 10 years’ experience in EHS roles within infrastructure or large?scale construction projects.
• Strong knowledge of project?based safety systems and regulatory frameworks.
• Proven experience managing safety processes in complex, multi?stakeholder environments.
• Ability to influence behaviours and foster a proactive safety culture.
• Confident communicator capable of leading meetings, training sessions and cross?functional safety activities.
• Comfortable supervising site activities and responding to safety needs outside regular working hours when required.

]]> Mon, 02 Mar 2026 00:00:00 EST 1 The ideal candidate brings strong technical fundamentals—particularly in hydrogen peroxide vapour (HPV) technology, electro?mechanical systems and PLC?controlled equipment—alongside the ability to lead a multi?disciplinary team and collaborate effectively in a regional and global environment.
What You’ll Do

• Lead customer service and technical service operations across the region, ensuring a consistent and exceptional customer experience.
• Oversee installation, qualification, validation, service, repair and calibration activities for complex equipment.
• Provide technical support and equipment recommendations during customer discussions and sales meetings.
• Manage customer escalations, claims and complex service cases as the central point of coordination.
• Lead, coach and develop a team of service engineers, technicians (5–6) and a customer?service representative.
• Work with global operations and training teams to embed best practices and ensure the local team maintains required certifications.
• Plan and optimise service resources to meet customer needs, safety expectations and business targets.
• Promote high standards in field service execution, quality, safety and customer communication.
• Use digital tools to enhance service effectiveness, support field activities and strengthen operational performance.
• Oversee local H?O? filling operations and liaise with global supply?chain counterparts.
• Drive continuous improvement using customer feedback, operational data and field insights.

What You Bring

• Bachelor’s degree in business, engineering or a related technical discipline.
• 8–10+ years of experience in customer service operations, technical service or field service leadership.
• Proven leadership experience managing diverse technical teams in regulated or equipment?heavy environments.
• Strong technical fundamentals, including knowledge of HPV systems, PLCs, HMIs, control systems and electro?mechanical equipment.
• Experience providing technical recommendations to customers and supporting sales engagements.
• Strong communication, collaboration and decision?making abilities with comfort working in a global matrix structure.
• Experience with calibration, pressure testing or HEPA filter testing is an advantage.

]]> 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 Pay 55-70/h depending on experience

Top 3 technical  skills that are required for the role:

1. Demonstrated experience in validations IQ, OQ, PQ

2. Demonstrated experience with running medium to large capital projects

3. Experience with statistical methods

Education Required: Baccalaureate degree preferably in engineering (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)

Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. 

Will the contractor be working 40 hours a week? If not, weekly estimate?

40 hours a week possible overtime needed.

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?

Onsite

What is your timeline for scheduling interviews?

Would like to start interviews by early March.

What product line will this person support?

They will support the Electron Beam that cures the gel used as a part of our PolyHesive Pad production.

 

Responsibilities may include the following and other duties may be assigned.

• Provide engineering support for our electron beam manufacturing line ensuring optimal operation, performance, and adherence to policy.
• Manage changing priorities and respond quickly to challenges in a fast-paced, dynamic manufacturing environment.
• Design, develop, and improve manufacturing processes, procedures, and production layouts for product assembly, equipment installation, and material handling.
• Work closely with R&D, Quality, and other cross-functional teams to drive the integration of new technologies, process changes, and continuous improvements.
• Validate new components, systems, and process changes to ensure product performance, quality, and efficiency.
• 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.
• Adapts machine or equipment design to factory and production conditions.
• Ensure all manufacturing processes, equipment, and procedures comply with industry regulations and standards, with a focus on maintaining safety and product integrity.
• Mentor and coach junior engineers and team members, providing guidance in design, troubleshooting, and process optimization.

 

Required Knowledge and 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 of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

·         Practical knowledge of project management.

·         Strong attention to detail.

·         Strong written and verbal communication skills.

·         Strong technical aptitude with ability to troubleshoot complex interconnected systems, interpret schematics, and offer effective solutions.

·         Demonstrated experience in validation.

·         Ability to manage changing priorities and maintain productivity in a high-paced, evolving environment.

·         Experience with statistical methods preferred.

·         Experience in manufacturing and/or regulated industry strongly preferred.

·         Experience with running medium to large capital projects preferred.
]]> Mon, 02 Mar 2026 00:00:00 EST 1 Job Summary: 
Responsible for conducting research, development and manufacturing laboratory experimentation and other scientific activities to support projects. Exercises technical expertise and discretion in the design, execution and interpretation of experiments that contribute to project strategies. Prepares technical reports, summaries, protocols and quantitative analyses. Presents and discusses results of experiments within department and project team. Maintains high level of professional expertise through familiarity with scientific literature and
may participate in conferences and professional societies. Follows company policies and procedures for GMP, GLP, Design Control and others as appropriate. Maintains complete and accurate laboratory documentation and electronic files. May act as principal investigator in conducting own experiments.

Responsibilities:
• Designs a wide range of experimental protocols.
• Executes bench experiments; makes detailed and general observations and analyzes data.
• Prepares technical reports, summaries and quantitative analyses.
• Maintains complete and accurate records.
• Normally receives general directions on routine and new assignments.
• Identifies and implements improvements to work processes and laboratory environment.
• Recognized expert for area of expertise.
• Recognizes and documents activities for publication and/or patent potential.
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Participates in cross functional technical teams such as a failure investigation or core team.
• Works well in a team environment by being a productive project team member, suggesting creative solutions to problems and providing input to project planning.
• Establishes interfaces across other organizational groups.
• Trains others in areas of expertise.
• Troubleshoots problems and institutes corrective action.
• Prepares and presents experimental procedures and results in group and project teams.
• Monitors work to ensure quality, and continuously promote Quality First Time.
• Other duties as assigned by management.

Education: 
Bachelor's Degree in Science. (Required)

Experience:
4 years of relevant job experience. (Required)

Are equivalencies acceptable?
No

Knowledge, Skills and Abilities:
Knows wide range of experimental techniques and skilled in their applications. (Required)
• Capable with searching scientific literature to gain general and specific information. (Required)
•Skilled with use of word processing, spreadsheets, graphical and presentation software applications. (Required)

Pay ranges between $30-34/hr based on experience 
]]> 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 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

---

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

---

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
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]]> Mon, 02 Mar 2026 00:00:00 EST 1 Test Technician – Robotic Platforms

 

As a Test Technician, you’ll be in driving projects through the product verification process for Hugo RAS, using your results driven work ethic, collaborative spirit, and solution facilitation skills. You will be supporting various systems engineering test activities such as integration, verification, reliability testing, analysis, hardware and software troubleshooting, and more. 

 

Careers that Change Lives

 

Our space, the medical device and healthcare industry, is rapidly changing. It always has been that way. With remote monitoring, wearables, robotics, AR/VR, telemedicine, and much more, agility and responsiveness are key to our success. Experience what it’s like to work at a company with an exciting product pipeline full of patented inventions driving innovation in the healthcare space.

 

A Day in the Life

·         Execute test methods and simulated procedures on the robotic-assisted surgery system. Makes and records observations; performs simple calculations; and collects and prepares data for evaluation.

·         Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.

·         Document system performance and usage, and communicate hardware or software issues.

·         Perform simulated bedside assist functions including positioning the system components and introduction and removal of test materials.

·         Perform manual setup and tear down activities, including cleaning of all equipment surfaces, and orienting medical equipment for daily storage and transport within the lab space.

·         Conducts laboratory support functions such as inventory and maintenance on supplies and equipment.

·         Perform periodic workflows test methods including manually transporting equipment throughout the facility, taking measurements to evaluate system functional performance over time, and emergency simulation or response activities.

·         Execute batches of repetitive cycling of ergonomic adjustments and interactions with user interfaces including buttons, switches, touch screens, and medical equipment control surfaces.

·         Performs technical procedures in one or more of the following areas: Production, Research and Development, Quality Control/Assurance, and/or Compliance/Environmental.

·         Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems . May be required to highlight areas of concerns/problems in own job area.

Must Have: Minimum Requirements

Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.

Nice to Have

• 3+ years of technician experience in the medical device or regulated industry
• Ability to create accurate diagrams and document equipment configurations.
• Ability to quickly learn new or unfamiliar technology and products.
• Fundamental understanding of computers and basic experience with networking and upgrades.
• Basic knowledge in circuit boards and electronics.
• Understanding of hardware and software interactions, communications, and troubleshooting.
• Ability to diagnose system failures, isolate, reset, or replace faulty components.
• Experience with purchasing, tracking, and receiving equipment.
• Experience assembling office equipment, electronic equipment, electronic assemblies.
• Experience leading and seeking guidance to complete laboratory maintenance needs.
• Experience setting, running, and execution of test procedures.

]]> 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

Sustain products in production by addressing scrap issues, specification or safety concerns, efficiency improvements, and executing required document updates.

Develop accurate and complete product, component, and assembly specifications—including item masters and bills of material—using customer drawings/specs and this clients quality requirements for new or transfer products.

Collaborate with Production, Quality Engineering, Program Management, Project Engineering, and Process Engineering to conceptualize, research, and implement new ideas, processes, and technologies.

Provide guidance for quotes and new product development, especially when post-mold processing is involved.

Develop and implement engineered solutions in production to address identified nonconformances.

Write and execute comprehensive qualifications/validations for processes outside standard molding, including risk assessments.

Partner with internal teams to create and implement procedures that improve this clients product quality.

Work collaboratively across the organization to identify solutions and manage complex tasks.

Provide training and guidance to manufacturing personnel as needed.

Offer training and insights to engineers to support their development and company improvement.

Perform other duties as assigned by engineering or plant management.

Manage and maintain a working capacity plan for analysis and strategic planning.

Recommend future capital expenditures to support new programs and launches.

Create capacity plans and provide direction on capital requirements for current and future work. TOP 5 MUST-HAVE SKILLS

• Education / Experience: Engineering degree or 4+ years relevant experience; 2–3 years plastic injection molding experience.
• Technical: Strong understanding of automation equipment/systems and GD&T.
• Quality / Regulatory: Knowledge of ISO/FDA regulations, GMPs; ability to write process FMEAs & validations.
• Documentation: Ability to create specifications, BOMs, item masters, and capacity plans.
• Soft Skills: Communication, collaboration, ability to train personnel.

 ]]> Mon, 02 Mar 2026 00:00:00 EST 0 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.
  

]]> Mon, 02 Mar 2026 00:00:00 EST 1
• Perform 6S and stock each suite daily, clean soiled parts daily.
• Determine production needs for autoclaved assembles and deliver to suites.
• Perform daily and weekly maintenance activities on analytical equipment.
• Perform weekly and monthly cleans of inoculum rooms.
• Report all activities 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
• Prepare materials for transport and delivery to manufacturing suites. Perform material movements into, out of, and across the production areas.
• Maintain facility and equipment through routine cleaning and sanitization.
• Administrative tasks - attending suite shift exchange, meetings, sending/receiving emails, participating in projects, perform other duties as assigned.
• Perform other duties as assigned.

The max pay rate is $23.25/hr for this position ]]> Mon, 02 Mar 2026 00:00:00 EST 1 We’re partnering with a leading life sciences organisation to recruit a Business Support Manager who will play a pivotal role within the office of a senior scientific leader. This is a high?impact position that blends executive support, strategic coordination, and operational delivery — ideal for someone who enjoys work that goes far beyond traditional EA responsibilities.

You’ll act as a trusted partner, ensuring priorities run smoothly, communication flows effectively, and key initiatives move forward with pace and clarity.

---

What You’ll Do Executive & Strategic Support

• Manage a complex forward-looking agenda, ensuring priorities, commitments, and deadlines are well?structured and achievable.
• Prepare high?quality briefing packs, board materials, written communications, speeches, and presentations.
• Attend meetings on behalf of the scientific leadership office where required, ensuring actions and follow?ups are tracked and delivered.
• Drive business planning processes, leadership meeting rhythms, and internal projects.
• Conduct research, prepare insights, and support strategic decision?making through concise analysis and recommendations.

Operational & Project Coordination

• Oversee the day?to?day flow of information and communication within the scientific leadership office.
• Manage inbox communications, triaging, prioritising, and drafting responses with discretion and accuracy.
• Coordinate regular meetings with senior leaders, ensuring agendas, materials, and actions support effective collaboration.
• Support cross?functional projects and ensure execution of key plans and initiatives.

Representation & Stakeholder Engagement

• Engage confidently with senior internal and external stakeholders, ensuring strong and trusted relationships.
• Handle sensitive matters with professionalism, integrity, and sound judgement.
• Represent the scientific leadership office as needed and provide clear, accurate reporting and follow-through.

---

What You Bring Essential Experience

• Significant experience supporting senior executives, ideally within life sciences, R&D, biotech, or a comparable scientific environment.
• Understanding of life sciences, lab operations, or R&D organisations — gained through education or work experience.
• Strong background drafting board papers, briefing notes, and executive-level communications.
• Experience navigating complex organisations; exposure to non-profits or multi-stakeholder environments is a plus.
• Excellent analytical skills and the ability to summarise complex information clearly and persuasively.
• High-level organisational skills, meticulous attention to detail, and strong prioritisation capability.
• Advanced interpersonal skills and emotional intelligence — able to collaborate, influence, and build trust across senior levels.
• Strong project coordination experience with confidence managing multiple streams simultaneously.
• Advanced Microsoft Office skills plus strong capability with SharePoint and digital/AI-enabled tools.

Personal Attributes

• Mature judgement, discretion, and integrity — comfortable handling sensitive and confidential matters.
• Proactive, resourceful, and solutions?driven; able to anticipate needs ahead of time.
• Calm under pressure, adaptable, and resilient in fast-moving environments.
• Professional, positive, and confident engaging with diverse senior stakeholders.
• Able to respond quickly and appropriately to rapidly evolving situations.

]]> Mon, 02 Mar 2026 00:00:00 EST 1 Manager, Medical Advisory
Position Overview
The Medical Advisor serves as an internal scientific authority for a designated product or therapeutic area. This role is responsible for shaping and executing the Medical Affairs strategy and works in close partnership with Marketing and Market Access to ensure the product’s scientific value is accurately and appropriately communicated within the Japanese market.
Key Responsibilities
Medical Strategy

• 
  Develop and implement the annual Medical Plan, including publication planning and evidence-generation initiatives.
  

Cross-Functional Leadership

• 
  Act as the scientific lead within the Brand Team, reviewing promotional materials to ensure medical accuracy and compliance with applicable local regulations.
  

Advisory Boards

• 
  Plan and facilitate Expert Advisory Board meetings with key external specialists in Japan.
  

Evidence Generation

• 
  Design and oversee Phase IV (post-marketing) studies and Real-World Evidence (RWE) projects relevant to the Japanese patient population.
  

Training and Education

• 
  Deliver advanced scientific and therapeutic-area training to Medical Science Liaisons (MSLs) and Sales teams.
  

Qualifications
Education

• 
  MD, or PhD/PharmD/Master’s degree with substantial pharmaceutical or biotech industry experience.
  

Language Skills

• 
  Native-level Japanese and high-level business English required for frequent interaction with global and regional teams.
  

Experience

• 
  Minimum of 3 years of experience in Medical Affairs or Clinical Development preferred.
  
• 
  Background in oncology is desirable, particularly experience related to colorectal or bladder cancer.
  

Compliance Knowledge

• 
  Strong understanding of Japanese compliance standards, including relevant industry codes and Fair Trade Council (FTC) regulations.
  

]]> Sun, 01 Mar 2026 00:00:00 EST 1 Job Title: Regulatory Affairs Associate
Location: Japan

Role Overview

A life sciences organisation is seeking a Regulatory Affairs Associate to provide hands-on administrative and documentation support to the Regulatory Affairs function in Japan. This role is well suited to a detail-oriented professional with strong bilingual documentation skills who is comfortable working with English and Japanese regulatory materials.

The position plays a key supporting role in regulatory project coordination, documentation quality, and submission readiness, working closely with senior regulatory leadership and cross-functional teams.

Key Responsibilities

• 
  Provide day-to-day administrative and coordination support for regulatory projects, including responding to internal and external queries
  
• 
  Format regulatory documents in both English and Japanese in line with established templates, style guides, and regulatory standards
  
• 
  Support preparation, review, and quality control of XML files for regulatory submissions
  
• 
  Assist with document uploads and submissions via the PMDA Gateway in accordance with internal procedures and regulatory requirements
  
• 
  Prepare, maintain, and archive regulatory contact reports to ensure accurate documentation and traceability of communications
  
• 
  Draft clear and accurate meeting minutes in both English and Japanese, capturing key discussions, decisions, and action items
  
• 
  Maintain organised records of regulatory documentation and correspondence with health authorities
  
• 
  Perform quality checks on regulatory documents, ensuring grammatical accuracy, consistency, and uniform formatting across English and Japanese materials
  

Candidate Profile

• 
  Strong English reading, writing, and comprehension skills (basic spoken communication acceptable)
  
• 
  Native-level or highly proficient Japanese
  
• 
  Advanced Microsoft Word formatting capabilities
  
• 
  Experience performing quality control (QC) of bilingual (English/Japanese) documentation
  
• 
  Ability to review, refine, and improve machine-translated regulatory texts
  
• 
  High attention to detail with strong organisational and critical-thinking skills
  
• 
  Comfortable managing multiple tasks and working across functions in a regulated environment
  

Reporting & Collaboration

• 
  Reports directly to senior Regulatory Affairs leadership in Japan
  
• 
  Regular interaction with cross-functional teams to support interconnected regulatory and operational projects
  

]]> Sun, 01 Mar 2026 00:00:00 EST 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.
]]> Fri, 27 Feb 2026 00:00:00 EST 1 *depending on exp

Summary:
Delivers service and support to our customers which includes Preventive Maintenance of and/or Multivendor Products. This support will include troubleshooting and repair of minor issues related to maintenance requirements, post maintenance testing and calibration. Represents the face of  to the customer and drives best-in-class customer service, responsiveness and professionalism in all customer interactions.

Responsibilities:
• Provide scheduled preventative maintenance for contract customer
• Drive toward zero service recalls
• Complete assigned preventive maintenance calls at customer site within prescribed time frame and established performance standards
• Demonstrate knowledge of and adherence to service agreement provisions to provide adequate billing information to the customer
• Educate and promote the purchase of training, support, software, laboratory services products, consumables and field installed computer hardware/software upgrades
• Maintain updated documentation around dispatch, inventory and service support functions of the job
• Perform timely uploads and downloads of required data to ensure the integrity of service system(s)
• Accountable for assigned company assets to include: Tools, test equipment (MTE), telecommunication equipment, assigned service parts inventory, etc.
• Manage appropriate levels of inventory to ensure adequate supply and records are maintained
• Proactively develop technical and soft skills to maintain and enhance value proposition to the customer
• Display exceptional written and verbal communication skills and actively interface with peers and customers
• Develop organization awareness of other functional groups and product lines to direct customers or others to appropriate resources
• Seek higher level certification through participation in company sponsored training & development offerings
• Complete all administrative tasks to include but not limited to time reporting, LMS trainings, etc.
• Ability to travel by air, vehicle and/or other means of transportation as business requires
• Must have a valid driver’s license; While performing the duties of this job, the employee must safely operate a motor vehicle at all times
Basic Qualifications:
• Associate degree in Applied Science, Biology, Chemistry, Electronics, Mathematics, Engineering, Information Technology or related discipline including military experience.
Preferred Requirements:
• Associate’s degree
• Experience in HVAC, refrigeration and facilities maintenance is a plus
• Experience using Microsoft 365
• Exposure to analytical equipment and/or lab environment
• Knowledge of laboratory safety practices
• Certification of company training on equipment
• Strong interpersonal skills; team player with customer satisfaction focus
• Ability to follow written and verbal directions, read and understand technical bulletins and service manuals, work under time constraints, maintain alertness and concentration, work safely with potential electrical, chemical, radiologic, and biologic hazards using universal precautions
• Ability to communicate clearly and effectively with peers, managers, customers and other technical support professionals is critical to successful performance in this role
• requires
• The physical demands defined are representative of those that must be met by an employee to successfully perform the essential functions of this job: Regularly be required to walk, stand, sit and talk or hear; to use hands to finger, handle, feel or operate objects, tools, or controls; and reach with hands and arms. Occasionally required to climb or balance; stoop, kneel, crouch, or crawl. Frequently lift and/or move up to 50 pounds, and occasionally lift or move weights up to 100 pounds. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.

Must haves:
Tech background
Someone Tech-saavy
Fast learner who is adaptable

Nice to haves:
Previously background in a similar role.
Lab Bench experience (processing chemist or Sample processor) typically transitions well.

There is a possibility for full time conversation based on the performance.]]> Fri, 27 Feb 2026 00:00:00 EST 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]]> Fri, 27 Feb 2026 00:00:00 EST 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.
]]> Fri, 27 Feb 2026 00:00:00 EST 1 HM's Top Needs:

1. Ability handling blood (preferably in large volumes)
2. Basic wet lab skills
3. Proficiency in Microsoft Word and Excel

Education Required: High School Diploma, or Associate’s Degree (Bachelor’s degree would be overqualified and therefore, not be considered)

Years experience required: 1+ years

This position requires execution of duties in an animal/human blood lab using chemical, biological, electronic, mechanical, electromechanical and/or optical systems to assess the performance/interaction of medical devices with blood and/or equivalent test media in support of the development of new products and sustain the performance of released products. Responsibilities may include the following and other duties may be assigned. Performs a variety of technical procedures such as preparing routine solutions and reagents and performing routine reactions. Testing includes preparation of devices in perfusion circuits, circulating blood/test fluid through test circuits, and sampling blood/fluid at various time points. Makes and records observations; performs simple calculations; and collects and prepares data for evaluation. Conducts laboratory support functions such as stocking and distributing supplies and equipment; arranging and dismantling apparatus; and collecting, washing, and storing labware. Performs technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements. May analyze biological and chemical samples. Performs technical procedures in one or more of the following areas: Production, Research and Development, Quality Control/Assurance, and/or Compliance/Environmental.

TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on blood-contacting components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor, working under moderate supervision . Performs tests, interprets data and develops reports.

Organizational Impact: Performs intermediate technical activities requiring judgment and decisionmaking . Work consists of technical tasks that are typically routine.

Innovation and Complexity: Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems . May be required to highlight areas of concerns/problems in own job area.

Communication and Influence: Communicates typically with internal contacts . Obtains and provides technical information requiring some explanation or interpretation .

Leadership and Talent Management: May provide guidance and assistance to new or entry level employees.

Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.
]]> Fri, 27 Feb 2026 00:00:00 EST 1 *depending on exp

Ideal candidate is an Automation Technician (2 years) with strong hands-on PLC troubleshooting skills, ladder logic reading, HMI familiarity, and packaging equipment experience. Able to collaborate with mechanical techs, and adept at diagnosing electrical/automation issues in a GMP manufacturing environment. Industry background is flexible; key requirement is practical automation experience. Strong communication and problem-solving skills are essential.

In this role, you will provide technical engineering support on all system/equipment optimization strategies, upgrades, replacements, and modifications. You will evaluate and determine if utility systems, process maintenance, instrumentation/ calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area in Non-Standard Shifts structure.

Take part in the coordination of tech support on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.

Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
Support cGMP validation of equipment and processes.
Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans, and policies.
Investigate complex issues or problems through the mentorship of experienced staff.
Assist the team with maintaining an up-to-date working spare parts inventory system for equipment/systems.
Evaluate the current maintenance procedures and assist in the changes to optimize the maintenance program troubleshoot and repair equipment/system failures.
Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and HVAC P&ID's.
Support Operations using Current Good Manufacturing Practices (cGMP).
Support Operations in non-standard shifts that include weekends and/or holidays as determined by the business.]]> Fri, 27 Feb 2026 00:00:00 EST 1 About the role

The Validations Contractor – GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance, will be responsible for ensuring the compliant onboarding, qualification, and validation of equipment, instruments, and computerized systems against corporate procedures, and applicable GMP national, international, and state regulations. Acting as a key QA partner to technical and operational teams, this role will provide expert oversight and quality support throughout the lifecycle of validation activities, from planning and development through execution and final approval. This role will assist in the management of AskBio’s Quality Management System (QMS) and will strongly support AskBio’s Culture of Quality. The position will be based at our headquarters facility in RTP, NC with no travel expected.

Job Responsibilities

· Work alongside department customers on development, implementation, and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding.

· Provide timely quality support and thorough reviews and approvals of various records including, but not limited to; equipment and computer system qualification and validation documents, SOPs, Change Controls, non-conformities, Deviations and Corrective Action/Preventive Action (CAPAs).

· Ensure QA related activities are performed within the associated project timeline. Effectively escalate concerns to area and project management.

· Report on applicable key metrics to drive continuous improvement in compliance.

· Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues. Effectively collaborate in team

environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities.

· Maintain Quality Systems in support of AskBio’s QMS and GMPs, including:

o Support equipment and computer system qualification and validation activities and vendor management program.

o Review and approve SOP drafts and revisions.

o Support, review and approve assigned change control records.

· Communicate project status to stakeholders and escalate issues in a timely manner.

· Support ongoing Computerized Maintenance Management System records, including review and approval of work order records.

About you

· Bachelor’s degree in a scientific field.

· 5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing.

· Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.

· Strong technical understanding of equipment and system validation principles.

· Ability to author, review, and interpret Standard Operating Procedures (SOPs).

· Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.

· Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.

· Ability to manage workload effectively in order to meet project timelines.

· Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues across a dynamic GMP environment.

· Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
]]> Fri, 27 Feb 2026 00:00:00 EST 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)]]> Fri, 27 Feb 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 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

• 
  Candidates must be based within the UK, with London as the primary location
  
• 
  Regular regional travel is required, including overnight stays, attendance at industry events, and participation in internal meetings and training sessions
  
• 
  Occasional short-notice travel outside the assigned territory may be necessary
  
• 
  A full, valid driving licence is required
  

Key Responsibilities

• 
  Meet or exceed defined sales and utilization targets within the assigned territory, with a focus on increasing customer engagement and product usage
  
• 
  Deliver hands-on clinical education to customers across a range of aesthetic and energy-based treatments
  
• 
  Maintain consistent communication with existing clients to track performance and provide continuous clinical guidance and support
  
• 
  Develop strong customer relationships through onsite visits, delivering product education, clinical instruction, and staff presentations that support sales and marketing effectiveness
  
• 
  Advise customers on marketing approaches, including digital campaigns, website and microsite development, branding strategies, customer segmentation, and sales methodologies
  
• 
  Support and participate in regional events such as workshops, open days, and customer engagement activities within the territory
  
• 
  Conduct and support product demonstrations at industry events and internal training facilities
  
• 
  Collaborate closely with regional sales colleagues to identify opportunities and address customer needs
  
• 
  Manage administrative responsibilities, including CRM updates, business planning, expense reporting, forecasting, and regular account performance tracking
  
• 
  Contribute to cross-functional projects as required, ensuring tasks are completed on time and within budget
  
• 
  Undertake additional duties as reasonably required
  

Qualifications Essential Experience & Skills

• 
  Clinical or medical background, or demonstrable experience in a medical aesthetics environment
  
• 
  Degree-level education or equivalent professional experience
  
• 
  Certified and competent in operating laser and radiofrequency-based equipment on live patients
  
• 
  Background in aesthetics, beauty therapy, skin therapy, or a closely related field
  
• 
  Working knowledge of human and skin anatomy
  
• 
  Three to five years’ experience in a field-based sales, training, or marketing role
  
• 
  Strong communication skills, both verbal and written, with confidence presenting to groups
  
• 
  Proven ability to build credibility and influence customer decision-making
  
• 
  Adaptable, proactive, and able to manage multiple priorities in a fast-paced environment
  
• 
  Highly organized with strong attention to detail
  
• 
  Solid understanding of marketing principles, including traditional, digital, and in-practice strategies
  
• 
  Customer-focused, consultative approach with a strong service mindset
  

Desirable Experience

• 
  Previous experience working within an aesthetic or clinical practice
  
• 
  Exposure to the medical device or healthcare technology sector
  

 ]]> Thu, 26 Feb 2026 00:00:00 EST 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
  

]]> Thu, 26 Feb 2026 00:00:00 EST 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]]> Thu, 26 Feb 2026 00:00:00 EST 1 As a project manager you will plan, direct, and coordinate project activities for successful completion of all project deliverables to the business within established schedule, scope, financial and quality objectives. Projects will be for the Technical Service organization including launching service capabilities on new electronic products to our global service centers. The role will be onsite. 

Responsibilities:

• Manage project initiation/planning, execution, controlling, and closing phases.
• Manage large scale to enterprise-wide projects within program.
• Create and manage project schedule and action item trackers.
• Develop a high-level milestone plan for the program and manages program change in accordance with the change management plan to control scope, mitigate risks, quality, schedule, cost, and contracts.
• Establish and maintain program stakeholder relationships, expectations, and communications, both internal and external to the organization.
• Manage and control changes from original scope for every project.
• Serve as conduit between project/team members in all cross-functional groups.
• Perform other duties and responsibilities as assigned.

 

Preferred Qualifications:

• Degree in engineering, science or related is preferred.
• Regulated manufacturing environment is preferred.
• Experience with regulatory agency guidelines for medical device manufacturers is highly preferred.
• Project Management Professional (PMP) Certification is preferred.
• Proven track record in the management of multiple complex, large-scale projects with the ability to prioritize projects.
• Advanced skills in using and creating schedules in Microsoft Project.
• Ability to proactively escalate issues to appropriate levels of management in the organization.
• Must have excellent verbal and written communication skills.
• Ability to influence and build strong relationships is essential.
• Working experience managing resources and influencing others to action who are not direct reports.
• Possess and display sound judgment; initiative; flexibility and detail-orientation.
• Ability to adapt to new technologies and rapidly changing environment.
• Self-motivated and frequently demonstrates initiative by going “above and beyond” performing what is required for the position.
• Knowledge and work experience with Project budgets and financial management is a plus.

Pay $45-47/hr ]]> Thu, 26 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
• 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 24-27/hr based on experience ]]> Thu, 26 Feb 2026 00:00:00 EST 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

  ]]> Thu, 26 Feb 2026 00:00:00 EST 0
• 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]]> Thu, 26 Feb 2026 00:00:00 EST 1 Position Summary

The Sr. Clinical Research Associate (CRA) will manage clinical aspects of a larger-sized clinical study or, with supervision, assume some management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols.
 

• Local candidates, who can work in the SSF HQ office 2-3 days per week

Essential Duties And Responsibilities
 

• Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals.
• Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.
• Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed.
• Helps to oversee aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision.
• Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
• Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes.
• Participates in the review/ implementation of study design from an operations perspective and implements tactics at a site level.
• May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection.
• Supports Study Lead in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables.
• Participates in the development of critical study documents such as informed consent form templates, site management monitoring tools, FAQs, processes, and workflows.
• Participates in the development, distribution, review, and tracking of essential trial documents.
• Strives to ensure timelines and deliverables are met within budget.
• Participates in the development of and ensures compliance with the clinical monitoring plan; monitors as needed for training and quality assurance (QA) purposes.
• Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution.
• Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review.
• Liaises internally to forecast and monitor overall drug supply throughout the trial.
• Supports other study-wide activities as assigned - such as external vendors, sample handling, investigator payments, overall data quality, and overall central records quality.
• Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions.
• Contributes to the SOP review process and/or other Clinical Operations Initiatives
• Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits.
• Practices professionalism and integrity in all actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done.
   

TRAVEL

Up to 30%

Requirements

Education
 

• Bachelor’s degree in a relevant scientific discipline
• Minimum 3-4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting.
   

Experience
 

• Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting. Global experience a plus.
• A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.
• Self-motivated and able to motivate others.
• Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
• Strong attention to detail and ability to prioritize tasks to meet critical deadlines.
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools.
• Proficiency in Microsoft suite or products such as Word, Excel etc.

]]> Thu, 26 Feb 2026 00:00:00 EST 0
Job Details: To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Responsibilities include:? Monitors or follows established experimental design and protocols and performs routine tasks and studies to obtain reproducible and reliable results with limited supervision? Plans, monitors or conducts, analyzes and records experiments, and provides interpretation of data? Develops and implements new protocols with moderate review? Engages coworkers in scientific discussions? Communicates data and interpretation to work group? Skilled at developing systems to ensure quality data? Skilled and/or knowledgeable in the use of standard laboratory equipment and with one or more major laboratory instruments/techniques? Effectively trouble-shoots equipment and experimental difficulties? Contributes to internal/external reports, papers, presentations, regulatory documents, invention disclosure submissions and/or patents? Participates in department-wide support efforts such as safety, recruiting and committees? May train staff and/or supervise others? Coordinates and organizes resources needed to complete the task? Understands when to seek input and when to make independent judgments; Skills:; degree in Biology, Biochemistry or Analytical Chemistry or related field; experience in a Biopharmaceutical working environment]]> Thu, 26 Feb 2026 00:00:00 EST 1 *depending on experience

Position Overview
The San Diego Clinical and Specialty Services (CSS) Quality Assurance Specialist I supports clinical trial projects, ensuring all work is performed in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). They are responsible for implementing and maintaining quality assurance processes throughout the product lifecycle. This involves ensuring that all documentation is accurate, up-to-date, and properly maintained in accordance with regulatory requirements.

Education and Experience:
• Bachelor’s degree required or equivalent relevant work experience.
• 5-7 years of relevant work experience in a GMP environment, or comparable pharmaceutical knowledge and experience.
• JD Edwards or comparable ERP systems preferred.
• Minimum of 3 years of customer service experience.
• Proficient knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.).

Knowledge/Skills Requirements:
• Receives instruction, guidance and direction from others
• Uses existing procedures to solve routine problems
• Proactive to address work issues at the individual level
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
• Mathematical and scientific reasoning ability
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• Ability to work effectively under pressure to meet deadlines
• Sufficient skills and knowledge in the use of computers and associated computer technology (Microsoft Office Software = Outlook, Word, Excel, OneNote, PowerPoint)
• Computer technology relates to both the hardware and software used in performing common computing tasks. (JDE, TrackWise, Smartsheets).
• Proficient in Adobe Acrobat
• Proficiency in all QS I items
• Proficient in JDE
• Able to create Certificate of Analysis independently
• Inspection of bulk drug and finished product
• Adhere to GMP standards routinely with limited errors and limited guidance
• Able to help with investigations
• Able to communicate to other teams about requirements
• Perform effective rapid response
• Subject Matter Expert in JDE related to MMQC processes
• Inspection of all incoming material types
• Investigation and Deviation writing proficient
• Authoring/Updating documents related to MMQC
• Approval of GSA jobs
• Independent release of labels for use
• Approve label prints
• Approve external label request forms
• Verify variable data
• Perform effective rapid response
• Subject Matter Expert in JDE related to label release
• Investigation and Deviation writing proficient
• Authoring/Updating documents

One Approach
• Assist with DME training for new associates
• Reviewing/approving Deviations and Complaints
• Perform effective rapid response
• Attend/prepare for BRMs
• Client comment resolutions with assistance
• Drive effective rapid responses
• Complaint assessment
• Presentation of Quality items to clients and ELT
• Assist with other site/global quality items
• Authoring/Updating documents
• Train QS I and II associates
• Reviewing / approving engineering studies
• Review/ approval of Periodic reviews and requalification
• Reviewing /approving change controls and change actions
• Perform effective rapid response
• Presentation of Quality items to clients
• Assist with other site/global quality items]]> Thu, 26 Feb 2026 00:00:00 EST 1 Apple Project Commissioning Lead

Are you a seasoned professional with a passion for delivering seamless project commissioning in a cutting-edge technology environment? We’re seeking an experienced Apple Project Commissioning Lead to spearhead critical initiatives in a fully office and lab-based setting. This pivotal role offers the opportunity to work on innovative projects within a dynamic team, ensuring the successful commissioning of Apple-related systems and solutions. If you thrive in a fast-paced environment and possess the expertise to drive complex projects to completion, this is your chance to make a significant impact.

Required Skills:

• Proven experience in project commissioning, preferably within technology or related sectors
• Strong knowledge of Apple products and solutions (hardware, software, and integration)
• Excellent leadership and team coordination abilities
• Solid understanding of testing, validation, and troubleshooting procedures
• Exceptional communication skills, both verbal and written
• Ability to interpret technical documentation and develop commissioning plans
• Experience working in lab and office environments with a focus on technical accuracy

Nice to Have Skills:

• Previous experience working with Apple’s ecosystem and certification standards
• Project management certifications (e.g., PMP, Prince2)
• Knowledge of related industry standards and compliance requirements

Preferred Education and Experience:

• Bachelor’s degree in Engineering, Computer Science, or a related field
• Minimum of 5+ years of relevant commissioning or technical project experience
• Prior experience working on Apple-related hardware or software projects is highly desirable

Other Requirements:

• This position is fully office and lab-based
• The role is contract-based, with an initial 1-year term and provisioned end date in 2027
• Occasional travel may be required depending on project needs

Bring your expertise and leadership to a transformative project and help shape the future of Apple technology integration. If you’re ready to take on this exciting challenge, apply now and take the next step in your career!
]]> Thu, 26 Feb 2026 00:00:00 EST 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

  ]]> Thu, 26 Feb 2026 00:00:00 EST 0 Ready to take charge of a brand?new Orthopaedic portfolio in one of Australia’s most competitive territories? A rapidly scaling med?tech organisation is launching its Hip & Knee reconstruction line in Australia and needs a driven Territory Manager to own the Melbourne and VIC market from day one.

If you thrive in theatres, love building surgeon relationships, and want a role where your hustle shapes the territory, this is it.

---

What You’ll Own
Win the territory.
You’re the face of Hip & Knee reconstruction across Victoria. Build momentum fast — surgeon engagement, case support, OR presence, and relationship building are your daily rhythm.

Drive the numbers.
You’ll take the lead on revenue growth, account strategy, and expanding market share. This is a role for a closer who knows the value of proactive market coverage.

Strengthen partnerships.
Coordinate with distributor or agent partners where needed. Ensure stock, delivery and support run like a machine.

Read the market.
You’ll keep tabs on surgeon trends, hospital decisions, competitor moves, and long?term opportunities — and use it all to your advantage.

---

Who You Are

• 3+ years selling Hip & Knee implants
• Fully up?to?date experience in orthopaedic theatres
• Energised by winning new business and expanding accounts
• Confident operating solo and driving territory performance
• Skilled at building rapport quickly with surgeons and hospital decision?makers
• Experience with channel partners is a definite advantage

]]> 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
Type: Contract
Location: Remote UK

Are you passionate about shaping healthcare access and ensuring innovative medicines reach patients who need them most? We’re looking for a dynamic Senior HTA Manager to lead pivotal market access strategies in the UK and Ireland. This contract role offers a unique opportunity to influence reimbursement pathways, collaborate across global teams, and make a meaningful difference in patient lives.
In this role, you will be instrumental in leading complex HTA submissions, engaging with key agencies like NICE and SMC, and developing robust evidence-based dossiers. Your strategic partnership skills will be essential in aligning market access, medical, and commercial teams, while your health economics expertise will support impactful value propositions and negotiations.

Ideal candidates possess strong market access and health economic skills, excellent communication abilities, and the aptitude to manage multiple projects with precision. A postgraduate qualification in Health Economics or Outcomes Research and 5+ years of relevant experience, especially within oncology, are preferred.

Additional beneficial skills include network development, cross-functional collaboration, and experience managing health economics models and real-world evidence activities.

If you’re ready to make a tangible impact in healthcare, bring your expertise to this exciting opportunity. Apply now and join us in making medicines more accessible for patients across the UK and Ireland.]]> Thu, 26 Feb 2026 00:00:00 EST 1 Unlock Your Expertise as a Revenue Recognition Consultant – Join a Dynamic Team Driving Financial Excellence

Are you a seasoned finance professional with a passion for accuracy and compliance? Our client, a leading organization in the healthcare sector, is seeking a highly skilled Revenue Recognition Consultant to spearhead critical revenue assessments in line with international standards. This is a fantastic opportunity to bring your expertise to the forefront, supporting audits and streamlining revenue processes through innovative automation tools. If you thrive in a collaborative, fast-paced environment and possess a deep understanding of IFRS 15, this role is your chance to make an impactful difference while working on a flexible hybrid schedule in Heerlen, Netherlands.

What You'll Bring:

• Solid knowledge of IFRS 15 revenue recognition standards and principles
• Demonstrated experience executing revenue testing and supporting documentation
• Strong analytical skills with the ability to review complex transactions and contracts
• Excellent communication skills to liaise with cross-functional teams including Finance, Accounting, and IT
• Proficiency in leveraging automation and analytics tools to enhance testing efficiency
• Ability to coordinate testing activities and manage stakeholder expectations effectively

Nice-to-Have Skills:

• Prior experience working in or with Big 4 audit methodologies
• Familiarity with automating revenue recognition processes
• Knowledge of healthcare industry-specific revenue policies
• Experience with data integration from multiple sources to support testing

Preferred Education and Experience:

• Bachelor’s degree in Finance, Accounting, or related field
• Minimum of 3 years of experience in revenue recognition, audit, or financial compliance roles
• Prior hands-on experience supporting auditor testing or in a consulting capacity

Additional Requirements:

• Location: Heerlen, Netherlands (hybrid work model with 2-3 days on-site weekly)
• Contract Length: 6 months, with immediate start preferred
• Must have right to work in the Netherlands and be eligible to work independently

Take the next step in your professional journey by bringing your expertise to a pivotal role supporting global revenue standards. If you're ready to deliver impact with precision and innovation, apply now to become a key driver of financial integrity in this exciting consulting opportunity!
]]> Wed, 25 Feb 2026 00:00:00 EST 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, 25 Feb 2026 00:00:00 EST 1
Engineer - Complaints Technical Investigator:

Requires a combination of working remote and going onsite 2 to 3 times per week (average) for complaint returns assessment and/or laboratory equipment setup, development and validation of test methods.

Job Description
-Currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of the mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.

JOB RESPONSIBILITIES:

Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends

Provide input to engineering for product improvements

Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms

Lead root cause analysis to identify the failure mode for products and associated components due to product complaint

Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, 5 Whys, risk assessments such as FMEAs, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.

Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation

Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data

Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

PREFERRED QUALIFICATIONS

Masters Degree in Science
5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
Understand customer / patient use of packaged and/or distributed products
Understand manufacturing processes for packaged and/or distributed products
Proven experience with medical devices
Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
Experience with protocol and report writing, process and test development and execution, and design of experiments
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Strong technical writing and interpersonal skills

Committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.]]> Wed, 25 Feb 2026 00:00:00 EST 1 *Depending on experience

Job Description:

We are seeking a highly experienced Senior Employee Relations Specialist to manage moderately complex employee relations (ER) cases. This role involves conducting investigations, advising leadership, and ensuring compliance with employment laws and company policies. The ideal candidate will have a strong background in ER, labor relations, and conflict resolution, and will thrive in a fast-paced, collaborative environment.

Key Responsibilities:

Employee & Labor Relations
• Conduct confidential investigations into misconduct, including harassment, discrimination, and policy violations.
• Manage Compliance Hotline/Speak Up cases through resolution and document outcomes.
• Facilitate terminations, including drafting letters, conducting meetings, and maintaining documentation.
• Provide guidance to managers on employee relations best practices and fair treatment.
• Influence and coach leaders through sensitive employee situations.
• Partner with legal counsel and HR Business Partners to mitigate risk and ensure compliance.
• Interpret and apply company policies and collective bargaining agreements.
• Support unionized environments by resolving grievances and participating in arbitrations.
• Build positive relationships with employees, union representatives, and Works Councils.

Medical Accommodations
• Manage the medical accommodation process in collaboration with internal and external stakeholders.
• Facilitate interactive discussions with HR and medical experts.
• Advocate for employees while balancing business needs and values.
• Document accommodation decisions in the appropriate systems.

Corrective Action & Performance Management
• Educate leaders on corrective action processes and SMART objectives.
• Advise on performance issues and support development of performance improvement plans.
• Promote a culture of high performance and engagement.
• Maintain accurate records of employee actions and outcomes.

Training & Program Development
• Collaborate with the Learning department to develop and deliver ER-related training.
• Participate in the creation and implementation of ER programs and initiatives.

Special Projects & Administration
• Lead or contribute to special HR/ER projects, ensuring timely and effective delivery.
• Maintain accurate case management documentation for compliance and reporting.
• Perform additional duties as assigned.

Working Conditions:
• Ability to make decisions which have a significant impact on the department’s creditability, operations and services
• 10% overnight travel may be required
• Fast paced environment with frequent interruptions
• Some overtime hours may be required

Minimum Required Qualifications:
• Bachelor’s degree in human resources, Organizational Psychology, Business, or related field.
• 5-7 years of HR experience in employee relations, with a strong focus on investigations.
• Experience working in a fast paced; high-volume environment (required)
• In-depth knowledge of employment laws and HR compliance requirements.
• Experience using HRIS and case management systems.
• Strong written and verbal communication skills.
• High level of discretion and ability to handle confidential information.
• Ability to build relationships and influence stakeholders.
• Must be local to Holly Springs, NC and able to work onsite 4 days/week.

Preferred / Nice to Have Qualifications:
• Experience in unionized environments and labor relations.
• SHRM certification (SHRM-CP or SHRM-SCP).
• Bilingual in English and Spanish - strong preference.
• Experience supporting multiple locations and working in a global, matrixed organization.]]> Wed, 25 Feb 2026 00:00:00 EST 1
Basic Qualifications
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

This position will, under supervision, execute deliverables for a project to implement new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position.

This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site(s).

This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which includes, but is not limited to, expectations of training and documentation practices.

This position will work in a team environment, collaborating with various colleagues in the network to ensure project commitments are met. They will report status/updates of key responsibilities and escalate any issues through the project management team.]]> Wed, 25 Feb 2026 00:00:00 EST 1
Role Description:

The Supplier Quality Engineer II will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Operations, Quality, Sourcing, and RA.

Job Function:

• Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Works with suppliers to ensure quality system and supplied product requirements are understood and successfully met.
• Responsible for helping define supplier qualification requirements for OEM and custom materials and devices.
• Ensures validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and Industry best practices.
• Supports completion of Design Development File requirements applicable to supplied components, subassemblies, devices, and services.
• Supports risk management and validation activities with suppliers.
• Develops inspection methods and procedures for receiving inspection and/or supplier final release.
• Executes test method validation activities for receiving inspection and/or supplier final release.
• Knowledge of NCR & CAPA elements is preferred.
• Assesses non-conformances and leads closure of SCARs as needed.

Required Education / Qualifications:

• Bachelors degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions
• Highly regulated industry experience

Preferred Qualifications:

• Engineering degree
• Experience with supplier quality engineering activities, including external supplier vendor audits
• Effective problem-solving techniques and experience with technical tools (i.e. Root Cause Analysis, dFMEA process, Gage R&R, etc.)
• Proficient understanding of Design Controls, test method development & validation, and risk management.
• Conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs
• Experience with class II and class III medical devices
• Medical device, pharma, biotech or other regulated industry experience
• Demonstrated ability to apply statistical quality engineering tools
• Ability to read and interpret drawings
• Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred.
• Ability to manage multiple and frequently changing projects and priorities.
• Ability to work independently without close supervision
• Effective communication and conflict resolution skills
• Highly developed time management, communication, and documentation skills
• Strong communication and organizational skills to effectively manage and get results with external suppliers
• Six Sigma Black Belt/LEAN Manufacturing experience
• ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor
• Domestic and international travel up to 25% (post-COVID)]]> Wed, 25 Feb 2026 00:00:00 EST 1 Duties:

• Package vaccines, run machinery
• Label and package finished good
• 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.

Skills:

• 2 to 3 years manufacturing experience.
• Detail oriented with effective communication skills and quality conscious.
• Equipment/Process troubleshooting skills.
• Ability to lift up to 35 lbs.
• Basic math and computer skills.

Preferred:

• 5+ year of related experience.
• Forklift certified.

Education:

• HS diploma.
• Associates preferred or equivalent experience.

Pay Rate: $20/hr
]]> Wed, 25 Feb 2026 00:00:00 EST 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

]]> Wed, 25 Feb 2026 00:00:00 EST 0 Title: EHS Specialist
Type: Contract
Length - 6 months
Location: South East UK (100% onsite)
Full-Time

Discover an exciting opportunity to make a meaningful impact as an EHS Specialist. In this vital role, you will provide hands-on support to ensure the safety, health, and environmental compliance of a dynamic manufacturing facility. Working closely with the EHS team, you'll develop risk assessments, deliver targeted training, and assist in incident investigations, helping to create a safe and compliant work environment.
The ideal candidate will possess 3-5 years of experience in a GMP manufacturing setting, preferably within biotech, pharmaceutical, or similar technical environments. A strong understanding of UK HSE legislation, excellent communication skills, and a NEBOSH certification (General Certificate at minimum) are essential. Experience developing risk assessments, SOPs, and COSHH assessments will be highly valued.
While not mandatory, candidates with a NEBOSH Diploma or experience in vaccine or drug development industries will stand out. The role requires full-time onsite presence at the client  site, starting as soon as possible for an initial three-month period, with potential for extension.
If you're a proactive EHS professional passionate about workplace safety and compliance, this is your chance to contribute to a cutting-edge facility. Apply now to join a forward-thinking team committed to safety excellence and innovation.
 
]]> Wed, 25 Feb 2026 00:00:00 EST 1 *Depending on experience

Summary:
The main function of a quality engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes and develop quality standards. A typical quality engineer has the ability to read and interpret blueprints, and evaluate product integrity and standards.

Job Responsibilities:
• Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
• Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
• Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately.
• Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971
• Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
• Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities.
• Strong leadership and collaboration with other leaders in project and across the organization
• Mentor engineers in understanding of quality systems and strategies within new product development.
• Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
• Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools.
• Support Quality Engineering activities to improve customer satisfaction and successful achievement of company quality objectives.
• Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
• Train, coach, and guide lower-level employees on more complex procedures
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.

Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Basic leadership and mentoring skills necessary to provide support and constructive performance feedback.
• 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).

Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 years experience required.]]> Wed, 25 Feb 2026 00:00:00 EST 1 QC Scientist – Biologics

Join a dynamic, fast-paced GMP/GLP-regulated environment in Barcelona as a QC Scientist specializing in Biologics. This is your chance to be part of a growing team supporting cutting-edge biologics testing, with a strong focus on HPLC and chromatography techniques. Ideal for industry-trained analysts seeking to elevate their careers into a Scientist role, this opportunity offers valuable hands-on experience in high-quality biologics QC operations, working closely with experienced professionals and contributing to impactful projects.

Required Skills:

• 1–2 years of industry experience in pharma, biotech, or CRO sectors
• Strong hands-on expertise with HPLC
• Knowledge of GMP or GLP environments
• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, or related field
• Excellent command of English; Spanish proficiency is highly desirable
• Proactive mindset, ability to work effectively under pressure
• Experience preparing QC documentation (SOPs, CoAs, deviations, OOS, CAPAs)

Nice to Have Skills:

• Additional chromatography techniques
• Experience supporting QC studies or method validation
• Familiarity with client-facing roles in international settings

Preferred Education and Experience:

• Industry experience preferred over academic research
• Proven ability to operate in GMP/GLP labs with a focus on biologics

Other Requirements:

• Willingness to work rotating shifts (morning and afternoon)
• Relocation support not provided
• Ability to communicate fluently in English and Spanish

Ready to take the next step in your career? Apply now and become a vital part of a forward-thinking team committed to scientific excellence in Barcelona!
]]> Wed, 25 Feb 2026 00:00:00 EST 1 The basic purpose of this role is to perform any process/support duties associated with the automated filling of vaccines. The Technician I, Filling Athens works within the filling department as a team member to ensure success in the activities associated with the safe and sterile preparation of vaccines

Duties & Responsibilities

·         Performs filling and support production activities.
·         Operates relevant department equipment in appropriate manner and in accordance with requirements.
·         Ensures all equipment and facilities are maintained.
·         Maintains a clean and safe work environment.
·         Completes all associated documentation in compliance with requirements.
·         Demonstrates sound aseptic technique.
·         Performs inventory transactions.
·         Monitors Key Performance Indicators to strive for improved performance.
·         Communicates process needs and progress to colleagues and supervisor. 
·         Escalates events and concerns to supervisor.
·         Demonstrates a visible & tangible commitment to HSE, Lean Principles, and the company Values in all work-related activities.
·         In addition to the above, other assigned duties & projects deemed appropriate within the position scope.

Skills:    
one(1) year relevant experience OR B.S. degree

Education:    
High school diploma or equivalent plus 





Pay Rate: $20/hr]]> Wed, 25 Feb 2026 00:00:00 EST 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

]]> Wed, 25 Feb 2026 00:00:00 EST 1
Laboratory Operations & Equipment Expertise:
Support the setup and launch of the new Process Technologies & Development lab space, including organizing the workspace, assisting with equipment installation and qualification, and ensuring all systems are ready for routine study execution.

Operate, maintain, and troubleshoot a wide range of primary container and analytical laboratory equipment (e.g., leak detection systems, headspace analyzers, optical and particle counting microscopes, microCT scanners, automatic filling equipment, filtration and mixing tanks, balances, etc.)
Independently refine and develop existing laboratory processes and equipment workflows to improve efficiency, robustness, and usability, ensuring that methods and operational practices are easily adoptable by other teams.
Maintain accurate equipment logs, calibration verifications, and support routine instrument readiness for ongoing studies. Ensure the laboratory environment is well-organized, including consumable tracking, chemical inventory, and compliance with the companies safety, quality, and documentation requirements.
Partner with Facilities, Metrology, EH\&S, and cross functional PD teams for seamless lab operations and timely issue resolution.

Scientific Excellence & Continuous Improvement:
Apply sound scientific judgment in planning and troubleshooting studies.
Support method development, lab workflow optimization, and evaluation of new technologies relevant to primary container development and characterization.
Drive improvements in lab workflows, equipment utilization, and operational efficiency.
Proactively maintain a culture of cleanliness, organization, and scientific excellence in the lab.

Minimum Qualifications:
Bachelors or Masters degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
Hands-on laboratory experience (academic or industry) with strong familiarity in equipment operation and lab best practices.
Demonstrated experience designing and executing experiments with attention to detail and scientific rigor.
Strong organizational skills with a track record of maintaining a clean, structured, and efficient laboratory environment.
Excellent communication skills and ability to manage multiple priorities in a fast paced setting.

Preferred Qualifications:
Experience supporting laboratory setup, including equipment installation, qualification, and initial operational readiness.
Strong organizational skills with the ability to maintain a clean, structured, and well-run lab environment.
Familiarity with a broad range of laboratory equipment, with hands-on capability in routine operation, troubleshooting, and maintenance.
Familiarity with studies involving container closure integrity (CCI), extractables/leachables, device drug interface, or fill finish operations.
Ability to design and refine lab workflows that improve efficiency, robustness, and usability across teams.
Previous experience working within cross-functional development teams.

Pay ranges between 48-55/hr based on experience ]]> Wed, 25 Feb 2026 00:00:00 EST 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, 24 Feb 2026 00:00:00 EST 1

Wir unterstützen ein international tätiges Medizintechnik- und Diagnostikunternehmen bei der Suche nach einem Account Manager (m/w/d) für den Ausbau des Geschäfts im Großraum Köln. In dieser Rolle übernehmen Sie die volle Verantwortung für den Vertrieb moderner Diagnostiklösungen und treiben das Wachstum in Kliniken und Laboren aktiv voran.

---

Ihre Aufgaben

• Eigenverantwortliche Betreuung und Entwicklung von Kliniken und Laboren auf allen Hierarchieebenen.
• Gewinnung neuer Kunden sowie Ausbau bestehender Partnerschaften im definierten Vertriebsgebiet.
• Steuerung des gesamten Verkaufsprozesses – von der Bedarfsermittlung über Präsentationen bis zum erfolgreichen Abschluss.
• Strategische Gebiets- und Potenzialanalysen zur Identifikation neuer Geschäftschancen.
• Umsetzung kundenspezifischer Projekte im Einklang mit Vertriebs- und Marketingstrategien.
• Analyse komplexer Verkaufschancen und Entwicklung eigener Verkaufsstrategien.
• Nutzenorientierte Positionierung des Produktportfolios entlang der Customer Value Chain.
• Nutzung des CRM-Systems (Salesforce) für Dokumentation, Pipeline-Steuerung und Opportunity Management.
• Beobachtung von Markt- und Wettbewerbsentwicklungen.
• Teilnahme an Veranstaltungen, Workshops und Messen sowie gelegentliche Unterstützung im Reklamationsmanagement.
• Enge Zusammenarbeit mit Marketing, Produktmanagement, Technik und Customer Service.

---

Ihr Profil

• Mindestens 2 Jahre Vertriebserfahrung in Diagnostik, Medizintechnik oder Laborsystemen.
• Erfahrung in Molekularbiologie und/oder Mikrobiologie – durch Studium oder Vertrieb.
• Nachweisbare Erfolge im Verkauf an Krankenhäuser und/oder Labore.
• fließende Deutsch- sowie sehr gute Englischkenntnisse.
• Abgeschlossenes Studium in Biologie, Biotechnologie, Medizintechnik oder vergleichbarer naturwissenschaftlicher Fachrichtung.
• Gutes betriebswirtschaftliches Verständnis sowie ausgeprägte analytische und konzeptionelle Fähigkeiten.
• Sicherer Umgang mit CRM-Systemen und modernen IT?Tools.
• Hohe Reisebereitschaft innerhalb des Vertriebsgebiets (ca. 80%).
• Professionelle Kommunikation, Überzeugungskraft, Kreativität und ein souveränes Auftreten.
• Eigenmotivation, Belastbarkeit, Lernbereitschaft und ein hoher Grad an emotionaler Intelligenz.

---

Warum diese Rolle interessant ist

• Tätigkeit in einem innovationsgetriebenen Umfeld mit spürbarem Impact auf die Gesundheitsversorgung.
• Hohe Eigenverantwortung und großes Gestaltungspotenzial im Vertriebsgebiet.
• Zusammenarbeit mit einem engagierten, interdisziplinären Team.
• Moderne Arbeitskultur mit Fokus auf Weiterentwicklung, Flexibilität und persönliches Wachstum.

---

Wenn Sie Diagnostik lieben, Vertrieb leben und im Klinik- und Laborumfeld zu Hause sind, bietet diese Position die Chance, ein Gebiet nachhaltig zu prägen und echten Mehrwert zu schaffen.
]]> Tue, 24 Feb 2026 00:00:00 EST 1
Research Associate I responsible for designing and performing experiments while collaborating and communicating effectively.


Primary Responsibilities for the Role: ? Performs minimally complex experiments with input from supervisor.
? Understands experimental goal and may provide input to the experimental design.
? Analyzes data from individual experiment with input from supervisor and documents work in laboratory notebook or report.
? Able to summarize a group of experiments.
? Effectively communicates with peers and supervisor. May present data in group meetings.
? Prepares reagents and panels.
Additional Responsibilities: ? Participates in lab maintenance activities.
? Maintains training log.
? Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.
? Operates and calibrates all general lab equipment.
? With instruction from supervisor, may write study protocols and reports to support part of the project.
Knowledge, Skills and Abilities: ? Good knowledge of GLP.
? Working knowledge of laboratory safety and record keeping.
? Strong mathematics skills.
? Strong written and verbal communication skills.
? Microsoft Office Suite: Powerpoint, Excel, Word.
Education: • B.A./B.S. Molecular Biology, Chemistry, Biochemistry or related field Experience: • 0 - 2 years post-baccalaureate laboratory experience in academia or industry
• M.S. without thesis
Equivalency: Depending of the area of assignment, directly related experience or a combination of directly related education and experience and/or competences may be considered in place of the state requirements. Example: if a job Level typically requires an Associates’ Degree plus 2 years of experience, an equivalent could be included 4 years of experience or a Bachelor’s Degree. Occupational Demands Work is performed in both a lab and an office environment. Frequently sits for 4-6 hours per day. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Some occasional travel within the United States. Able to communicate complex information and ideas so others will understand; ability to listen and understand instruction. Ability to apply abstract principles to solve complex conceptual issues.


 

Pay Rate: $24/hr ]]> Tue, 24 Feb 2026 00:00:00 EST 1

 Executes routine unit operations in Visual Inspection 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.

Executes independently with adequate training, complex fundamental operations as visual inspection, advance visual inspection, palletizing, cleaning, inspection hood prep for operations, BioMES Operations and Exceptions. 

Performs internal support duties including assisting drug product filling and packaging.

Executes independently with adequate training fundamental operations: -Logistics Coordination
-Batch record executions
-Equipment use logs
-Work order initiation and tracking
-Support Projects
-Support Creation/Maintain Training Kits Documents work according to cGMP and cGDP.
-Adheres to established regulations and follows cGMP established by site.
-Reports abnormalities and deviations in a timely and accurate manner.
-Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
-Maintains production areas according to predefined standards (5s).
-Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
-Contributes to Quality activities such as supporting investigations, corrective actions and area walk throughs.
Skills:    

• 1 or more years of experience in cGMP regulated industry.
• Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and “Right the first-time” mindset.
• Strong written and verbal communication skills.
• Ability to work with computer-based systems and manufacturing execution systems (MES).
• Ability to read and understand SOPs and instructions and document work in a written format applying cGMP standards.
• Ability to work as part of a high performing team and collaborate effectively with staff.
• Must be able to read and see clearly.

Education:    

• High school degree + minimum 1 year work experience in GMP regulated industry 
• Associates/Bachelor’s degree or biotechnology vocational training preferred

PHYSICAL DEMANDS:

• Duties of this position may require the incumbent to exert some physical effort.
• Lifting requirements may vary dependent on the drug product manufacturing visual inspection area activity. Weight is typically no more than 25 pounds. 
• Employees required to participate and have acceptable result from vision testing including color blindness. 

Pay Rate Range: $20-28/hr depending on experience ]]> Tue, 24 Feb 2026 00:00:00 EST 1 Head of R&D Brachy Solutions

Seeking an inspiring and strategic leader to helm our R&D Brachy Solutions division, driving innovation and excellence in a highly regulated industry. This pivotal role offers the opportunity to lead a dynamic, multidisciplinary team of 60-70 experts in developing cutting-edge software and hardware products that directly impact patient care. As the cornerstone of our innovation pipeline, you will shape the technology roadmap, ensure disciplined project execution, and foster a culture of continuous improvement—all while collaborating with cross-functional partners and maintaining full regulatory compliance. This is your chance to make a meaningful difference in medical technology while advancing your leadership career in a forward-thinking organization.

Required Skills:

• Proven senior leadership experience managing large R&D teams (20+ staff), with a background in software development, AI, and regulated industries such as medical devices.
• Strong track record in product lifecycle management, including delivery of new product development (NPD), upgrades, and sustaining activities within scope, timeline, and budget.
• Extensive experience in project portfolio management, resource planning, and cross-functional collaboration.
• Exceptional communication skills in English, with the ability to effectively engage with internal teams, external research partners, and supply chain stakeholders.
• Demonstrated ability to set and execute strategic roadmaps, including product management and innovation drivers.
• Sound understanding of regulatory standards such as MDR/CE and FDA/510(k), and familiarity with design controls, verification & validation processes.
• Strong leadership qualities, including the ability to say no, manage multiple priorities, and motivate a high-performance culture.

Nice to Have Skills:

• Experience in software development involving AI applications, especially in medical or healthcare technology.
• Background in securing R&D subsidies, scientific research collaborations, and managing IP/IP strategy.
• Knowledge of hardware components related to medical devices and their integration with software solutions.
• Fluency in Dutch or experience working in the Netherlands would be advantageous but is not mandatory.

Preferred Education and Experience:

• Master’s degree in Engineering or a related scientific field; PhD preferred.
• At least 10+ years of progressive leadership experience in R&D, preferably within regulated industries such as medical technology.
• Demonstrated success leading multidisciplinary teams in fast-paced, innovative environments.

Other Requirements:

• Must be willing to work on-site in Utrecht, Netherlands, five days a week; occasional remote work is acceptable but not regular.
• Open to relocation support for qualified candidates.
• Ability to build strong relationships with clinical, regulatory, and commercial teams.
• A proactive, results-driven mindset aligned with ethical values, focusing on impactful patient outcomes and efficient resource utilization.

If you are ready to lead groundbreaking R&D initiatives in a company dedicated to transforming patient care through innovation, we encourage you to apply and become a key driver of our next chapter.

]]> Tue, 24 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 Position Title: Clinical Research Territory Manager
Reports To: Senior Global Manager.
Department: Market Development & Recruitment
Location: Australia (field-based role)

Role Overview:
This is a field-based business development position focused on driving clinical study recruitment through proactive engagement with healthcare professionals, including ophthalmologists, optometrists, and clinical practices. The successful candidate will be responsible for building and maintaining strong relationships across the ophthalmic community to generate patient referrals and increase study awareness.

Key Responsibilities:

• Develop and maintain target lists of potential healthcare professionals to drive patient recruitment into clinical research studies.
• Execute outreach strategies to direct qualified patients to designated clinical research sites, meeting enrolment targets.
• Cultivate relationships through regular in-person visits, calls, and digital communication.
• Organize and coordinate professional education events such as dinners, lunch-and-learns, and workshops.
• Support training and education initiatives for clinical site staff as required.
• Provide on-site support and proctoring during treatment sessions when needed.
• Assist in managing study tracking systems and report progress or trends to the clinical team.
• Ensure adherence to Good Clinical Practice (GCP) and company Standard Operating Procedures (SOPs).
• Complete reports and documentation accurately and in a timely manner.
• Perform other duties as assigned to support the overall success of the clinical study recruitment function.

Qualifications:

• Minimum of 3 years’ experience in medical sales, ideally within optometry, ophthalmology, or medical devices.
• Bachelor’s degree in a relevant field preferred.
• Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and the Declaration of Helsinki is advantageous.
• Strong communication, interpersonal, and organizational skills.
• Demonstrated ability to work both independently and collaboratively within a team.
• Proven self-starter, capable of managing multiple priorities in a dynamic, fast-paced environment.

Performance Measures:

• Achievement of patient enrolment targets at supported clinical sites.
• Accuracy and timeliness in execution of outreach and reporting activities.
• Quality and consistency in professional engagement with clinical stakeholders.

Additional Information:

• National travel required for site visits, training, and professional events.
• Ideal candidates will be confident engaging with healthcare professionals and discussing topics such as patient identification, visual acuity testing, and clinical study processes.
• Suitable backgrounds may include medical representatives, ophthalmic device sales professionals, or candidates experienced in eye care and diagnostic imaging.

]]> Tue, 24 Feb 2026 00:00:00 EST 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 ]]> Tue, 24 Feb 2026 00:00:00 EST 1
Are you a seasoned pharmacologist passionate about shaping innovative therapies? We are seeking a dynamic Senior Clinical Pharmacology Manager to lead the development and execution of clinical pharmacology strategies for ground breaking small-molecule programs. In this pivotal role, you will directly influence key decision-making processes, support regulatory interactions, and help build a cutting-edge clinical pharmacology function within a forward-thinking biotech environment.

Required Skills:

• PhD, PharmD, MD, or equivalent in pharmacology, pharmaceutical sciences, or related field
• Over 10 years of experience in Clinical Pharmacology within biotech or pharma
• Expertise in PK/PD, population modelling, PBPK, dose optimization, and quantitative pharmacology
• Proven ability to design, analyze, and interpret clinical pharmacology studies
• Strong project management and organizational skills
• Excellent communication skills in English; additional languages advantageous

Nice to Have Skills:

• Experience supporting organ-restricted or targeted pharmacology strategies
• Prior leadership or mentoring experience
• Familiarity with regulatory submissions and interactions

Preferred Education and Experience:

• Advanced degree with extensive experience in small-molecule drug development
• Demonstrated track record in clinical pharmacology within a fast-paced environment

Other Requirements:

• Willingness to travel as needed
• Ability to operate effectively in a collaborative, multi-disciplinary team

Take the next step in your career by contributing to transformative therapies in a fast-paced, innovative setting. If you're ready to make an impact, we encourage you to apply now and join us in advancing ground breaking medical solutions.

Hybrid worker from France, Belgium or Netherlands


 ]]> Tue, 24 Feb 2026 00:00:00 EST 1 *depending on exp

Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues. Additional responsibilities will include support in development of audit readiness materials and gmp documentation generation and review. This is an on site position.

Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience

Day to day responsibilities: 
General validation and commissioning support, generation and management of documents, support of audit readiness, other engineering support tasks.
 ]]> Tue, 24 Feb 2026 00:00:00 EST 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]]> Tue, 24 Feb 2026 00:00:00 EST 1 With direct supervision, this individual will perform routine clinical manufacturing operations at the Norton Manufacturing Facility, ensuring safe, efficient, and cGMP-compliant operations at all times. Responsibilities include, but are not limited to, operation of production equipment in the areas of weigh/dispense, solution preparation, equipment CIP/COP and small parts cleaning, and materials stocking in manufacturing suites. Operates production equipment according to SOPs for the production of clinical products. Requires interaction with support groups (Facilities, QC, QA, Materials Management, EHS) to ensure accurate completion of activities.

Required Qualifications:
Bachelor's Degree

Pay ranges between $28-33hr based on experience ]]> Tue, 24 Feb 2026 00:00:00 EST 1 SUMMARY/JOB PURPOSE:

Seeking a Temporary Legal Project Manager facilitate high priority projects for the Legal Department and its affiliated groups, reporting to the Senior Director, Legal Operations. This role will have primary responsibility for project management of several legal initiatives.   

CORE ASSIGNMENTS:

• LEAP Program 1H2026: Plan and implement the Legal Department’s continuing education (LEAP) program through June of 2026.  This includes soliciting themes and topics from Legal Leadership, working with outside counsel to provide high quality in-person educational programs on legal topics of interest, and managing the execution of the events. (Execution of the events includes scheduling the presentation with the law firm and participants, reserving conference rooms, serving as Host for the Zoom meeting for remote participants, tracking attendance, ensuring the presenters share Continuing Legal Education reference information for those who need credits, and obtaining any feedback Legal Leadership requests.) 
• Quarterly Legal+ Meetings: Plan and manage the Legal / Compliance / QA Department’s Quarterly Meeting internal presentation programming, which includes specific substantive content which will be included in the meeting organized by the Legal Department Executive Assistant.  The work includes obtaining proposals from Legal Leadership and from others for Legal Leadership’s consideration, collaborating with internal experts who will speak or present on such themes, reserving their time slot in the quarterly meeting schedule, and ensuring quality and consistency of the presentation content through careful review, including screening by the LLT.
• Legal Templates Project Phase 2: Project manage the delivery of a fixed number of legal document templates for cross-functional use across the Legal Department.  A task force will be assigned to agree on language that can be built in the Contract Lifecycle Management System; your role will be to schedule the review, negotiation, and finalization of the language, participate in progress meetings with the participants, schedule the configuration and testing of the templates with the CLM Administrator, and organize the change management plan for the template launches.
• Screens AI Pilot: Project Manage the pilot testing effort of a new software tool that utilizes software to compare incoming contract proposals against internal company standards. 
• Other: project manage other assigned ad hoc projects within the Legal Department,  approved by your supervisor, using LPM methodology.

KEY PROJECT MANAGEMENT ACTIVITIES & EXPECTATIONS

• Scheduling: overall project scheduling, team meeting scheduling, task assignments with deadlines, progress reports.  Overall project management should occur in Microsoft Planner, so that actions can be centrally assigned and progress can be shared through the project plan.
• Minutes/Notes: keep notes of project meetings, including attendees, subjects discussed, decisions reached, and action items assigned (with due dates); share them within Microsoft Teams Channel dedicated to each project.
• Action Item Follow Up/ Task Close Out: intervening with reminders to ensure tasks are completed.
• Escalation: communicate 'stuck' activities to manager and Legal Leadership if risks to schedule appear.
• Status Reports: providing weekly progress reports on activities completed and whether each project remains on schedule.  Includes overall status reports (roll-ups) for your manager and Legal Leadership, and individual status reports for the project teams.
• Project Communications: generally:
  • Microsoft Teams: the content for these projects will be managed in Microsoft Teams channels; light communication can be hosted in the channel chats and/or via email
  • Microsoft Planner: the schedules will be managed through Planner, which can be posted to Teams
  • Outlook:  meetings will be scheduled through Microsoft Outlook, special ticketing requirements through JSM may be required to schedule certain larger training rooms
  • Outlook: Status Reports and other content for Legal Leadership will be distributed by email copy, with links to the main content for reference.

Minimum Requirements:

Education:  No specific degree requirement

Number of years of experience: 5+ years required

Software knowledge/requirements: Microsoft Office, plus Microsoft Planner or similar project management/scheduling software required

Industry background: Previous experience in Law Firms or Legal Departments preferred; Life Sciences experience desirable

Certifications: Project Management Professional (PMP) or Certified Associate in Project Management (CAPM)


 
]]> Tue, 24 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!
]]> Tue, 24 Feb 2026 00:00:00 EST 1 Join Our Team as an Omnichannel Strategy Manager  

Are you a strategic visionary with a passion for shaping next-generation customer engagement across digital and offline channels? We are seeking an experienced Omnichannel Strategy Manager fluent in Spanish or Italian to lead transformative brand campaigns from our Uxbridge office. This pivotal role offers the chance to influence global pharmaceutical brand strategies, working within a dynamic, matrixed environment and supporting exciting product launches across diverse markets.

What You’ll Do:

• Develop and execute sophisticated omnichannel strategies that drive customer engagement and deliver measurable business impact.
• Translate brand visions into impactful customer-centric communication plans, leveraging insights and data analytics.
• Lead cross-functional teams, including marketing, medical, and digital partners, ensuring seamless campaign execution aligned with strategic objectives.
• Utilize advanced analytics to develop KPIs, measure campaign effectiveness, and optimize ongoing strategies.
• Collaborate with external agencies and internal stakeholders to innovate and implement digital tactics that resonate across multiple customer segments.
• Influence and coach teams on adopting agile content production and deployment practices, fostering a culture of continuous improvement.
• Maintain a keen awareness of industry trends and competitive landscape to embed best practices into strategic planning.

Essential Skills & Qualifications:

• Fluent in Spanish or Italian, with excellent reading, writing, and spoken communication skills.
• 6+ years of senior-level experience in omnichannel marketing, preferably within the pharmaceutical sector, with a strong track record of strategic leadership.
• Proven expertise in translating brand strategies into customer engagement campaigns that impact revenue and growth.
• Strong analytical capabilities, with a capacity to derive actionable insights from data and metrics.
• Exceptional stakeholder management skills, able to influence across diverse teams without formal authority.
• Experience managing large-scale, complex projects within a matrix organization.
• Demonstrated ability to lead change, foster collaboration, and deliver innovative digital solutions.

Nice to Have:

• Knowledge of EU healthcare regulations and compliance standards.
• Familiarity with digital content management systems and marketing automation tools.
• Previous experience supporting product launches or indication-specific campaigns.
• Multilingual abilities beyond Spanish or Italian.

Preferred Education & Experience:

• Bachelor’s degree required; MBA or advanced degree preferred.
• 8+ years in digital marketing, omnichannel strategy, or related leadership roles within the healthcare or pharmaceutical industries.
• Experience working with external agencies and cross-border teams.

Other Requirements:

• Willingness to travel regularly within markets, approximately every 6-8 weeks.
• Ability to work within a hybrid model, with core days on-site (Tuesdays & Wednesdays) in Uxbridge.
• A proactive, energetic mindset and passion for innovation in customer engagement.
• Commitment to upholding confidentiality and ethical standards in a regulated industry.

Ready to bring your strategic expertise to a global leader and make a tangible impact in healthcare marketing? Apply now to join a forward-thinking team committed to excellence and innovation.
]]> Tue, 24 Feb 2026 00:00:00 EST 1 Target PR Range: 80-90/hr
*Depending on experience
 

Enable Commercialization of NPI’s, Portfolio Management of On Market Support projects and provides Project Management expertise across the CAD Organization. Develop, implement and lead NPI program from R&D handover to final launch and commercialization. Lead strategic product support programs in order to ensure robustness of supply, quality products, and appropriate levels of customer service, while minimizing costs and maximizing benefits. Keep upper management informed as to the status of projects, integrate change as applicable and recommend value-added alternatives. Drive integration of cross-functional organizations to deliver an integrated technical solution.
• To manage the execution of project(s) across the PDS&T organization, Franchise Organizations, and Third-Party Suppliers.
• Coordinate global project teams to perform NPI program management, technical transfers of products, product maintenance and global launches of new combination device and device programs.
• To carry out and implement process improvement initiatives.
• Manage execution of tasks and co-ordination of projects in both remote and office-based settings.
• Open to lead activities across different time zones and be flexible to be available, as appropriate to align with other time zones.

• Develop realistic cross functional project implementation plans with input from other functions, e.g., R&D, Engineering, Manufacturing, Quality, Regulatory, and Commercial.
• Utilize the relevant PM tools for project planning, monitoring, and reporting.
• Maintain project budgets and timelines.
• Set project milestones and report progress accordingly. Consider alternative approaches and take corrective action as needed to ensure project milestones are achieved.
• Provide project management support for and guide the efforts of third-party organizations (vendors, suppliers, contractors, etc.) to enable achievement of shared milestones.
• Fulfil management role in terms of organizing project teams, facilitating communication between resources, guiding technical, financial, business and personnel conflict resolution and monitoring budget administration.
• Identify and implement opportunities that will improve ability to implement and deliver quality products in a cost effective, compliant, and timely manner.
• Support the development of the Program Management process for the PDS&T organisation.

The Employee will perform duties appropriate to this position as instructed by the Company. He / she will be required to be flexible and to undertake any such additional or alternative duties as the Company shall reasonably assign to the Employee from time to time. The Company also has the right to ask the employee to move to another work location without seeing consent at the time of the transfer.

EHS Responsibilities:
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in eAchieve;
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on eAchieve;
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.
Education/
Other • Degree in Engineering / Science or related discipline.
• Advanced business degree is benefit.
• PMI certification is highly desirable.
• Green Belt or Black Belt in Lean Six Sigma is desirable
Job Skills/ Experience Required Technical/Business Knowledge -Job Skills
• 10+ years of diversified business experience, including operations support/quality at plant level for medical products and/or medical devices, supply chain, validations, capital and expense management, and commercial product launches.
• Knowledge of good R&D practices and design control.
• Knowledge of medical device, pharmaceutical industry (or Combination products) is required.
• 5+ years of medical device and pharma experience is required.
• High level of competence with all Microsoft packages including Microsoft Project.

The successful candidate should possess the following characteristics:
• Broad, diverse, cross-functional, and cross-divisional experience.
• Able to think strategically and creatively.
• Able to establish and maintain credibility as a leader.
• Ability to comprehend complicated global product movement plans and logistics.
• Ability to drive change throughout the company; results oriented.
• Familiar with overseas operations and cultures.
• Delivers results with a minimum amount of direction and supervision.
• Communicates results, actions, decisions, concerns in a timely manner.
• Decisive; moves quickly to core issues while avoiding tangents and/or excessive detail.
• Acts with sense of urgency.
• Inspires others to work hard.
• Team player and team builder.
• Effectively builds consensus.
• Ability to deal effectively with all levels of personnel.
• Manages change positively.

Cognitive Skills
• Required to undertake specific investigations, and business process monitoring with the view to improve efficiency and performance e.g. reducing complexity and maximizing output and benefit.
• It may be necessary to re-design elements or entire business processes to adapt to changing business conditions in order to improve efficiency and remove waste.

Influence/Leadership
• Considerable and continual care and attention needed to avoid non value added activities within a program or associated business process.
• Continual attention needed to ensure Leadership are appropriately informed of program or project progress using the recognized escalation processes and governance models.
• Be a leader of the team and ensure the team have what they need to be successful.

Accountability / Scope:
• Establish timetables, set goals/priorities, develop performance measurements, and assign/prioritize resources.
• Measure progress and results accurately and completely.
• Generate ideas for improvement which are consistent with the organization’s mission and strategy.
• Achieve timelines and capital/expense commitments.

?*CO/NYC candidates might not be considered
]]> Tue, 24 Feb 2026 00:00:00 EST 1 *depending on exp

JOB DESCRIPTION
Job Title: Automation Application Specialist

Job Purpose:
We are seeking a highly motivated candidate for the role of Automation Specialist. In this role, the successful candidate will work on-site at clients' locations to provide support, responsiveness, and knowledge tailored to the customized specifications of the clients' users. The Automation Specialist will conduct crucial experiments to advance laboratory operations, utilizing the clients' existing lab processes and facilities to ensure the seamless delivery of high-quality results within established timelines. The ability to operate automated systems and associated instrumentation, and execute cell-based and biochemical assays (luminescence, fluorescence, AlphaScreen, imaging, etc.) is required.

Key Responsibilities:

• Leverage integrated assay automation platform to execute medium-high-throughput cell-based screens and assays in collaboration with therapeutic area and functional area scientists.
• Train equipment users on key concepts associated with the platforms to support best practices and mitigate avoidable run failures, ensuring optimal routine operation.
• Assist with programming the automated platform for assay protocol development.
• Act as the 'first-responder' for troubleshooting and error recovery.
• Maintain cell lines and primary cell cultures.
• Demonstrate flexibility in accommodating rapidly changing priorities and deadlines.
• Manage laboratory inventories.
• Ensure compliance with laboratory safety procedures and guidelines.
• Support equipment maintenance and establish strong relationships with OEM Service Organizations.
• Interact with other engineers to leverage platform/systems knowledge to minimize instrument downtime.
• Maintain training and compliance in areas of health and safety, security, environmental, and operational aspects of daily activities in the working environment. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.
Competencies:

• Bachelor’s degree in Engineering, Life Sciences, or related discipline with 2 years of experience in laboratory automation and/or lab instrumentation support OR Associate degree with 5+ years of experience in laboratory automation and/or lab instrumentation support.

• Experience with equipment such as Tecan Fluent, Combi, BlueWasher, Cytomat, Liconic, WDII, PlateLoc, Xpeel, Cytation, Pherastar, Vspin, Echo.

• Ability to work in a multidisciplinary team-based environment.
• Proficient in cellular and biochemical assay techniques.
• Experience with immortalized and/or primary cell culture.
• Knowledge of device networking and communications protocols.
• Experience of scripting and other advanced programming language]]> 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 Mechanical Engineer - II

Join a dynamic team as a Mechanical Engineer - II and play a vital role in supporting cutting-edge manufacturing operations. Based at our facility in Ireland, this full-time, fixed-term position offers the opportunity to contribute to innovative engineering solutions in a collaborative environment. If you are passionate about industrial systems, have a strong technical background, and thrive in a hands-on setting, this is your chance to make a meaningful impact.

What You’ll Do:

• Provide expert engineering support for manufacturing processes, technology, and systems.
• Maintain and repair plant infrastructure and equipment, ensuring optimal performance.
• Collaborate with cross-functional teams to troubleshoot issues and implement improvements.
• Work with moderate supervision, demonstrating independence and technical expertise.
• Apply your experience to support ongoing operations and technology upgrades.

Required Skills:

• Solid understanding of mechanical systems, maintenance, and repair.
• Proven ability to work independently and self-direct tasks.
• Strong problem-solving skills and attention to detail.
• Excellent communication and collaboration abilities.
• Demonstrated understanding of manufacturing or industrial environments.

Nice to Have Skills:

• Experience with systems engineering or automation technologies.
• Knowledge of health and safety standards related to manufacturing.
• Prior exposure to plant infrastructure maintenance.

Preferred Education and Experience:

• Relevant degree or diploma in Mechanical Engineering or a related field.
• Significant experience in manufacturing or industrial engineering roles.
• Experience working in a fast-paced, onsite environment.

Other Requirements:

• Fully onsite role
• Occasional flexibility for WFH, dependent on operational needs.
• Must hold necessary certifications or qualifications pertinent to mechanical engineering support.

Take your career to the next level by contributing your expertise to our innovative team. Apply now to become a key player in our manufacturing success story!
]]> Mon, 23 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 Target Pay Rate: 110-125/hr **salary will be commensurate with experience 

Overview
The Senior Manager is a key contributor within Strategic Feasibility organization, responsible for supporting and advancing high-quality, data-driven feasibility assessments across all phases of clinical development. This role partners closely with Associate Director and Director-level Feasibility Leads to support early indication assessments, study-level feasibility, country and site identification, investigator outreach, and enrollment forecasting, ensuring feasibility insights are translated into clear, actionable inputs for program and study teams.
The role also partners with and supports related Site Management and Feasibility functions, including eTMF Oversight, Site Management, Site Alliances, and Site Contract Management.

Key Responsibilities
Feasibility Delivery & Strategic Support
• Support Associate Director and Director-level Feasibility Leads in the execution of end-to-end feasibility activities across assigned programs and studies.
• Contribute to data-driven early indication and program assessments, including competitive landscape evaluation and operational risk identification.
• Support the development and refinement of study-level feasibility assessments, country and site identification strategies, and enrollment projections.
• Participate in investigator and site outreach activities as needed to inform feasibility assumptions and validate recruitment strategies.
• Contribute to the creation and maintenance of study-level enrollment forecasts aligned with approved operational plans.
• Support feasibility-related deliverables required for governance, program reviews, and internal decision forums.

Broader Operational Contribution
In addition to core feasibility responsibilities, this role contributes to adjacent Site Management and Feasibility activities where feasibility, site readiness, documentation, and startup intersect.
• Support cross-functional initiatives related to site management strategies, early site engagement, startup planning assumptions, and study-level operational risk identification.
• Collaborate with Site Management and Site Alliance Leads on investigator outreach approaches and feedback loops that inform study planning and execution.
• Support review and discussion of site-level risks, gaps, and mitigation strategies in partnership with study teams.
• Support study-specific eTMF oversight activities in collaboration with eTMF Oversight teams, including documentation planning, completeness and quality review, inspection readiness activities, and follow-up on identified issues.
• Support site contract and budget-related activities by contributing country- and site-level assumptions, timelines, and operational execution, including participation in cross-functional discussions related to CTA execution and startup risks.

Qualifications

Education
• Bachelor’s degree required (scientific, medical, or healthcare discipline preferred).

Experience
•?5 years of experience in pharmaceutical, biotechnology, or CRO clinical drug development.
•?2 years of direct experience in feasibility, study planning, site identification, and enrollment forecasting, with exposure to related startup, site management, eTMF, or contract management activities.
• Demonstrated experience supporting clinical operations functions across multiple programs or studies.
• Strong understanding of clinical trial design, execution, and phases of clinical development.

Skills & Competencies
• Strong analytical skills with the ability to interpret data and translate insights into operational recommendations.
• Excellent stakeholder management and communication skills in a global, matrixed environment.
• Ability to work independently while effectively supporting senior feasibility leaders.
• Proficiency with MS Office (particularly Excel and PowerPoint) and relevant analytics and clinical systems/tools.
• Solid understanding of ICH-GCP and the clinical development lifecycle.

Attributes of a Successful Candidate
• Strong attention to methodological rigor and data quality.
• Comfortable operating in a fast-paced, evolving environment with shifting priorities.
• Collaborative, pragmatic, and solutions oriented.
• Detail-oriented with a strong sense of ownership and accountability.
• Demonstrates self-awareness and openness to feedback and continuous development.
• Able to balance strategic thinking with hands-on execution.]]> 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 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
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
  

]]> Sun, 22 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 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.
]]> Fri, 20 Feb 2026 00:00:00 EST 1
Job Details: The role will support the inspection, sampling, and testing of raw materials that are received at the North Carolina (NC) site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.

Primary Responsibilities of the Role Include:

• Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
• Remove samples from containers of medias and other chemicals to facilitate the testing of samples
• Use RAMAN technology with TruScan equipment to identify chemicals
• Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements
• Responsible for accurately documenting inspection, sample, and test results in systems
• Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
• Ability to determine the color of components match required attributes
• Support inspection readiness activities
• Supports Continual Improvement initiatives, programs and projects
• Assist area management with the prioritization and scheduling of tasks
• Serve as a trainer in tasks associated with raw material inspections, samples, and testing
• Own controlled documents for the area including SOPs and FORMs
• Initiate and own deviation records and CAPAs associated with events and projects in ANCs raw material inspections, samples, and testing areas
• Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.]]> Fri, 20 Feb 2026 00:00:00 EST 1 Innovative Quality Manager – Drive Excellence in Food, Environmental, and Beyond
 

Are you a visionary quality professional with a passion for safeguarding standards and continuously elevating laboratory processes? Join a leading Irish contract laboratory dedicated to excellence in microbiology, chemistry, and environmental testing. As our Quality Manager, you will be at the forefront of maintaining and enhancing our Quality Management System, ensuring compliance with the highest regulatory standards while leading strategic initiatives that shape our quality landscape. This pivotal role offers an exciting opportunity to influence critical testing operations and collaborate with a dynamic, growth-focused team in a unique, remote location.

Required Skills:

• Extensive knowledge of ISO 17025, ISO 9001, and INAB accreditation standards
• Proven leadership experience in quality assurance within a laboratory setting
• Strong audit management skills, including internal and external audits
• Expertise in document control, CAPA, and risk assessment processes
• Ability to analyze quality metrics and implement continuous improvement initiatives
• Proficiency with quality management software and MS Office suite
• Exceptional organizational, communication, and interpersonal skills
• Demonstrated experience aligning quality goals with business strategies

Nice to Have Skills:

• Background in Food and Beverage testing, Food and Environmental industries preferred
• Experience with Medical Device and Pharma quality standards
• Knowledge of environmental and food testing regulatory requirements (FDA, EPA)
• Previous involvement in validation, method development, and new technology validation

Preferred Education and Experience:

• Bachelor’s degree in Microbiology, Chemistry, Biology, or related scientific discipline (Master’s preferred)
• At least 5 years in a laboratory quality assurance role
• Minimum of 2 years in a leadership position within a laboratory environment

Other Requirements:

• Willingness to engage in regular stakeholder and client communications
• Ability to manage and coordinate audit schedules and compliance activities
• Flexibility to adapt to evolving regulatory landscapes and industry standards
• This position requires working from our unique laboratory site, which is accessible from Galway within approximately an hour’s drive, with consideration for travel and logistical arrangements given the remote area.

If you’re ready to make a meaningful impact by leading quality excellence and ensuring our laboratories operate at the highest standards, we invite you to apply. Take the next step in your career with us and help shape the future of testing and compliance!
]]> Fri, 20 Feb 2026 00:00:00 EST 1 Senior Financial Analyst – Drive Strategic Impact Through Data and Innovation

Are you a dynamic financial professional with a knack for modeling, analysis, and strategic thinking? Join our client's innovative Digital Technologies Business Unit in London and play a pivotal role in shaping the future of digital, AI, and data-driven surgical solutions. This is your chance to contribute to cutting-edge healthcare advancements while working in a collaborative, forward-thinking environment.

What You'll Do:

• Develop complex financial models to evaluate revenue opportunities, cost savings, and operational efficiencies related to digital health products.
• Analyze industry trends, economic research, and market data to inform strategic decision-making.
• Collaborate across finance, marketing, and business development teams to create actionable insights.
• Lead initiatives to collate market intelligence and support the development of innovative business models.
• Present findings and strategic recommendations to senior leadership, influencing key business outcomes.
• Travel up to 25%, including trips to the US and Europe, to support global collaboration.

Required Skills:

• Bachelor’s degree in Finance, Economics, Accounting, or a related field; MBA or CA designation is a plus.
• At least 2 years of experience in financial planning, business analysis, or related roles within a global organization.
• Expertise in financial statement analysis and business modeling.
• Proficiency in Microsoft Excel, with strong analytical, problem-solving, and logical thinking capabilities.
• Excellent communication skills, with the ability to work independently and in cross-functional teams.

Nice to Have Skills:

• Experience working with digital health or healthcare technology companies.
• Familiarity with data visualization tools or programming languages such as SQL or Python.
• Prior experience in strategic consulting or healthcare innovation projects.

Preferred Education and Experience:

• A bachelor’s degree is essential; advanced degrees or certifications like an MBA or CA are advantageous.
• A minimum of two years in a multinational environment, demonstrating the ability to work across diverse teams and geographies.

Other Requirements:

• Ability to travel internationally, including to the US and Europe.
• London-based with flexibility for hybrid working (3 days on-site).

Elevate your career by joining a company dedicated to transforming healthcare through digital innovation. If you’re ready to leverage your financial expertise to make a meaningful impact, we encourage you to apply now and help lead the future of medical technology.
]]> Fri, 20 Feb 2026 00:00:00 EST 1 POSITION TITLE:
Quality Assurance Technician

SCOPE:
The position of Quality Assurance Technician is vital in assuring that only product meeting defined quality and regulatory standards leaves the manufacturing location. This position requires a detail oriented individual capable of working independently in a clean room environment and meeting the demands of production timelines and commitments.
This position is responsible for:

PRIMARY RESPONSIBILITIES:

• Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.
• Support manufacturing by performing duties such as incoming, in-process, final inspections, DHR completion, product release, etc.
• Authorize release of approved material, intermediates and finished product.
• Prevent release of suspect or known nonconforming products and materials.
• Perform microbiological testing of environment and products as necessary.
• Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices.
• Follow detailed process steps without deviation.
• Organize reports, files, and results in a professional proficient manner.
• Conduct training to Quality Systems processes as defined within the internal learning management system.
• Be flexible and work within a small team without strictly defined roles to assure complete functional coverage.

EDUCATIONAL PREREQUISITES AND SKILL REQUIREMENTS:

• High school degree.
• Fluent in English (read, write and speak).
• Ability to learn and successfully execute tasks such as visual inspection and testing utilizing basic laboratory equipment.
• Previous experience handling chemicals and using basic chemical laboratory equipment preferred but not required.
• Previous experience working in a medical device, pharmaceutical, or other regulated industry preferred but not required.
• Personable, energetic, responsive and confident.
• Strong organization and time management skills.
• Self-starter with the ability to learn and work as part of a team.
• Strong verbal, written, analytical, persuasive skills and ability to interact effectively with all levels.
• Strong interpersonal skills, energetic, proactive, flexible with high integrity and ethics in all dealings.
• Basic office computer skills (email, word processing, and spreadsheet software).

TRAINING REQUIREMENTS:

• Undergo all formal Training Events as may be directed from time-to-time.
• Observe and comply with all 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.

Target Pay Rate Range: $30-40/hr depending on experience 
]]> Fri, 20 Feb 2026 00:00:00 EST 0 Scientist for Biologics and Advanced Therapies - Barcelona

Join our dynamic team as a Scientist for Biologics and Advanced Therapies Analysis and be at the forefront of innovative biologics development in Barcelona! This exciting role is perfect for professionals passionate about method development, validation, and ensuring the highest quality standards for cutting-edge therapies like monoclonal antibodies, recombinant proteins, and more. If you have hands-on experience with HPLC and biologics techniques, and a desire to grow into a senior scientific role, this is your chance to make an impact in a collaborative, fast-paced environment.

Required Skills:

• Bachelor’s degree or higher in Biochemistry, Biotechnology, Pharmacy, or a related field
• 1–2 years of biologics analysis experience (industry or research)
• Proficiency in HPLC and biologics analytical techniques
• Strong understanding of GMP and validation principles
• Excellent communication skills in English (B2 or above)

Nice to Have Skills:

• Experience with other analytical techniques like ELISA or capillary electrophoresis
• Background in GMP or GLP environments
• Prior experience leading validation projects

Preferred Education and Experience:

• Bachelor’s degree or higher in a relevant scientific discipline
• Industry experience in biologics or advanced therapies

Other Requirements:

• Fluency in Spanish and English
• Currently based or willing to relocate to Barcelona (relocation funding not provided)
• Availability for afternoon shifts (13:30–21:30)

If you're eager to contribute to groundbreaking biologics projects and thrive in a collaborative setting, apply now and take the next step in your scientific career!
]]> Fri, 20 Feb 2026 00:00:00 EST 1 Join Our Team as a Senior Real-World Evidence (RWE) Expert – Drive Innovation in Healthcare Research

Are you passionate about leveraging real-world data to inform healthcare decisions? We are seeking a highly skilled and experienced Senior RWE Expert to support cutting-edge epidemiological studies within a dynamic pharmaceutical environment. This home-based opportunity offers flexibility, an engaging role supporting senior colleagues, and the chance to make a meaningful impact on patient populations such as the elderly, pediatrics, and women of childbearing age. If you thrive in a collaborative setting and possess a strong background in RWE, we want to hear from you.

What You’ll Need to Succeed:

• 3-5 years of hands-on experience conducting epidemiological studies within the pharmaceutical industry
• Proven expertise in supporting RWE study design, planning, and execution
• Experience with protocol development and analysis specification
• Excellent written communication skills, capable of providing clear insights and protocol clarifications
• A PhD or MSc in Epidemiology, Outcomes Research, Public Health, or a related field
• Capable of supporting and interpreting RWE insights without necessarily leading projects
• Ability to work independently in a flexible, home-based setting

Nice to Have Skills:

• Experience working with special patient populations such as the elderly, pediatrics, or women of childbearing age (not mandatory but appreciated)
• Prior experience supporting RWE studies across various therapeutic areas and products

Preferred Education and Experience:

• Advanced degree (PhD or MSc) in Epidemiology, Outcomes Research, or Public Health
• 3-5 years of relevant industry experience, ideally supporting epidemiological and RWE initiatives in pharma

Other Requirements:

• Availability for a flexible start date, with potential for full-time six-month engagement or part-time support until year-end
• Ability to work remotely within the UK
• Successful completion of two interview rounds

This is a unique chance to join a forward-thinking team that values expertise and innovation. If you’re ready to contribute to meaningful healthcare research and advance your career, apply now and become part of a transformative project supporting real-world evidence in pharma.
]]> Fri, 20 Feb 2026 00:00:00 EST 1 A leading research?driven organisation is growing its cloud and data engineering capability and is hiring a Cloud & Data Platform Engineer to support the development, governance and optimisation of its modern Azure?based environment. This role is ideal for someone with early career experience in cloud/data engineering who is ready to take ownership of real platform responsibilities.

---

The Role
You will support the build and optimisation of a scalable data and ML platform, working across Azure, Snowflake and a range of modern engineering tools. The position blends technical platform work with governance responsibilities, ensuring Azure environments remain secure, compliant and cost?efficient.

This is not a senior architecture role — it is hands?on engineering and cloud administration, contributing directly to how the organisation uses its cloud services.

---

Key Responsibilities Cloud Engineering & Administration

• Act as a global administrator within Azure, supporting identity, governance and platform configuration
• Apply, maintain and improve Azure policies, including cost monitoring, optimisation and resource governance
• Support automation, monitoring and operational upkeep of cloud services

Data Platform Engineering

• Work with Snowflake as part of the core enterprise data platform
• Contribute to data pipeline creation, integrations and ongoing platform health
• Support ML/data workflows using tools such as Databricks, Azure ML, Synapse, MLflow, Airflow, or similar technologies

Collaboration & Platform Support

• Work closely with data engineers, ML practitioners and analysts
• Troubleshoot and resolve cloud platform issues
• Help shape best practices for cloud operations and cost?effective design

---

What We're Looking For

• Around 2–3 years’ experience in cloud engineering or data engineering
• Strong experience working with Azure (AWS familiarity fine, but Azure must be primary)
• Hands?on experience with Snowflake is a plus
• Familiarity with modern data/ML platforms (Databricks, Azure ML, Synapse, MLflow, Airflow, etc.)
• Experience applying Azure policies, managing cloud governance and monitoring cloud cost efficiency
• Experience acting as an Azure global administrator, overseeing core platform configuration
• Broad engineering mindset — someone who works on platforms, not analysing data

]]> Fri, 20 Feb 2026 00:00:00 EST 1 Job Title: Pharmacovigilance (PV) Associate
Location: Japan
Focus: Pharmaceuticals

Role Overview

A regulated pharmaceutical organisation is seeking a Pharmacovigilance (PV) Associate to support its drug safety and pharmacovigilance operations in Japan. This role is responsible for supporting the local pharmacovigilance system, ensuring timely processing of adverse events, safety surveillance, and compliance with Japanese and global regulatory requirements.

The position plays a key operational role in maintaining patient safety, regulatory compliance, and high-quality safety data across marketed products.

Key Responsibilities 1. Adverse Event (AE) Case Processing

• Monitor and receive Individual Case Safety Reports (ICSRs) via the PMDA ICSR Reception Site
• Review, assess, and process adverse event reports related to pharmaceuticals (and, where applicable, medical devices)
• Ensure timely and accurate submission of ICSRs to PMDA in accordance with regulatory timelines
• Collect and process AE information from multiple sources, including healthcare professionals, patients, and literature
• Perform follow-ups to obtain additional or missing case information
• Prepare and manage XML files for regulatory submissions
• Submit applications and XML data via PMDA systems
• Maintain accurate documentation and compliance records

2. Data Entry & Quality Control

• Enter case data accurately into pharmacovigilance databases
• Perform MedDRA coding verification for reported adverse events
• Conduct quality checks to ensure data consistency and regulatory compliance

3. Medical Literature Monitoring

• Conduct routine literature searches using recognised Japanese literature services
• Document search results in tracking tools
• Identify relevant safety signals and escalate findings appropriately

4. Systems, Processes & Documentation

• Maintain and update internal project trackers to ensure real-time visibility of case status and deliverables
• Support the development and maintenance of work instructions and SOPs
• Perform QC of pharmacovigilance and regulatory documentation

5. Communication & Cross-Functional Coordination

• Respond to internal inquiries related to safety data
• Coordinate closely with Safety Management and cross-functional stakeholders
• Participate in team meetings and provide updates on case handling and workload

6. Regulatory Reporting & Compliance

• Support preparation and submission of regulatory safety reports, including ICSRs and periodic safety reports, in line with PMDA requirements
• Support quality control and translation of pharmacovigilance and regulatory documentation

7. Medical Information Support

• Support medical information activities, including call intake where required
• Review, update, and maintain medical information materials
• Support development and review of PI, RMP, and IF documentation

Candidate Profile

• Bachelor’s degree or higher in Pharmacy, Medicine, Life Sciences, or a related discipline
• Minimum of 3 years’ experience in pharmacovigilance, drug safety, or a related regulatory function
• Familiarity with Japanese pharmacovigilance systems and tools used for ICSR preparation, signing, and submission
• Strong understanding of Japanese regulations (GVP, GPSP) and global safety guidelines (ICH, FDA, EMA)
• Experience working with pharmacovigilance databases and safety surveillance activities
• Strong attention to detail with excellent organisational and time-management skills
• Native-level Japanese (written and verbal preferred)
• Strong written English skills

Reporting & Collaboration

• 
  Reports to Pharmacovigilance leadership in Japan
  
• 
  Works closely with internal stakeholders including Regulatory Affairs, Quality Assurance, and Medical Affairs
  

]]> Thu, 19 Feb 2026 00:00:00 EST 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, 19 Feb 2026 00:00:00 EST 0 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, 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
Summary:
The primary responsibility of the Clinical Data analyst is to support CDM study startup activities, including developing database specifications, authoring and executing test scripts, and preparing key CDM deliverables.

Key Responsibilities:
• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
• Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), CRF completion guidelines, training materials and user aids in compliance with regulations.
• Perform Site/User Administration including generating and validating EDC reports and Subject PDFs.
• Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
• Assist in leading project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.
Skills:
• Experience with Medidata EDC (Electronic Data Capture) systems required. Experience with InForm EDC system preferred.
• Good computer skills in Microsoft Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills

Education and Experience:
• Bachelor's Degree or equivalent
• 5-7 years of experience required]]> Thu, 19 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
• 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
 ]]> Thu, 19 Feb 2026 00:00:00 EST 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]]> Thu, 19 Feb 2026 00:00:00 EST 1 About the Role
Join our Biologics Pilot Lab and contribute directly to the development, scaleup, and pilot-scale production of early and late-stage biologic programs. In this role, you will execute downstream purification operations, support upstream activities as needed, and help advance programs that are central to the companies biologics pipeline. This position is ideal for candidates who are hands-on in the lab, collaborative, and excited to work on fast moving development efforts.

Key Responsibilities

Technical & Operational
• Plan and execute downstream purification and scale-up activities including filtration, chromatography, and buffer preparation.
• Support upstream operations as needed to ensure seamless end-to-end process execution.
• Monitor, analyze, and interpret process and performance data; prepare clear summaries of findings as appropriate.
• Maintain laboratory readiness, including equipment maintenance, analytical instrument upkeep, consumable inventory management, and general lab support.

Communication & Collaboration
• Present data, results, and conclusions in group meetings and cross functional discussions.
• Communicate technical information clearly and effectively to colleagues at varying levels.
• Work with a team-oriented, collaborative, and solutions-focused mindset.
• Maintain a strong safety focus in all laboratories and pilot operations.

Required Qualifications
• Hands-on experience with downstream purification operations, including centrifugation, chromatography, TFF, and depth filtration.
• Proficiency with AKTA systems and UNICORN programming.
• Practical experience in chromatography column operations, including resin packing and unpacking at various scales (e.g. 4.4 to 30 cm internal diameter columns).
• Strong verbal communication, technical writing, and documentation skills.
• Ability to work effectively in cross functional teams and in a dynamic environment.
• Self-motivated, organized, and comfortable with scientific problem solving.---

Preferred Qualifications
• Experience in pilot plant operations for biologics in a single-use facility.
• Familiarity with Process Development and/or current Good Manufacturing Practices (cGMP), technology transfer, plant operations, and bioprocess scaleup principles. 

Education
• AA/AS degree with 2+ years of relevant industry experience (purification techniques), or
• BS/BE in Chemical/Biochemical Engineering, Biochemistry, Biology, or related discipline with 1+ year of relevant experience.

Work Requirements
• This is a 100% onsite role in Foster City, CA.
• Occasional weekend work required to support pilot-scale biologics operations.

Pay ranges between35-41/hr based on experience ]]> Thu, 19 Feb 2026 00:00:00 EST 1

Develop and maintain all project documentation (Project Plan, Issue and Action Logs, Risk Management, Communication Plan, Status Reports, ...etc.).

Maintain the Project Management Office Library with lessons learned database, and apply lessons learned to all initiatives.

Assist in the development and implementation of templates, procedures and processes as part of the continuous improvement process.

Responsible for managing all aspects of the project management life cycle including project scoping, resource assignment, project plan development, project tracking, monitoring and reporting.
Qualifications include:

• Demonstrated experience in project management delivering project solutions;
• Experience in managing multiple projects at a time;
• Expert in using MS Suite including Microsoft Project;
• Knowledge of proven industry best practices and standards;
• Project Management designation an asset but not required.

Hybrid opportunity post initial training possible.
Start/End Time Flexible between 7 to 9 AM and 3:30 to 5:30 PM





Pay Rate Range: $35-46/hr depending on experience ]]> Thu, 19 Feb 2026 00:00:00 EST 1
TASKS / PROJECT RESPONSIBILITIES
• Liaise with reporting team and clinical project teams, as needed, to gather clinical report and data listing needs and requests to ensure that all of the report/data requirements are clearly understood and meet the requestors requirements.
• Participate in the requirement collection, design, development, unit testing, user acceptance testing and maintenance of clinical study reports, and data deliverables for multiple clinical studies (databases) according to the department SOPs.
• Develop reports and dashboards using Power BI Desktop, MS Fabric and PBI Service.
• Liaise with the Report Development and Validation team to ensure report deliverables are released in accordance with rules and regulations and in corporate compliance.
• Liaise with Clinical IT, IT to address and resolve technical issues.

EXPERIENCE (Required and/or preferred work experience)
Required:
• 5+ years developing reports and Dashboards using Power BI Desktop, Power BI Service, Power Query, Power Query M, and DAX, SQL or equivalent BI technology
• Experience with data modeling, data transformation, and data visualization
• Knowledge of SQL and ability to write moderately complex queries
• 5+ years liaising with customers and documenting report requirements
• Proven ability to produce complex clinical study reports using Power BI
• Adherence to department SOPs and a regulated environment
• Good organizational skills and ability to adapt to changing priorities a must.
• Good communication skills - the ability to enable both technical and non-technical
• Ability to work independently and in a team environment on assigned projects within department required
• Excellent problem-solving skills, a proactive approach, and a willingness to make decisions on a regular basis and communicate these clearly required

Preferred:
• 3+ years in another major reporting tool (Tableau, Cognos, SQL Server Reporting Service, Oracle Reports, Spotfire, etc.)
• 1+ years working knowledge of the Medidata Rave EDC system or other EDC system (InForm, Oracle Clinical).
• Knowledge of clinical research processes, clinical data processing practices, relational database fundamental preferred

EDUCATION (Required and/or preferred degrees or other educational qualifications)
• Required: B.S Computer Science, Information System, or related discipline. If bachelors degree in non-related discipline, required 7 years working as POWER BI Programmer.]]> Thu, 19 Feb 2026 00:00:00 EST 1 Target Pay Rate: 55-65/hr **salary will be commensurate with experience 

Qualifications: 
Support implementation of strategies to demonstrate the unmet need in disease with focus on outcomes meaningful to payers, clinical decision-makers, and regulators
Assist with research to generate evidence necessary to demonstrate product differentiation and value for commercial/market access needs support clinical development, regulatory and safety needs (real-world evidence and epidemiology studies)
Assist in projects and management of external partners/vendors in the execution of CORE projects
Engage with cross-functional teams in development, commercial, market access, safety, legal and medical affairs as required
Support execution of communication/publication strategies for given product & for publication/presentation of research outcomes at scientific conferences and forums

Responsibilities:
As a member of the CORE – RWE analytics team, the contractor RWE Sr Manager/Programmer will be responsible for execution of RWE studies and communicating study results to internal stakeholders in RWE, building RWE data visualization tools, and support presentation/publication of study results. This role will align with the RWE TA lead to conduct timely, relevant and rigorous analysis of RWD to address critical research questions, it requires strong hands-on experience with statistical programming and large healthcare datasets.

Responsibilities will include, but are not limited to, the following:
- Extract raw data from servers and conduct statistical analyses based on protocol specifications using real-world data (RWD).
- Work with RWE researchers to develop code lists for new measures, creating data specification files and analytical files by writing and executing programs across our available observational databases
- Conduct quality assurance and code validation, review programming code and data
- Draft analysis reports and support the final publication/presentation of results.
- Develop visualization and automation tools using secondary data sources (Real World Data, Systematic/Targeted Literature Review Data).

Requirements:
- A graduate degree in Epidemiology, Biostatistics, Public Health, Informatics, or another related field.
- At least 3 years of post-graduation experience in statistical programming in SAS or R, and database programming in SQL or Python, demonstrated proficiency in statistical analysis programs commonly used in life sciences.
- Working experience with data visualization tools for dashboard (R-shiny, Power-BI, Excel, etc.)
- Basic therapeutic area knowledge in oncology (solid tumor and hematology), knowledge of US secondary data sources required, additional experience with international data sources is preferred.
- Experience in observational research study design, execution, and communication, track record of analysis of a broad range of RWD, understanding of epidemiology or outcomes research and the application of retrospective or prospective studies to generate value evidence.
- Agility to work effectively in a fast paced, constantly changing, diverse and matrix environment
- Knowledge in epidemiologic and statistical concepts commonly used in life science, such as confounding, bias, cumulative incidence, incidence rate, regression models, survival analyses, propensity score matching, etc.
- Strong written and verbal communication skills.
- Strong teamwork skills and ability to collaborate well with team members.
 ]]> Thu, 19 Feb 2026 00:00:00 EST 1
Serve as the primary operational partner to the Associate Director, Curriculum Strategy, Experience, and Design by organizing portfolio data, maintaining lifecycle oversight, and preparing information that supports informed decision making

Ensure learning portfolio components are consistently structured, documented, and aligned with established governance standards, SOPs, and operating principles.

Coordinate internally across learning operations, LMS operations, learning effectiveness, and design teams to maintain portfolio integrity, data accuracy, and system alignment

Maintain lifecycle transparency including content evolution, expiration, retirement, and updates to support compliance, audit readiness, and operational continuity
Support ongoing operational maturity by improving portfolio visibility, consistency, and readiness for future enhancements, measurement, and technology enablement

Pay ranges between 35-43.50/hr based on experience ]]> Wed, 18 Feb 2026 00:00:00 EST 1

0-2 years of experiences with testing and data analysis, creating test protocols and reports.

• 0-3 years of medical / clinical experience or exposure

Advanced Testing Knowledge

Packaging Testing
Nice To Have

• Basic laboratory mechanical testing skill
• Calibration

Responsibilities may include the following and other duties may be assigned. Sets up test apparatus and conducts tests of production assemblies and units following methods, procedures, standards, and sequences. Lays out and assembles units for production equipment according to designs and specifications. Adjusts and calibrates systems as needed. Modifies equipment by adding, removing, or altering components as defined by predetermined diagrams and sketches. Corrects malfunctions by making adjustments or replacing parts or components as directed. Uses hand and small power tools, and various measuring and testing devices in performing job duties. May monitor and verify quality in accordance with statistical process or other control procedures.

TECHNICIAN SUPPORT CAREER STREAM: Provides technical support in areas such as production, operations, maintenance, safety, testing, process improvement or product development. Uses schematics, diagrams, written and verbal descriptions or defined plans to perform testing and troubleshooting on electronic or mechanical components, equipment or systems. Gathers, maintains, formats, compiles, and manipulates technical data using established formulae and procedures, and performs detailed mathematical calculations. For higher levels, may suggest and/or make improvements to optimize work processes.

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor, working under moderate supervision . Performs tests, interprets data and develops reports.

Organizational Impact: Performs intermediate technical activities requiring judgment and decisionmaking . Work consists of technical tasks that are typically routine.

Innovation and Complexity: Technical problems faced are generally routine, but may require interpretation of procedures or policies to resolve problems . May be required to highlight areas of concerns/problems in own job area.

Communication and Influence: Communicates typically with internal contacts . Obtains and provides technical information requiring some explanation or interpretation .

Leadership and Talent Management: May provide guidance and assistance to new or entry level employees.

Required Knowledge and Experience: Requires basic job knowledge of systems, techniques and procedures obtained through prior work experience or education. Requires minimum of 2 years of relevant experience; may require vocational or technical education or certification in addition to prior work experience.]]> Wed, 18 Feb 2026 00:00:00 EST 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!

 ]]> Wed, 18 Feb 2026 00:00:00 EST 1

This company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. This company will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, the General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
Background
The company's Global Finance operations continue to grow rapidly with the overall company and are developing into a leading-edge global finance organization. The company has over $3 billion of annual revenues and operations in 40 plus countries that drive a fast-paced and dynamic team environment, along with operational complexity. The company has ambitious growth plans and has an enthusiastic global team that is eager to deliver world-class accounting and finance services to the company and its stakeholders.
Position Summary
Reporting to the Senior Treasury Manager, this position will support across the Treasury function, including critical treasury operations, FX back office and M&A integration workstreams. This role will require someone with multi-national corporate treasury experience who is highly technical, hands-on, detail oriented, with strong organizational and communication skills. The ideal candidate would be someone knowledgeable across all aspects of corporate treasury function. This role is based in the San Rafael offices, on a hybrid basis.

Bank Infrastructure and Services
• Maintain a best in class worldwide banking infrastructure. Collaborate with the International Treasury team to align banking goals and strategies.
• Ensure high levels of service are provided to corporate business partners and opportunities for efficiencies are identified and evaluated.
• Support best-in-class initiatives around fraud prevention, risk mitigation, straight through processing, governance and global liquidity management.
• Support regulatory compliance, including FBAR and KYC.

SAP Support
• Engage and learn the Company’s SAP MBC treasury workstation, including the Cash Flow Analyzer, payments processes and any new modules.
• Adheres to standards and procedures for project reporting and documentation.
• Performs other related duties as required.

Cash Management, Cash Forecasting and Additional Support
• Support the company’s short-term liquidity forecast utilizing bank systems and SAP.
• Maintain a strong daily cash positioning template. Create and release EFTs as appropriate
• Support the FX Back Office, including wire settlements.
• Monitor intercompany balances, help plan and manage intercompany trade and loan settlements.
• Monitor Treasury operational policies, oversee SOX compliance and support internal and external audit requirements.

Required Skills
• Strong understanding of treasury operations, corporate banking practices
• Experience using treasury workstations (SAP-preferred), risk management systems (FXall, CapellaFX, Clearwater) and various bank and investment portals (CitiDirect, BOA CashPro, JPM Morgan Money)
• Experience managing multiple projects simultaneously
• Desire to share knowledge in a cooperative fashion, to be a team player
• Excellent communication and organizational skills
• Strong work ethic, attention to details, ability and willingness to work effectively independently as well as part of a team
• 7+ years of experience in multi-national Corporate Treasury department
• University degree in Business, Accounting or Finance
• Treasury Qualification (CTP) is a plus



Work Environment/Physical Demands
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.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Equipment:
Computer skills including Excel, Word, Power Point, G/L and financial reporting systems (Oracle and HFM), Treasury Management Systems, Bank Portals
Contacts:
Interaction with Corporate Accounting, Global Controllership and Regional Finance, FP&A, Bank Partners
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. ]]> Wed, 18 Feb 2026 00:00:00 EST 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  ]]> Wed, 18 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
We are seeking a highly motivated Research Associate to join our Target Discovery team focused at the interface of immunotherapy and genomics research. This position will work hands-on with primary human tissues and cutting-edge single-cell technologies to support discovery and validation of novel therapeutic targets. The role offers exposure to the full pipeline – from tissue banking and processing to single cell genomics and experimental validation.  This is an ideal opportunity for a recent graduate seeking industry research experience in immunology, cancer biology, or single-cell genomics.
Key Responsibilities:
• Coordinate, receive, and bank fresh human tissue samples from CROs and external partners.
• Organize, track, and manage tissue samples stored in LN2, ensuring accurate inventory and documentation.
• Perform dissociation of fresh primary human tissues into single-cell suspensions using
enzymatic and/or mechanical methods.
• Execute single-cell RNA-seq workflows, including cell preparation, FACS, and library
preparation.
• Set up, operate, and maintain flow cytometry instruments and cell sorters.
• Maintain and expand cell lines using sterile cell culture techniques
• Perform target antibody screening workflows using flow cytometry, ELISA, Western blotting, and related methods.
• Analyze and document experimental results; contribute to internal datasets and presentations.
• Collaborate with computational and translational scientists to interpret data and support
identification of candidate therapeutic targets.

Qualifications:
• B.S. or M.S. in biological sciences or a related field (immunology, cancer biology, molecular biology, biochemistry, cell biology, and/or bioengineering).
• Highly organized, detail-oriented, and comfortable managing biological samples and associated metadata
• Hands-on experience with wet-lab techniques, such as mammalian cell culture and sterile technique
• Familiary with primary tissue handling, tissue dissociation, or single-cell workflows is a plus
• Familiarity with FACS and/or flow cytometry
• Strong attention to detail and ability to follow complex protocols
• Ability to work independently while contributing to a collaborative team

What You’ll Gain:
• Direct, hands-on experience with primary human tissues, single-cell genomics, and novel therapeutic target biology
• Exposure to real-world therapeutic target discovery and validation in an industry setting
• Mentorship from experienced scientists and opportunities to present your work
• A front-row seat to how cutting-edge biology translates into drug development

 ]]> Wed, 18 Feb 2026 00:00:00 EST 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:
• 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.

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).

Education/Experience:
• Bachelor's degree in engineering required.
• 2-4 years experience required.]]> Wed, 18 Feb 2026 00:00:00 EST 1 The NRD Medical Director will provide exceptional clinical and scientific leadership for medical affairs activities, with a major focus on evidence generation/medical monitoring.
The successful candidate will leverage their extensive experience in late phase clinical development to bridge scientific insight with clinical execution to ensure that studies are medically sound, ethically conducted, and scientifically meaningful, producing evidence that informs real-world practice, supports product value, and enhances patient care.

Key Responsibilities

• Evidence Generation/Medical Monitoring
• Contribute clinical expertise to assess unmet needs, evolving treatment landscape and evidence gaps in the area of neurological rare diseases.
• Align study execution with broader evidence-generation plans, real-world data strategies, and publication objectives.
• Serve as the primary medical voice and represent the medical/scientific perspective within the Study Management Team (SMT), working closely with all functions in the team.
• Provide clinical oversight to ensure the medical and scientific integrity of the study conduct, including adherence to the protocol, medical input to study deviations or amendments, and clinical impact of any protocol deviations or proposed changes.
• Collaborate with the Global Safety Team lead to review safety data.
• Address medical questions from investigators or internal teams, ensuring timely and accurate responses.
• Lead the interpretation of clinical outcomes in the context of the disease and standard of care, in close collaboration with the SMT and NRD medical team.
• Contribute to abstracts, manuscripts, and congress presentations, ensuring accuracy and scientific balance.
• Support data communication to internal and external stakeholders (e.g., field medical teams, healthcare professionals).
• Ensure all activities adhere to company policies and applicable regulatory standards.
• Identify and mitigate clinical or ethical risks during study execution.
• Support regulatory or internal audits from a medical perspective.

Additional Responsibilities

• Scientific Engagement: Contribute to broader Medical Affairs activities, including providing a clinically meaningful perspective for regulatory and other scientific communications, and engaging with company's internal and external stakeholders.
• Cross-Functional Leadership: Represent the US Medical function within cross-functional teams and initiatives within the global organization.
• This position requires flexibility in prioritizing work, and a mindset to engage in purposeful partnerships to achieve our medical strategies.
• Compliance: Act as a guardian for high standards of compliance, ethics, and safety, putting patients at the center of all actions.

Who you are

• MD is required.
• Minimum 6+ years of relevant biopharmaceutical industry experience.
• Experience with later phase clinical development (eg, phase 3-4, and observational studies), including minimum 3+ years of relevant medical monitoring.
• Experience with Spotfire or similar data visualization and analytics platform used in clinical research and medical monitoring.
• Understanding of the US health care environment, including the payer landscape, marketplace factors/dynamics, evidence-based medicine tools and practices.
• Experience in other areas of Medical Affairs such as scientific communications and external engagement.
• Exceptional clinical judgment, outstanding communication and presentation skills, and the ability to lead and influence in a complex matrix organization.
• Proven record in developing strong relationships with external stakeholders (eg, therapeutic area experts, external organizations).
• Great team player; Highly collaborative; good interpersonal and influencing skills; can effectively and quickly establish rapport and influence without authority.

Pay Rate Range: $70-94/hr depending on experience 

 ]]> Wed, 18 Feb 2026 00:00:00 EST 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

]]> Wed, 18 Feb 2026 00:00:00 EST 1 *Depending on experience

Our Senior Supplier Development Engineer position is a unique career opportunity that could be your next step towards an exciting future.
The Senior Supplier Development Engineer role will reside in the Advanced Technology (AT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds and commercialization of new product introduction. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Support manufacturing readiness reviews, supply chain readiness review and manage design transfers to manufacturing.

How you'll make an impact:
Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and receiving inspection fixture design for Test method validation.
Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively
Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.
Develop and manage project milestones in line with development and commercialization needs.
Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
Audit suppliers for their technical capabilities as well as quality criteria.
Perform other duties and responsibilities as assigned.

What you'll need (Required Qualifications):
Bachelor's Degree or equivalent in Engineering or Scientific field with, 4 years experience including either industry or industry/education OR
Master's Degree or equivalent in Engineering or Scientific field with, 3 years experience including either industry or industry/education.
On-site work required.
Up to 20% domestic/international travel required.
What else we look for (Preferred Qualifications):
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
Experience in catheter manufacturing technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
CAD experience using ProE/Solidworks
Strong analytical, problem solving and technical writing skills.
Strong Project management skills.
Ability to work well both independently and as a member of a team.
Effective verbal/written communication and interpersonal skills including conflict and relationship management.]]> Tue, 17 Feb 2026 00:00:00 EST 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

]]> Tue, 17 Feb 2026 00:00:00 EST 1 Location
Brisbane & wider QLD region (field?based)
Sector
Hip & Knee Reconstruction (Implants)

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The Role
A growing med?tech organisation is introducing a new Orthopaedic reconstruction portfolio in Australia and is looking for a Territory Manager to establish and grow the business across Brisbane. You’ll operate as the lead representative for Hip & Knee implants in the region, supported by a national team already working in another product division.

---

Your Focus
Territory Growth

• Build visibility for Hip & Knee reconstruction across hospitals in Brisbane and surrounding areas
• Develop trusted relationships with surgeons and theatre staff
• Support cases and provide product education

Commercial Ownership

• Manage territory planning, revenue development and account strategy
• Work with procurement teams and hospital stakeholders
• Coordinate with channel partners or distributors where relevant

Market Insight

• Track procedure volumes, trends and competitive movement
• Maintain structured knowledge of hospitals, decision?makers and market shifts

Compliance & Conduct

• Operate ethically and in line with organisational and local guidelines

---

You Bring

• Minimum 3 years’ experience selling Hip & Knee implants
• Recent operating theatre exposure
• Strong relationship?building skills with surgeons and hospital teams
• Confidence working autonomously and managing territory growth
• Experience with distributor or agent partnerships is beneficial

]]> Tue, 17 Feb 2026 00:00:00 EST 1 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 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, 17 Feb 2026 00:00:00 EST 1 Validation Engineer II – (Hybrid Role)

Step into a pivotal role that drives excellence in quality assurance within the biotech or pharmaceutical manufacturing sector. As a Validation Engineer II based in Carlow, you will be at the forefront of ensuring the integrity and compliance of critical equipment and sterilization processes. This is a fantastic opportunity to apply your technical expertise in a dynamic, collaborative environment, supporting key validation projects that contribute to life-changing innovations.

What You’ll Bring to the Table:

• A strong background in engineering or science, with proven experience in equipment validation and sterilization validation.
• Excellent technical writing abilities, paired with clear and effective oral communication skills.
• Demonstrated experience in developing validation master plans, SOPs, protocols, and final reports.
• Skilled in executing validation studies and analyzing data to resolve technical challenges efficiently.
• Ability to work both independently and within cross-functional teams, managing validation projects with moderate supervision.

Nice to Have Skills:

• Experience with pharmaceutical or biotech manufacturing environments.
• Knowledge of regulatory standards and compliance requirements related to validation activities.
• Familiarity with sterilization methods, cleanroom procedures, or GMP guidelines.

Preferred Education and Experience:

• Bachelor’s degree in Engineering, Science, or a related field.
• Prior experience in equipment and sterilization validation, ideally within a regulated industry.

Other Requirements:

• Ability to work in a hybrid setting
• Strong attention to detail and organizational skills to manage multiple validation activities effectively.

If you’re ready to contribute your expertise to a role that makes a real impact, we encourage you to seize this opportunity and apply now. Make your next career move in validation excellence!
]]> Tue, 17 Feb 2026 00:00:00 EST 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

]]> Tue, 17 Feb 2026 00:00:00 EST 1 *depending on experience

Construction Manager -- NC
The Construction Manager will lead large-scale capital investment and site master plan initiatives within an active manufacturing environment. This role provides technical leadership across project management, construction execution, and operational readiness. You’ll be responsible for ensuring safe, high-quality delivery of complex projects while supporting long-term asset reliability and site performance objectives. The construction portfolio is approximately $100M in value.

Responsibilities
• Direct and oversee construction delivery teams, including internal project stakeholders, third-party construction management partners, and construction safety resources.
• Manage assigned construction scope to ensure safe execution, quality workmanship, and functional outcomes through hands-on, daily oversight of field activities.
• Collaborate with on-site engineering, design teams, system owners, and project engineering services to achieve construction milestones.
• Monitor daily field progress, proactively address site issues, and remove execution barriers.
• Review, assess, and resolve construction change notices as they arise.
• Drive schedule adherence by actively engaging field teams and leveraging site-based tools and collaboration systems.
• Maintain a strong construction safety culture aligned with internal safety standards and expectations.
• Lead coordination of construction activities that interface with existing operations, including implementation of clean construction practices.
• Review monthly cost reports and payment applications submitted by construction management partners.
• Partner with project controls to evaluate change requests, review invoices, and support monthly reporting.

Accountability & Reporting
• Provide weekly updates on construction progress, risks, and key milestones.
• Deliver monthly reporting on project financials, schedule status, and risk profile.
• Develop and maintain an integrated project schedule covering design, construction, commissioning/qualification, validation, and system turnover.
• Coordinate with external vendors, consultants, municipal authorities, and local utility providers as required.
• Ensure proper turnover of construction documentation, test records, materials, and certifications.
• Support development of SOPs, preventive maintenance schedules, and quality documentation for installed electrical assets.

Required Education and/or Qualifications
• Bachelor’s degree in Engineering or comparable technical experience.
• Minimum of 10 years of engineering experience, including at least 5 years managing capital construction projects.
• Strong knowledge of pharmaceutical construction practices and regulated manufacturing environments.
• Hands-on experience with pharma and biologics packaging facilities, equipment and packaging line installations.

Other Requirements
• Background in pharmaceutical manufacturing engineering across operations, maintenance, or capital project execution.
• Working knowledge of hygienic design principles, cleanroom electrical standards, and validation requirements.
• Solid understanding of the end-to-end project execution lifecycle.
• Experience using project management and scheduling tools, including web-based collaboration platforms.
• Willing to travel on average 20-50%, with extended on-site presence during active construction phases]]> Tue, 17 Feb 2026 00:00:00 EST 1
Responsibilities
• Execution of cell-based functional and biochemical assays to select candidate molecules for clinical development or support combination strategies to enhance T cell product potency and safety
• Experimental design aimed to address basic tumor immunology aspects related to the immunosuppressive tumor microenvironment
• Genetic/biochemical manipulation of T cells and evaluation of impact on T cell function
• Analyze, organize and communicate results at different research and cross-functional meetings
• Plan and effectively execute experiments based on strategy, project timelines and goals
• Analyze and present scientific results to the project team in addition to cross-functional and cross-site audiences
• Document experimental results to enable subsequent clinical studies and patent applications
• May serve as a core team member or leader on a project team
• Work effectively with other functions (including Process Development, Translational Medicine, Clinical Development) to ensure alignment cross-functionally
• Coordinate tasks across multiple projects, demonstrating prioritization and planning
• May mentor junior team members and supervise the work of a research team including, but not limited to, organizing and prioritizing laboratory work and review of generated experimental results

Basic Qualifications
Advanced scientific degree (i.e. MD, PharmD, PhD)
OR
Masters Degree and 6+ years of scientific experience

Preferred Qualifications
• Experience designing and developing primary immune cell assays using key immune cell populations
• Hands-on expertise in T-cell functional characterization assays including in vitro cxytotoxicity, proliferation, cytokine/chemokine measurements, cell signaling, activation, differentiation and exhaustion
• Proficient in cell culture aseptic technique
• Proficient in multi-parameter flow cytometry (panel design, sample acquisition, data processing) and data analysis (FACSDiva, FlowJo, GraphPad Prism, Excel)
• Experience with MSD/ELISA and/or Luminex
• Ph.D. degree in biology-related field (immunology, cellular and/or tumor biology or a closely related field)
• A strong background in cancer immunotherapy and human immunology, experience working with engineered T cells strongly preferred
• Demonstrated independence in experimental design, data analysis, interpretation, and presentation
• Maintain a high degree of accuracy and attention to detail
• Drive to learn and make a meaningful impact
• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
• Strong collaboration, excellent interpersonal and communication skills
• Experience using both written and verbal communication, including presentations, to communicate results to a diverse cross-functional audience
• Strong organizational and record keeping skills
• Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description

Pay ranges between 65-71/hr based on experience  ]]> Tue, 17 Feb 2026 00:00:00 EST 1 Position: Vice President
Location: Tokyo (office-based)
Employment Type: Permanent, Full-Time
Direct Reports: Operations Team

Company Overview
The client is a global pharmaceutical and life sciences benchmarking and advisory firm, operating across multiple continents. The organisation supports pharmaceutical and biotech clients through a highly specialised, data-driven benchmarking and audit methodology, built on a large global database of face-to-face observations and performance metrics. Their work focuses on accelerating performance and improving strategic alignment across commercial, medical, market access, and account planning execution. Due to the niche nature of their offering and strong client demand, the business is in a high-growth phase, creating opportunities for senior leaders to play a key role in shaping operations and scaling delivery capability.

Role Purpose
This role acts as both a strategic partner and operational leader to the Japan Country President. As the Japan business continues to expand its service offering and delivery scope, this individual will lead operational excellence, aligned closely with global operations.
A core part of the role is building and strengthening project delivery capability, developing team members, and ensuring high-quality execution across client engagements as the organisation moves into its next phase of growth.

Key Responsibilities

• Provide operational leadership and direction to Project Management, Analysis, and Field Operations teams.
• Partner with the Japan Country President on P&L oversight, including participation in quarterly business reviews and monthly leadership meetings.
• Support annual forecasting and business planning processes for the Japan business.
• Work closely with Global Operations leadership to align on best practices, processes, standards, and systems, driving consistency and efficiency across the organisation.
• Collaborate with the Global Client Partnership team and delivery teams to manage senior client relationships, with a focus on client satisfaction and operational quality.
• Step in to lead project delivery where Project Directors or Project Managers face capacity constraints. This includes:
  • Brand performance analysis and hypothesis development
  • Sense-checking workbooks and outputs with clients
  • Project brief and debrief preparation and refinement
  • Delivery of final client presentations

Essential Skills & Experience

• Background in in-house pharmaceutical sales management, marketing leadership, business unit leadership, or management consulting, with strong senior-level client exposure.
• Experience operating at a senior leadership level, including people development, coaching, and performance management.
• Commercially minded and results-focused, with the ability to support business growth and client retention.
• Strong interpersonal and communication skills, able to adapt style to different audiences and clearly “tell the story” behind insights.
• Credibility and confidence engaging with senior stakeholders within client organisations.
• Comfortable working independently while leading and developing teams.
• Demonstrates gravitas, judgement, and the ability to challenge constructively and deliver practical solutions.

]]> Tue, 17 Feb 2026 00:00:00 EST 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

]]> Tue, 17 Feb 2026 00:00:00 EST 1 Validation Engineer - III

Are you a seasoned validation professional ready to make a meaningful impact in a dynamic environment? We are seeking a highly skilled Validation Engineer - III to join a forward-thinking team. This pivotal role offers the opportunity to lead critical validation projects, ensuring compliance and excellence in equipment performance, sterilization, and process validation within a state-of-the-art facility. If you thrive in a collaborative setting and have a passion for technical precision, this could be your next career move.

What You’ll Bring:

• Strong background in engineering or scientific disciplines
• Extensive experience with Equipment Validation and Sterilization Validation
• Proven ability to develop and author validation master plans, protocols, SOPs, and final reports
• Excellent technical writing and oral communication skills
• Ability to analyze validation data and resolve technical issues efficiently
• Capable of working independently and within cross-functional teams to meet project objectives

Nice to Have:

• Previous experience supporting validation during sterile or cleanroom environments
• Knowledge of GMP standards and regulatory requirements
• Additional certifications in validation or quality assurance

Preferred Education & Experience:

• Degree in Engineering, Life Sciences, or a related field
• Demonstrated experience in validation activities, especially sterilization processes, within a regulated industry

Other Requirements:

• Valid work authorization within Ireland
• Willingness to support validation studies involving cleaning and sterilization processes

Take this opportunity to be a critical part of advancing innovative solutions in a thriving industry. If you possess the expertise and drive to excel in validation engineering, we invite you to apply now and contribute to shaping the future of quality assurance in healthcare manufacturing.
]]> Mon, 16 Feb 2026 00:00:00 EST 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.
]]> Mon, 16 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 The Opportunity
The primary responsibility of this position is to act as the labeling graphic designer on day to day activities and project teams under general direction from the reporting manager and/or designated senior member of the team, attend meetings, maintain project schedule and update the Supervisor.

Involved in the creation, review, revision and approval and publication of documentation and labeling for all site relevant products.

Assists in the coordination and maintenance of corporate standards as they pertain to documentation.

Who You Are
• 0-5 years of experience
• Strong problem-solving skills
• Excellent communication abilities
• Knowledge of industry best practices

Preferred (Optional)
Experience with Adobe Creative Suite preferred

Pay ranges between 25-28/hr based on experience ]]> Mon, 16 Feb 2026 00:00:00 EST 1 Join Our Team as a Clinical Site Coordinator – Drive Innovation in Clinical Research

Are you passionate about advancing medical science and making a tangible difference in patients' lives? We are seeking a dedicated Clinical Site Coordinator to play a vital role at our site in Astana, Kazakhstan. This full-time position offers a unique opportunity to work on groundbreaking clinical studies, supporting our mission to connect patients, physicians, and sponsors seamlessly and efficiently.

In this role, you will act as a key liaison between the medical site and sponsors or CROs, ensuring smooth study operations from patient enrollment to regulatory compliance. Your efforts will directly impact the success of clinical trials, helping to accelerate the development of revolutionary treatments that can change lives.

Required Skills:

• Minimum 2 years of experience as a Clinical Site Coordinator or in a similar role within clinical research
• Comprehensive understanding of ICH-GCP guidelines and clinical trial protocols
• Strong organizational skills with the ability to manage multiple tasks efficiently
• Excellent communication skills in both English and Kazakh
• Proven ability to work effectively under pressure and meet tight deadlines
• Attention to detail and accuracy in data entry and documentation
• Ability to handle regulatory documents and support study audits or inspections

Nice to Have Skills:

• Experience with electronic data capture (EDC) systems
• Familiarity with clinical trial contracts, budgets, and site payments
• Prior exposure to regulatory reporting, including adverse events and protocol deviations
• Flexibility to adjust working hours based on study needs

Preferred Education and Experience:

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or Laboratory Analytics
• At least 2 years of hands-on experience working at clinical research sites or in clinical trial coordination

Other Requirements:

• Willingness to work in a dynamic environment with fluctuating schedules
• Ability to travel locally for site visits or monitoring activities if needed
• Commitment to maintaining the highest standards of study conduct and compliance

Take this opportunity to contribute to cutting-edge clinical research that has the potential to transform healthcare. If you’re ready to join a forward-thinking organization dedicated to quality and innovation, apply now to become part of our dedicated team as a Clinical Site Coordinator.
]]> Sat, 14 Feb 2026 00:00:00 EST 1 Location: London (hybrid, 1–2 days per week on-site)



Are you an experienced healthcare insights professional ready for your next leadership step? This is an opportunity to join a fast?growing, boutique market research consultancy known for delivering high?impact strategic insights across the healthcare and life sciences space.
About the Company
This independent, full-service agency has developed a strong reputation for delivering rigorous and meaningful research across a broad range of healthcare topics. 

You’ll join a collaborative mixed?methods team that combines qualitative and quantitative expertise. It’s an environment that’s highly client?facing, supportive, and committed to delivering research that genuinely influences decision?making and improves patient experiences.
The Opportunity
As a Research Director, you will lead multi?market healthcare studies, overseeing the full project lifecycle from initial brief to final delivery. 

This role is ideal for someone who wants to:

• Work across a variety of methodologies
• Influence client strategy with well?crafted insights
• Lead and mentor project teams
• Enjoy autonomy, ownership, and a strong development pathway
• Contribute to an innovative and growing consultancy environment

Key Responsibilities

• Lead complex mixed?method healthcare studies from start to finish
• Build strong relationships with clients, shaping briefs and leading presentations
• Oversee the development of research materials (screeners, guides, surveys) with hands?on involvement
• Drive analysis and reporting, ensuring strategic, actionable insight
• Manage and mentor researchers, providing guidance, feedback, and support
• Ensure smooth project delivery, high quality outputs, and adherence to timelines
• Contribute to internal capability building and process improvements

About You
You will thrive in this role if you’re curious, proactive, and comfortable taking the lead across multiple workstreams.

Essential experience:

• 7+ years in healthcare market research
• Strong experience across both qualitative and quantitative methodologies
• Proven ability to run studies end?to?end
• Experience leading teams and mentoring junior researchers
• Demonstrated career stability and progression
• Experience across multiple therapy areas within healthcare

Desired:

• Moderation skills
• Experience designing guides, surveys, and strategic deliverables
• Strong storytelling and client advisory capabilities

  ]]> Fri, 13 Feb 2026 00:00:00 EST 1 *depending on experience

Main duties will include:

• Leading cross-functional teams in project management and execution for key initiatives across CSPV

• Supporting the Management Office and Business Excellence lead in implementing PMO structure within CSPV

• Collaborate with CSPV leadership to drive Business Excellence activities supporting the globalization of CSVP

Responsibilities include:

• Project management, including aligning with stakeholders, setting objectives, developing, and tracking project plan, timelines, and milestones, tracking deliverables, resolving key issues and achieving desired outcomes.

• Generating and reporting status reports to leadership

• Generating and tracking communication plans to key stakeholders

• Identifying risks, issues, and dependencies

• Facilitating global, cross-functional, collaborative discussions to drive outcomes


Skills:

• Need to have drive; take initiative; and be proactive 
• Strong communication, organizational, and management skills
• Minimum 7 years Project Management in Pharmacovigilance or Clinical Development experience in pharmaceutical industry required
• Ability to independently manage priorities by organizing workload efficiently
• Demonstrated ability to manage cross-functional teams to a desired outcome
• Knowledge of MS Suite (Excel, PowerPoint, Word, Visio, Project)
• PMP certification preferred but not required

Education: 

• Bachelor’s degree in science, management, or related degree.

Certifications: 
PMP certification

 ]]> Fri, 13 Feb 2026 00:00:00 EST 1
Summary:
This manufacturing engineering role will be responsible for planning and executing the move of commercial and NPD metals manufacturing lines into a new facility to align with future growth needs of the metals operation.

Job Responsibilities:
• Drive the line movement workstream of the metals facility move project as the technical project lead
• Develop and execute a process validation plan including IQ/OQ/PQ for manufacturing equipment as well as facilities utilities equipment
• Create robust shutdown & startup procedures to ensure minimal disruption to metals production & continued supply of critical components
• Liason with external suppliers for movement, calibration, and other activities as needed associated with the new facility
• Collaborate with internal cross-functional partners such as quality, project management, facilities, operations, supply chain, and other groups to ensure requirements are met & production delivery is maintained
• 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.

Skills:
• Equipment & Process Validation Experience
• Team player and detail oriented.
• Project management/project leadership experience
• Experience with highly complex/automated manufacturing equipment

Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 years experience required.]]> Fri, 13 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
Job Details: The role will support the inspection, sampling, and testing of raw materials that are received at the North Carolina (NC) site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.

Primary Responsibilities of the Role Include:

• Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met
• Remove samples from containers of medias and other chemicals to facilitate the testing of samples
• Use RAMAN technology with TruScan equipment to identify chemicals
• Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements
• Responsible for accurately documenting inspection, sample, and test results in systems
• Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures
• Ability to determine the color of components match required attributes
• Support inspection readiness activities
• Supports Continual Improvement initiatives, programs and projects
• Assist area management with the prioritization and scheduling of tasks
• Serve as a trainer in tasks associated with raw material inspections, samples, and testing
• Own controlled documents for the area including SOPs and FORMs
• Initiate and own deviation records and CAPAs associated with events and projects in ANCs raw material inspections, samples, and testing areas
• Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.]]> Thu, 12 Feb 2026 00:00:00 EST 1 *depending on experience

Summary:
PerkinElmer is seeking a visionary technical communicator who is passionate about clear communication and creating exceptional customer experiences. You’ll revolutionize how customers interact with our product information by integrating modern technology into every step of content creation. Your focus will be on developing intuitive, web-based help content that empowers users to effectively utilize our laboratory instrument systems. If you’re ready to shape the future of content excellence in a dynamic scientific and engineering environment, we encourage you to apply.
Responsibilities:
• Design and develop intuitive technical content for web-based, customer-facing help which enables customers to effectively use our portfolio of laboratory instrument systems, applying strong UI/UX design principles.
• Apply processes for modular, single-sourced content creation, leveraging MadCap Flare authoring environment.
• Design content based on user learning principles, ensuring information is easily accessible, intuitive, and highly effective for the target audience.
• Create new, high-quality technical content which targets multiple user personas, ensuring clarity, accuracy, and completeness.
• Ensure the help product adheres to established brand guidelines, style guides, and internal standards.
• Leverage user feedback for continuous improvement, leading analytical and iterative content development cycles.
• Collaborate with global cross-functional teams, ensuring effective communication and coordination directly in step with the product development lifecycle.
Basic Qualifications
• Bachelor’s degree required in Technical Communication or a science/engineering related discipline.
• Demonstrated proficiency in HTML and XML authoring, with a strong understanding of modular content and single-sourcing methodologies.
• Mid to expert level experience using MadCap Flare and the associated suite of products.
• Ability to integrate and optimize the use of AI within technical communication workflows.
• Strong UI/UX design principles with an emphasis on creating intuitive, engaging, and accessible user experiences.
• Familiarity with embedding multimedia into web-based help content.
• Experience implementing meta tags and structured content focused on providing key information to an AI chatbot.
• Demonstrated ability to work cross-functionally and collaboratively in a global, fast-paced environment.
• Exceptional time management and organization skills with proficiency managing and tracking projects using Jira.
• Highly detail oriented with excellent problem solving and communication skills.
• Native level fluency in written and spoken English.
 ]]> Thu, 12 Feb 2026 00:00:00 EST 1 Location: Fort Myers, FL
Permanent FTE
M-F: Day Shift

Position Summary:
This is a staff-level position within our client's medical team that will work supporting hospital-based clients. The role will provide expert diagnostic information focused on Breast & Pediatric specialties and will analyze clinical laboratory data to provide professional pathological opinions on Surgical Pathology cases. 

Responsibilities:

• Focus on diagnostic Surgical Pathology case sign out and service
• Perform frozen section evaluations, as needed
• Render expert gross and/or microscopic diagnoses, incorporating advanced molecular or genetic information when appropriate
• Perform delegated medical director duties with regards to both anatomic and clinical laboratories
• Share equally in hospital pathology on-call schedules and tumor board responsibilities
• Perform rare adult post-mortem examinations
• Read and interpret clinical laboratory data and provide professional consultation on clinical pathology inquiries
• Perform quality control and quality assurance procedures and participate in departmental professional quality control and quality assurance activities
• Assist the laboratory administrative director and Pathology Chair in delegated supervision of technical and support staff
• Work closely with clinical and administrative staff at the NeoGenomics Hospital Client as well as NeoGenomics leadership to ensure the highest standards of turnaround time, quality, and customer service are maintained
• Provide expertise and assistance to technologists and technicians to resolve case issues

Experience, Education and Qualifications:

• M.D. or D.O degree and board certification in Anatomic and Clinical Pathology required,
• Three years of post-residency experience preferred but not required
• Breast and/or Pediatric, Oncologic Pathology, Gynecologic Pathology, Genitourinary Pathology, or Head and Neck pathology fellowship strongly preferred
•  Must hold valid unrestricted license to practice medicine in FL or be eligible to obtain licensure
• Strong customer focus and understanding of hospital/laboratory operations
• Ability to fulfill CLIA ’88 if required.

]]> Wed, 11 Feb 2026 00:00:00 EST 1 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.
]]> Tue, 10 Feb 2026 00:00:00 EST 1 The Opportunity:  ESR Contract Manager

Revolution Medicines is seeking a highly motivated and detail-oriented individual to manage all aspects of Expanded Sponsored Research (ESR) contracts, including Investigator-Sponsored Trial (IST) agreements. The ESR Contract Manager plays a pivotal role in negotiating contracts and budgets aligned with protocol specifications, ensuring compliance with company regulatory, and fair market value (FMV) standards. The contract manager will be responsible for maintaining tracking systems and overseeing investigator contracts and budgets. Additionally responsible for timely and accurate processing and administration of payments to the sites. This role is an individual contributor with team leadership responsibilities, reporting to the Director, Clinical Site Contracts.

Required Skills, Experience and Education:

• 
  BS/BA degree in related discipline and a minimum of seven years of related experience; or,
  
• 
  Develop clinical trial budgets according to protocol specifications.
  
• 
  Independently manage clinical trial contract/budget negotiations with sites.
  
• 
  Maintain a tracking system of all ESR(IST) agreements, issues, and communications with internal and external sources regarding contract and budget status.
  
• 
  Review and negotiate investigator-prepared budgets for FMV compliance.
  
• 
  Develop management reports to support budgeting and forecasting.
  
• 
  Maintain internal contact with relevant departments such as Drug Safety, Clinical Operations, Legal, Medical Affairs Operations, and others as necessary.
  
• 
  Help foster good relationships with clinical investigators.
  
• 
  Responsible for reconciliations.
  
• 
  Participate in team meetings.
  
• 
  Ensure compliance with policies and procedures.
  
• 
  Contract amendments, and is responsible for the developing work instructions, internal and external training, managing workload and preparing and monitoring tracking systems.
  

Preferred Skills:

• 
  Strong Excel knowledge required; GrantPlan experience.
  
• 
  Apply strong analytical and business communication skills.
  
• 
  Ability to work effectively in a team/matrix environment.
  
• 
  Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
  
• 
  Oncology experience.
  
• 
  Biotech/pharma experience a plus.
  
• 
  CMS experience.
  
• 
  Smartsheet experience.
  
• 
  Strong organization skills with knowledge in creating/managing spreadsheets. #
  

]]> Tue, 10 Feb 2026 00:00:00 EST 0 POSITION SUMMARY:
The Coordinator 2, Quality Systems plays a key role in maintaining compliance and supporting the integrity of the company’s Quality Systems.
This position is responsible for ensuring GxP records are properly managed and accessible, while contributing to the effectiveness of core quality processes, specifically managing quality event processes and supporting complaint handling.
The role requires strong attention to detail, organizational skills, and the ability to collaborate across teams to uphold regulatory standards and company procedures.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Responsibilities may include, but are not limited to:
Administer and monitor quality event processes, ensuring conformance to standards, and track operational performance.
Sort and categorize records in alignment with retention schedules, regulatory requirements, and company procedures.
Organize and maintain physical and electronic records to ensure accessibility, accuracy, and traceability.
Support complaint handling processes by accurately entering product complaint data into the system.
Assist with the maintenance and issuance of controlled logbooks.
Provide support across Quality System areas, including audits, CAPAs, document control, and training activities.
Perform additional duties as assigned to meet departmental and organizational objectives.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
High School Diploma (or equivalent) with 4+ years of experience in life sciences or medical device industry.
Strong foundation in records management and regulatory compliance.
Familiarity with MasterControl or similar Quality Management Systems.
Broad experience in Quality functions, including customer complaint processes.
Knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations and standards.
Demonstrates integrity, self-confidence, and commitment to prioritizing customer and patient safety.
Excellent interpersonal skills; able to collaborate effectively across all organizational levels.
Strong work ethic with a proactive approach—eager to learn, take on new responsibilities, and seek additional tasks when available.

ENVIRONMENTAL CONDITIONS:
Physical Activities:
On a continuous basis, remain seated at a desk for extended periods of time; intermittently answer the telephone and type on a computer.
The role may also require periods of standing and walking, as well as lifting and carrying objects weighing up to 20–30 lbs.
The noise level in the work environment is usually low to moderate.
The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job.

TRAVEL:
No travel is required for this role.



Pay Rate Range: $25-28/hr depending on experience ]]> Tue, 10 Feb 2026 00:00:00 EST 1 Join Our Team as a Statistical Scientist Lead – Drive Innovation in Pharma and Clinical Research

Are you a passionate and experienced statistician ready to lead cutting-edge clinical and biomarker studies? We are seeking a dynamic Statistical Scientist Lead to join an innovative organization committed to advancing health solutions. In this pivotal role, you'll leverage your expertise to support early-phase drug development, oversee complex analyses, and collaborate with global teams—all while making a meaningful impact on patient care.

What You Will Bring:

• Extensive experience in applying statistical methods within biomedical research, pharma, CRO, or academic settings.
• Deep knowledge of pharmacokinetics (PK) and proficiency in statistical programming languages such as SAS (required) and R (preferred).
• Proven ability to independently lead study design, analysis, and interpretation of complex clinical and biomarker data.
• Strong understanding of regulatory and industry standards for clinical data analysis.
• Excellent communication skills to coordinate seamlessly across multidisciplinary teams and with external stakeholders.

Additional Skills That Will Set You Apart:

• Experience in early-phase studies (Phase I) and familiarity with PK/PD strategies.
• Knowledge of advanced statistical techniques, AI/ML applications, and programming in R.
• Prior involvement in regulatory submissions, publications, or global study oversight.
• Biomarker analysis experience is a plus, but not essential.

Preferred Educational & Professional Background:

• PhD or MSc in Biostatistics, Statistics, or a related scientific discipline.
• Significant industry experience, typically 6+ years with a PhD or 9+ years with an MSc, demonstrating leadership and technical expertise.
• Background working within pharmaceutical companies, CROs, or environments heavily integrated with sponsors.

Other Requirements:

• Ability to work independently in a fast-paced, multi-tasking environment.
• Willingness to participate in a hybrid working model, with occasional in-office presence.
• Prior experience with early-phase, oncology, cell and gene therapy studies is advantageous.

If you are eager to lead innovative statistical initiatives within a patient-centric organization and thrive in a collaborative environment, we invite you to take the next step in your career. Apply now and become a vital contributor to transformative healthcare solutions.
]]> Tue, 10 Feb 2026 00:00:00 EST 1
You will work at the interface of biology and technology and will support the effort on assessment and development of custom NGS needs, to assist drug target and biomarker discovery efforts.

Responsibilities
• Extraction and preparation of DNA and RNA from various sources
• Preparation of DNA, RNA, and ATAC-seq libraries from bulk and/or single cells for NGS sequencing
• Perform quality control on samples and libraries.
• Troubleshoot the experimental procedures and protocols for library preparation and sequencing under supervision
• Perform Next Generation Sequencing experiments on Illumina platforms and other platforms
• Perform qPCR for library quality control
• Maintain updated working knowledge of Genomics technologies and develop significant experience in next-generation sequencing applications
• Keep records of experiments in electronic notebook (ELN)
• Deliver scientific findings effectively in group meetings and collaborative forums

Basic Qualifications
Masters Degree
OR
Bachelors Degree and 2+ years of scientific experience
OR
AA Degree and 4+ years of scientific experience
OR
High School Degree and 5+ years of scientific experience

Preferred Qualifications
• Bachelor's degree in Biological Sciences, Molecular Biology, Biochemistry, Bioengineering, Genetics, or related fields
• 2+ years of hands-on experience with Next Generation Sequencing (NGS) platforms, various NGS assays, and their underlying sequencing methodology
• Hands-on experience with DNA and RNA extraction from various sources
• Ability to learn new techniques in a fast-paced environment
• Demonstrated ability to solve scientific and engineering problems
• Excellent organizational skills and efficiency at getting tasks done
• Goal oriented and looking to take on additional responsibilities
• Experience working in a multi-disciplinary environment
• Experience working with LIMS and electronic notebook e.g. Benchling
• Excellent interpersonal, verbal, and written communication skills
• An excellent work ethic, ability to work in a dynamic environment, and ability to adapt to changing priorities

Pay ranges betwen 48-51/hr based on experience ]]> 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 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 Duties:
The Quality Assurance team is seeking a highly motivated and detail-oriented Quality Assurance Senior Associate to join our team at the Manufacturing Facility, LyFE in Bothell WA.
This individual will perform routine Quality Assurance tasks including but not limited to batch record review, raw material disposition, deviation investigation, CAPA, and change control approval, and other Quality Operations functions.
This role requires working either a Wednesday through Saturday shift or a Sunday through Wednesday shift, 10 hours per day, and is an onsite role with no remote work option.

• Review and approve executed electronic batch record comments and resolve discrepancies with manufacturing personnel.
• Review and approve executed test results, perform review tasks in the laboratory information management system to issue Certificates of Analysis (COAs) as applicable.
• Provide quality support for manufacturing operations in the cleanroom.
• Be a quality point of contact for process support escalations, troubleshooting, triage and resolution.
• Perform routine hands-on QA activities such as intake of incoming patient apheresis and drug product pack-out activities.
• Compile, review and approve lot disposition records.
• Perform routine raw material disposition and approve raw material specifications.
• Perform review and approval of Deviation, Change Control, CAPA, Excursion and Nonconformance record deliverables (as applicable).
• Promote a culture of safety and GMP compliance.
• Identify opportunities for continuous improvement.
• Provide support to complex change controls (as applicable).
• Support Process and/or Method Qualification and Validation activities by providing quality review of associated protocols, data and reports.
• Perform internal audits (as applicable).
• Support operational excellence initiatives.

Skills:

• Experience in clinical and cGMP manufacturing required.
• Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
• Ability to work effectively both independently and with a team to set goals, develop sound project plans, monitor progress, and report results.
• Excellent communication, emotional intelligence and interpersonal skills.
• Motivated and organized critical thinker with solid cross-collaboration and business communication skills.
• Fast learner, adaptable, with creative problem-solving skills.
• Ability to work efficiently, prioritize workflow, meet deadlines and balance competing.
• The desire and ability to work in a fast-paced, start-up environment.
• Excellent analytical skills and scientific/technical expertise.

Education:

• BS degree with 7+ years experience in a relevant field (e.g. biochemistry, chemical engineering, bioengineering, or related scientific field).
• 4-6+ years of experience in GMP biopharmaceutical operations with a minimum of 2+ years in GMP quality.
• Proficiency using multiple digital GMP platforms.
• Familiarity with Cellular Therapy manufacturing.
• Familiarity with Lentiviral Vector manufacturing.

Pay Rate Range: $35-48/hr depending on experience ]]> Mon, 09 Feb 2026 00:00:00 EST 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

  ]]> Fri, 06 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
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.
]]> Fri, 06 Feb 2026 00:00:00 EST 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]]> Fri, 06 Feb 2026 00:00:00 EST 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

]]> 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 A rapidly expanding med?tech organisation is preparing to launch its Orthopaedic reconstruction portfolio across ANZ and is seeking an experienced leader to establish and grow the business in Australia. With no existing Orthopaedics team locally, this role represents a rare chance to build a function from the ground up and shape national strategy from day one.

The position is headquartered in Sydney, where the company’s Australian office is located.

---

About the Opportunity
This is a senior, field?based commercial leadership role focused on Hip & Knee implant reconstruction. You will be responsible for territory activity, distributor strategy, national sales performance, and early?stage business development, while also taking on line management responsibilities as the team grows.

This role is best suited to someone with deep experience in orthopaedics who is ready to lead the launch of a new product division in Australia.

---

Key Areas of Responsibility 1. National Sales Leadership

• Own commercial performance for Hip & Knee reconstruction across Australia
• Lead and mentor future team members as the business scales
• Manage relationships with surgeons, hospital decision?makers, OR personnel, and procurement groups
• Deliver revenue growth, market share expansion and territory development in line with the business plan
• Oversee case support, educational activities, workshops and theatre?based engagement

---

2. Business Management

• Build and maintain strong relationships with hospital finance and administration for efficient payment cycles
• Work with national leadership on pricing strategy and market positioning
• Establish distribution agreements that align with volume expectations and commercial objectives
• Understand reimbursement structures, purchasing pathways and insurance processes across the region
• Ensure timely execution of commercial, marketing and clinical activities

---

3. Channel & Distribution Strategy

• Identify, onboard and develop distributors, sub?distributors and independent agents
• Provide training, communication and planning support to ensure smooth operations
• Oversee inventory coordination and product availability across the network
• Collaborate with regional leadership to optimise supply chain needs

---

4. Business Development

• Drive adoption of Hip & Knee reconstruction solutions in both new and existing hospitals
• Conduct meetings with surgeons, committees, buying groups and decision?makers to introduce technology and support evaluations
• Present clinical evidence, demonstrations and product information to support purchasing decisions
• Build long?term partnerships with key accounts nationwide

---

5. Market Research & Strategy

• Conduct detailed mapping of hospitals, surgeon profiles, implant usage and pricing trends
• Track competitor activity, procedure volumes and reimbursement dynamics
• Maintain structured intelligence on operator preferences, product evaluations, and hospital affiliations
• Monitor upcoming tenders, procurement changes and national market shifts
• Feed insights into business planning and strategic decision?making

---

6. Compliance & Professional Standards

• Ensure all activities comply with local regulations, organisational policies and ethical standards
• Maintain transparent and responsible engagement with surgeons and hospital stakeholders
• Provide required information and updates to hospital partners as needed

---

Who You Are

• 10+ years of Orthopaedic sales experience specifically in Hip & Knee implants
• Recent experience within the last year in reconstruction/theatre settings
• Proven people?management experience within orthopaedic sales
• Strong commercial instincts with the ability to build a business from zero
• Skilled in distributor management, hospital engagement and national account development
• Driven, adaptable and comfortable working in a launch environment

]]> Thu, 05 Feb 2026 00:00:00 EST 1 The Opportunity:  Senior Manager, Commercial Regulatory Affairs

Seeking a Senior Manager, Commercial Regulatory Affairs to partner closely with the cross-functional teams to ensure that all promotional and medical communication strategies are compliant with applicable regulations, industry standards, and internal policies. This role will help enable successful product commercialization while upholding regulatory integrity and scientific accuracy.

As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

• 
  Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.
  
• 
  Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.
  
• 
  Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.
  
• 
  Train and advise cross-functional teams on commercial regulatory compliance, MLR process and best practices.
  
• 
  Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings.
  
• 
  Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.
  
• 
  Participate in the development and maintenance of MLR operational objectives, policies, and procedures.
  

Required Skills, Experience and Education:

• 
  Bachelor's Degree in a relevant field with 5+ years relevant experience.
  
• 
  8+ years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.
  
• 
  Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews.
  
• 
  Strong, current understanding of scientific exchange and pre-approval discussions; ability to unpack and deploy these concepts in practice.
  
• 
  Track record of influencing cross-functional decisions and operating with sound regulatory judgment.
  
• 
  Excellent communication skills and ability to work collaboratively across teams.
  
• 
  Collaborative and solution-oriented mindset and approach.
  
• 
  Exemplary compliance ethics and high concern for standards.
  
• 
  Advanced degree in a relevant field.
  
• 
  Experience in oncology therapeutic areas.
  
• 
  Experience with product launches.
  

]]> Thu, 05 Feb 2026 00:00:00 EST 0
This position supports Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.

Primarily responsible for ensuring adherence to equipment and computer validation standards and procedures. Responsibilities include participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports. Provides guidance and sets standards in producing quality documentation and serves as an advisor to Engineering, IS and Manufacturing functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT compliance issues. Executes quality oversight directly in Quality systems.

Qualifications: Bachelors degree in engineering, Biochemistry, Biology, Chemistry, or related science field. Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices. Experience managing projects through completion while meeting timelines. Evaluating documentation and operations according to company procedures and related regulations. 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. Solid understanding and application of aseptic behaviors and principles]]> Thu, 05 Feb 2026 00:00:00 EST 1 Pay 50-60/h depending on experience

Top 3 technical  skills that are required for the role:

1. Leads successful validations of packaging systems for medical devices
2. Able to conduct Packaging systems Gap Analysis according to ISO11607 Part 1 and 2
3. Lead project meetings and provide updates to management

Education Required: Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline

Years’ Experience Required: Minimum of 5 years in medical device or pharmaceutical industry in Packaging

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hybrid, onsite 4 days per week (North Haven CT or Lafayette CO) Please list which location at the top of the resume when submitting candidates

What is your timeline for scheduling interviews? ASAP

What product line will this person support? Various within Surgical OU


The packaging engineer is part of a dynamic team that provides expertise in packaging engineering and ensures quality and regulatory compliance. Supports and/or leads projects and collaborates with stakeholders to achieve desired results. Responsibilities include the following:

 

• Evaluate the current state of various medical device product packaging design; perform gap analysis on existing studies to the latest industry standards such as ISO11607 Part 1 and 2.
• Generate and execute packaging remediation plans for sterile barrier systems and non-sterile medical device packaging. Define remediation plans, generate/execute protocols, author closing reports, update specifications and technical documentation.
• Leads successful validation of packaging systems for medical devices
• Identify and develop innovative packaging processes and designs as part of a cross functional team. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of device protection required.
• Utilize quality and regulatory compliance knowledge to support regulatory body audits, draft technical responses and provide innovative ideas to ensure compliance to latest industry practices.
• Lead project meetings and provide updates to management.
• Assist in labeling development process.
• May perform and evaluate testing in a laboratory environment as per industry standards.

 

 

Minimum Requirements

 

• Bachelor of Science Degree in Packaging Science, Mechanical Engineering or similar discipline.
• Minimum of 5 years in medical device or pharmaceutical industry in Packaging or Quality Engineering.
• Requires practical knowledge and demonstrated competence within packaging engineering typically obtained through advanced education combined with experience.
• Knowledge and general understanding of ISO 11607 part 1 and 2, ASTM and ISTA package test methods is required.
• Established and productive individual contributor with strong team and interpersonal skills.
• Knowledge of Microsoft Office programs is required.
• CAD/CAPE/TOPS Software knowledge is preferred.

]]> Wed, 04 Feb 2026 00:00:00 EST 1 Additional position details from the manager:
 

1. What products (if any) will this role support? Implantable Pacemaker and Implantable Cardioverter defibrillator testing
2. What is your target years of experience? Recommend 3 years of experience

_______________________________________________________________________________________________

This Test Engineer position is responsible for providing key technical expertise and organizational leadership and focus for developing the test capability necessary to evaluate products to meet standards compliance, regulatory approval, and business’s needs.  This position provide support that spans the full range of research, technology, and development of new and derivative products.

The Test Engineer will work with designers and reliability engineers and technicians to develop and execute strategies that provide the test capabilities necessary to drive decisions and support regulatory submission

Cardiac Rhythm Management (CRM) delivers innovative therapies and solutions for cardiac diseases, pain, and spasticity.
CRM delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.

Responsibilities/ A Day in the Life

• Plan and provide test capabilities early in project development, and drive the identification and proper collection of test objectives, requirements, measures, and metrics. 
• Understand applicable product/system test requirements and provide inputs.
• Develop, validate, implement test methods and systems to meet design and reliability requirement by collaborating with Design, Reliability, Operations, Regulatory Affairs, and other cross-functional partners. Must be established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments

• Lead and execute Installation Qualifications (IQ)
• Perform re-validation on legacy methods and system
• Contribute to the completion of group objectives, through building relationships and consensus to reach agreements on assignments.
• Problem solver. Problem and issues faced in this position are general, and may require understanding of broader set of issues or other job areas but typically are not complex.
• Make improvements to processes, systems to enhance better performance.
• Provide guidance, coaching and training to other lower engineers and Technicians
• Manage projects, delegation of work and review of reports from others.
• Lead and participate both mechanical and electrical test development.
• Communicate clearly the project plans and deliverables to management and project teams where applicable.
• Support ISO-17025 lab accreditation.

Must Have: Minimum Requirements (Must be evident on your resume)

• Bachelor’s in Mechanical or Electrical engineering, science or related technical field with 2+ years in Engineering

Nice to Have:  Preferred Requirements

• 2+ years of test engineering experience.
• Knowledge of Verification and Validation (V&V) practices and techniques.
• Problem solving skills, including demonstrated application of structured problem solving methods and tools

• Familiar with statistical analysis tools such as Minitab or JMP

• Experience with testing in both a manual and automated environment
• Familiar with ISO-17025 lab accreditation
• Proficient with MS Word
• Proficient with MS Excel

]]> Tue, 03 Feb 2026 00:00:00 EST 1

Culturing mammalian cells in shake flask and benchtop bioreactors.

Support lab operational activities for rAAV cell culture studies in stirred tank bioreactors including AMBR15 and/or AMBR250 bioreactors.

Execution of molecular biology experiments including SDS-PAGE/western blotting, plasmid cloning etc.

Execute experimental designs; collect and format data for analyses in support of technical platform development objectives.

Compile data analysis summaries and present to appropriate project teams

Contribute to the authoring of lab procedures, data analysis summaries, and support data verification and other relevant process documentation.

Maintaining an accurate laboratory notebook following ALCOA+ principles.

Ensuring work conforms to applicable quality and safety standards.

Support maintenance and troubleshooting of laboratory equipment.

Other duties as assigned including but not limited to contributing to lab organization and cleanliness, consumables stocking, and routine equipment maintenance.
Education and Experience:

• B.S. in chemical engineering, chemistry, biochemistry, or biology/molecular biology or related area with 0 - 4 years of relevant scientific or technical experience in the life sciences industry or equivalent.
• Comfortable working with instrumentation and technologies in support of cell culture process monitoring. Digital data proficiency a plus.
• Experience with aseptic suspension cell culture methods, including sterile media and solution preparation is preferred.
• Experience in molecular biology techniques (eg:SDS-PAGE/western blotting, plasmid cloning, gene expression assays, etc) is preferred.
• Experience with viral vector production is preferred, but not essential.
• Organizational, record keeping, and communication skills.

Pay Rate Range: $30-$41/hr depending on experience  ]]> Tue, 03 Feb 2026 00:00:00 EST 1
Communication and Liaison:
Serve as the primary point of contact between the client and the GCs superintendent, ensuring seamless communication and coordination for all construction-related matters.
Foster collaborative communication, facilitating effective coordination and information exchange between the client teams and construction field personnel.
Construction Oversight and Management:
Supervise all construction activities to ensure alignment with project objectives, specifications, and regulatory standards.
Manage the construction schedule, monitoring progress towards milestones and critical paths to ensure timely project completion.
Address and resolve construction issues or conflicts in collaboration with the GCs superintendent, applying solutions to maintain project momentum and quality.
Compile and disseminate regular construction reports and updates to project stakeholders, highlighting construction initiatives, accomplishments, risks, and opportunities for further improvement.

Safety and Compliance Enforcement:
Enforce adherence to EHS standards and cGMP regulations throughout the construction phase.
Conduct regular site inspections and safety audits (GEMBA) with the safety team to identify and mitigate potential hazards, promoting a safe working environment.

Quality Control:
Implement quality control measures to maintain construction standards and specifications, conducting regular inspections and quality assurance checks.

Team Leadership:
Lead the construction team, providing guidance and promoting a collaborative and productive work environment conducive to achieving project success.

Risk Management and Scheduling:
Lead Risk Assessments at project milestones to identify potential risks and formulate mitigation strategies.
Lead Constructability Design Reviews to ensure the project's design is feasible and practical for construction implementation.
Define and communicate responsibilities for project deliverables, establishing approval limits and escalation procedures.
Provide expertise in identifying project-specific risks, supporting risk assessment and evaluation of their cost and schedule impacts.
Participate in periodic risk reviews and act as risk owner for designated risks.
Be consulted on the Overall Master Schedule, including baseline updates and reporting, ensuring the project's schedule is comprehensive and realistic.
Consulted on Schedule Development/Updates, ensuring that project scheduling is effective and supports the execution approach.
Accountable for the verification of contractor schedules, ensuring they accurately reflect planned construction activities and timelines.
Ensure the achievement of construction milestones, monitoring progress and coordinating necessary adjustments to maintain project timelines.

pay ranges between $75-85/hr based one xperience ]]> Tue, 03 Feb 2026 00:00:00 EST 1 Mon, 02 Feb 2026 00:00:00 EST 1
Seeking a highly motivated Senior Research Associate to join our Cell Culture Team and support early discovery programs. This is a hands-on laboratory role focused on generating high-quality cellular materials to enable critical go/no-go decisions. The ideal candidate is detail-oriented, collaborative, and thrives in a fast-paced discovery environment.

As the team and function grow, this role can offer meaningful opportunities for professional development and expanded responsibilities.

What you will do:

• 
  Perform routine mammalian cell culture, including expansion, maintenance, cryopreservation, and thawing of multiple cell lines.
  
• 
  Maintain accurate cell line inventory and experimental documentation using Benchling.
  
• 
  Respond to urgent, time-sensitive requests from discovery teams to support key program milestones.
  
• 
  Develop protocols and document experimental workflows and observations with high rigor.
  
• 
  Partner closely with cross-functional teams to assess cell line needs and deliver materials on defined timelines.
  
• 
  Contribute to a culture of transparent, proactive communication across teams.
  
• 
  Identify opportunities to improve efficiency, robustness, and scalability of cell culture workflows.
  

Required Skills, Experience and Education:

• 
  B.S./M.S. degree in Molecular Biology, Cell Biology, Cancer Biology, or related life science field with 3+ years of hands-on mammalian cell culture experience; biopharmaceutical or biotechnology industry experience preferred.
  
• 
  Demonstrated expertise in aseptic technique and mammalian cell culture, including:
  
  • 
    Concurrent handling of multiple cell lines
    
  • 
    Media preparation with complex supplements
    
  • 
    DMSO dilution calculations and cryopreservation best practices
    
• 
  Strong experience optimizing and troubleshooting mammalian cell culture systems.
  
• 
  Familiarity with cell culture quality control practices (e.g., mycoplasma testing, cell line authentication).
  
• 
  Proficiency with electronic lab notebooks (e.g., Benchling) for experiment documentation, inventory management, and workflow execution.
  
• 
  Excellent organizational skills with meticulous attention to detail and data integrity.
  
• 
  Strong written and verbal communication skills
  
• 
  Ability to work independently while collaborating effectively across teams.
  
• 
  Ability to prioritize work, meet deadlines, and remain composed in a dynamic, fast-paced environment.
  
• 
  Familiarity with standard laboratory equipment (microscopes, pipettes, centrifuges, cell counters).
  
• 
  A positive, flexible, and collaborative mindset with a continuous improvement mentality.
  

Preferred Skills:

• 
  Experience working with cancer cell lines, primary cells, or genetically engineered cell lines.
  
• 
  Experience with viral and non-viral transduction or transfection methods (e.g., lentivirus, retrovirus, lipid-based systems).
  
• 
  Hands-on experience with 2D and 3D cell culture systems, including spheroids and/or organoid models.
  
• 
  Exposure to cell-based assay development and downstream applications (e.g., viability, proliferation, reporter assays).
  
• 
  Experience supporting early discovery or translational research programs.
  
• 
  Experience in regulated or semi-regulated laboratory environments with strong documentation standards.
  
• 
  Exposure to automation, high-throughput cell culture, or scale-up workflows.
  

]]> Mon, 02 Feb 2026 00:00:00 EST 0 --

Position Summary:
 
The Cytotechnologist will be responsible for screening non-gynecologic cytology specimens and providing Rapid On-Site Evaluations (ROSE) for a wide range of procedures, including robotic-assisted bronchial biopsies. This position supports pathologists and clinical teams by ensuring specimen adequacy and contributing to timely, high-quality patient care.
 
Responsibilities:

• Receives cytology specimens and ensures proper specimen ID, accessioning and labeling of all tissue samples
• Processes paperwork associated with accessioning and reporting
• Performs routine and non-routine activities involved in the preparation of slides for cytology evaluation by pathologist(s), according to established SOPs
• Submits slides with abnormal cell structures to pathologists for further examination
• Examines cell samples to detect abnormalities in the color, shape, or size of cellular components and patterns
• Provides patient clinical data or microscopic findings to assist pathologists in the preparation of pathology reports
• Maintains effective laboratory operations by adhering to standards of specimen collection, preparation, or laboratory safety
• Examines specimens using microscopes to evaluate specimen quality
• Helps maintain acceptable productivity, TAT and workflow
• Reports problems concerning individual cases, tests, equipment, and supplies to the department supervisor or lead technologist to ensure timely resolution

Experience & Required Qualifications:

• Associate’s degree in the field and complete a one-year internship or complete a long-term training program in a cytology lab
• Three years or equivalent experience as a Cytotechnologist preferred
• ASCP license in Cytology and current Florida Histotechnician or Histotechnologist license required
• Basic understanding of laboratory techniques
• Possesses appropriate computer skills to accomplish tasks
• Ability to communicate effectively
• Strong organizational skills and attention to detail
• Ability to work independently
• Must be able to work in a fast paced, multi-tasking environment and maintain production and quality standards

]]> Mon, 02 Feb 2026 00:00:00 EST 1

Can you please confirm your top 3 skills sets required?  Reliability Engineering, Test Method Development, Test Method Validation

Can you please confirm the 3 main responsibilities/day to day activities required for this role?  Setup and execution of test methods for Test Method Validation or Design Verification, Report writing and approval, Custom sample and/or fixture development.

What products (if any) will this role support?  CAS products (e.g., Affera, Pulse Select, AFA Pro, etc.)

What is your target years of experience?  1-3 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?  ASAP

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

Responsibilities may include the following and other duties may be assigned. Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs. Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability. 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 engineering programs to achieve company, customer and governmental agency reliability objectives. May develop mathematical models to identify units, batches or processes posing excessive failure risks. As necessary, proposes changes in design or formulation to improve system and/or process reliability. May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.

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
]]> Mon, 02 Feb 2026 00:00:00 EST 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%
  

]]> Sun, 01 Feb 2026 00:00:00 EST 1 Area Sales Manager – Johannesburg / South Africa
(Structural Heart / TAVI Portfolio)

We’re partnering with a leading medical technology organisation to support their search for an experienced Area Sales Manager to drive regional growth across Johannesburg. This role focuses on a well?established TAVI (Transcatheter Aortic Valve Implantation) portfolio, working closely with clinical and commercial teams to expand market presence and deliver best?in?class support to cardiac centres.
Role Overview
As the Area Sales Manager, you will take ownership of commercial performance across the region, ensuring strong adoption and utilisation of TAVI solutions. You will support hospitals, surgeons, and cath lab teams while leading a high?performing sales force dedicated to structural heart therapies.
Key Responsibilities

• Lead and develop the regional sales team to achieve growth targets for the TAVI portfolio
• Build and maintain strong relationships with cardiologists, cardiac surgeons, and hospital stakeholders
• Support case coverage, training, and education in clinical environments
• Identify new opportunities to expand market share and strengthen product adoption
• Collaborate with cross?functional teams to align on strategy, forecasting, and territory planning
• Provide insights on competitor activity, customer needs, and market evolution

About You

• Strong background in cardiovascular, cath lab, or structural heart technologies
• Proven experience in territory, regional, or area sales leadership
• Confident working in clinical settings and partnering with medical professionals
• Commercially astute, strategically minded, and highly collaborative
• Passionate about bringing impactful therapies to patients and supporting clinicians

]]> Fri, 30 Jan 2026 00:00:00 EST 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
  

]]> Thu, 29 Jan 2026 00:00:00 EST 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.
]]> Thu, 29 Jan 2026 00:00:00 EST 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)
  

]]> Thu, 29 Jan 2026 00:00:00 EST 1 Target Pay Rate: 35.71-39.29/hr **salary will be commensurate with experience 

Job Description:
• Draft, review, and manage assigned contracts within contract management system.
• Identify legal, financial, risk management, tax, and other contract terms for review by subject matter experts.
• Assist attorneys in contract negotiations.
• Partner with and educate internal stakeholders on contract related issues.
• Possess the ability to work in a fast-paced environment, while constantly adapting to meet competing priorities.
• Collaborate with other Commercial Legal Services team members.
• Perform specified duties in a professional manner and in accordance with Alcon values and behaviors.
• Perform other duties, as assigned.

WHAT YOU'LL BRING TO ALCON:
• High School Diploma or equivalent
• Paralegal Certificate
• The ability to fluently read, write, understand and communicate in English
• Contract review experience

PREFERRED QUALIFICATIONS:
• Five years prior paralegal experience and Paralegal Certificate or Bachelor’s degree
Prior experience with contract drafting and management
 
]]> Mon, 26 Jan 2026 00:00:00 EST 1 In this exciting role as a Senior Quality Engineer you will have responsibility for the Quality and Compliance of process
development and manufacturing of implantable Cardiac and Neuromodulation medical device related products at the company's Tempe Campus.
 

1. What is the business title? Sr. Quality Engineer
2. Where is the work to be performed? (Please list preferred UHG facility, if other please specify i.e. remote work, rural, etc.) If hybrid, what is the onsite structure? On-site in Tempe, Arizona at the  Tempe Campus (MTC)
3. Can you please provide a summary of the project/initiative which describes what’s being done?  As a Senior Quality Engineer you will have responsibility for the Quality and Compliance of process development and manufacturing of implantable Cardiac and Neuromodulation medical device related products at the company's Tempe Campus.  Initial scope of work may be focused on Inspection Optimization projects in addition to other duties supporting Quality in manufacturing operations of microelectronics assembly and IC and Wafer assembly.
4. What does the team make-up look like – how many members and what is the break-down of the team’s skill sets (ex: 1 PM, 4 Developers, etc.)?  Current team includes 5 Operations Quality Engineers and 2 Quality Technicians with varying levels of experience and skillset in the medical device field.
5. What are the top 5 responsibilities for this position? (Please be detailed as to what the candidate is expected to do or complete on a daily basis)

• Leading and managing Inspection Optimization projects that span different processes in our microelectronics assembly line.  Including both manual visual inspection and automated/semi-automated inspection methods.
• Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, & OQPQ ensuring compliance and rigor.
• Partnering with process engineers on development of Test Methods and Test Method Validation plans and execution.  Spans both attribute and variables TMVs (Gage R&Rs/MSAs).
• Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.

What skills/attributes are a must have (Please be detailed as to number of years of experience)?

• Requires a Baccalaureate Engineering degree and minimum of 4 years of relevant experience OR Master's Engineering degree with a minimum of 2 years relevant experience
• Experience with general quality principles, procedures and methodologies
• Proficiency in Microsoft Office Applications (Word, Excel, Powerpoint, Teams)
• Strong background in Equipment Development, IQ, Process Characterization,OQPQ, and Test Method Development and Validation.
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.)

What skills/attributes are nice to have?

• 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience.
• DRM or DFSS certification
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• Six Sigma or Lean Sigma belt certification
• Strong statistical analysis techniques & DOE design and execution
• Strong understanding of medical device manufacturing processes and products

A Day in the Life
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. 
• Ensure internal quality processes, procedures and systems are compliant to all governing standards.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Work with the customer and local Design teams to ensure appropriate Design Outputs have been provided to the
manufacturing team that enable high product quality via Process and Test Method Validations.
• Support manufacturing development and continuous improvement as the Quality team member for process development and validation including Equipment Development, IQ, Process Characterization, OQPQ and Test Method Development and Validation.
• 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.
• Use knowledge of statistics on acceptance criteria, DOE and comparison testing to support manufacturing engineers in the development of compliant test plans andreports.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Support risk assessment processes for manufacturing and development including process FMEA and design FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
• Develop and support solutions for monitoring and reporting as well as taking appropriate action based on quality metrics; which includes performance scorecards, issue reporting and other performance measures.
• Support CAPA investigations, improvements, and effectiveness verification testing
• Lead and/or support investigations of non-conforming product, materials, or processes through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer. The Sr Quality Engineer is responsible for documentation of the non-conformances, identification of population, containment of population, and communication of non-conformance to applicable parties.
• Support and drive proper change control procedures and collaborate with change owners on their implementation
strategies and change documentation.
• Facilitate group meetings and project leadership that drives comprehensive technical solutions for multiple issues and
projects simultaneously
• Communicate clearly regarding technical issues and solutions
• 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.
  TECHNICAL SKILLS
Must Have

• Experience with general quality principles, procedures and methodologies
• Proficiency in Microsoft Office Applications (Word, Excel, Powerpoint, Teams)
• Strong background in Equipment Development, IQ, Process Characterization,OQPQ, and Test Method Development and Validation.
• Strong overall communication, both in technical writing and presentation skills, as well as experience with presentation tools and applications
• Strong understanding of regulatory requirements (i.e.: ISO, FDA-GMP, etc.)
• Technical Structured Problem Solving methodologies (e.g. DMAIC, Ishikawa, 8D, etc.)

Nice To Have

• 4+ years of engineering experience in a medical device manufacturing environment
• 4+ years of Process Quality or Process Engineering experience.
• DRM or DFSS certification
• Experience with electronics manufacturing including wafer fabs and microelectronics assembly (SMT and/or chip and wire).
• Experience with internal and external audits including FDA, MDSAP and/or TUV.
• Six Sigma or Lean Sigma belt certification
• Strong statistical analysis techniques & DOE design and execution
• Strong understanding of medical device manufacturing processes and products

]]> Fri, 23 Jan 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
You’ll be the go-to person for everything from KOL engagement and event planning to adapting global materials for the UK market. You won’t be alone: our digital marketing team in our HQ handles creative, social, and campaign execution, while our European sales and training teams offer strong regional support.

What You’ll Be Doing

• Localising global marketing strategies and materials for the UK healthcare landscape
• Planning and executing conferences, workshops, and clinical events
• Building relationships with key opinion leaders and hospital stakeholders
• Collaborating with global and regional teams to ensure brand consistency and market relevance
• Feeding UK insights back into global strategy

What You’ll Bring

• 3–5 years of marketing experience in TAVI and cardiology, focused on the UK market
• Strong track record of adapting global campaigns to local needs
• Experience managing events, KOLs, and clinical engagement
• Confident communicator, proactive collaborator, and strategic thinker
   

Why This Role Stands Out

• You’ll be the face of UK marketing—trusted to lead, shape, and grow
• Backed by a global team and regional infrastructure
• Competitive salary and performance incentives

A chance to make a real impact in a fast-evolving space]]> Thu, 15 Jan 2026 00:00:00 EST 1 This position will design and develop software for a medical instrument running iPad OS for clinical applications. Work will involve design and development of new code as well as debugging and refactoring of legacy code.  Candidate must be skilled in Objective C, C, JavaScript, multi-threading and event driven software.  Additionally, experience with CSS, HTML, XML and JSON and Cordova framework would be helpful

Must Have:

• 4+ years of relevant experience.
• Expertise in Objective C, C and JavaScript programming.
• Experience working with iOS/iPadOS and apple eco system
• Experience working in client/ server model and working across other interfaces
• Experience resolving multitasking, multithreading issues.
• Sound debugging skills using Xcode IDE
• Ability to work in an agile cross functional team environment
• Strong Communication skills.

Requires a University Degree and minimum 4 years of relevant experience, 

Nice to have (one or more):

• Experience with CSS, HTML, XML and JSON
• Experience with Cordova framework
• Experience with legacy code refactoring

]]> Tue, 13 Jan 2026 00:00:00 EST 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, 12 Jan 2026 00:00:00 EST 1 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.

---

  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.

]]> 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.

---

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.

---

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.

---

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 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 Laboratory Information Systems (LIMS) Specialist – Fully Remote in Ireland

Are you a driven LIMS expert looking to make a significant impact within the biotech or pharmaceutical sectors? We are seeking a highly skilled Laboratory Information Systems (LIMS) Specialist to join a dynamic team on a fully remote basis in Ireland. This crucial role offers an exciting opportunity to contribute to cutting-edge projects within a collaborative environment, supporting the deployment, optimization, and management of Laboratory Information Management Systems that drive innovation and efficiency.

What You'll Do:
As a LIMS Specialist, you will be the key technical authority for the implementation, configuration, and maintenance of the Laboratory Information Management System. Your expertise will support laboratory workflows, data integrity, and compliance standards, ensuring seamless operation within a fast-paced, evolving scientific setting. You'll collaborate closely with cross-functional teams to troubleshoot issues, develop solutions, and optimize system performance—all remotely.

Required Skills:

• Solid experience with Laboratory Information Management Systems, preferably in a regulated environment
• Strong troubleshooting and problem-solving abilities
• Proficiency in system configuration and implementation of LIMS solutions
• Knowledge of data management, validation protocols, and compliance requirements
• Excellent communication skills to liaise effectively with technical and non-technical stakeholders
• Ability to work independently and manage multiple priorities remotely

Nice to Have Skills:

• Familiarity with specific LIMS platforms (e.g., Thermo Fischer, LabWare, STARLIMS)
• Experience with integrations between LIMS and other laboratory instruments
• Knowledge of quality assurance standards (e.g., GMP, GLP)
• Previous exposure to validation documentation and audits

Preferred Education and Experience:

• Bachelor’s degree in Life Sciences, Chemistry, Bioinformatics, or related field
• Minimum of 3 years’ experience working with Laboratory Information Management Systems in a regulated environment
• Prior experience working remotely or in a distributed team

Other Requirements:

• This position is fully remote, so reliable internet and a suitable home office setup are essential
• Willingness to adapt to project start as soon as possible
• Valid right to work in Ireland

If you're ready to bring your LIMS expertise to a stimulating project with a forward-thinking organization, this is your opportunity. Take the next step in your career and apply now to be part of a innovative team shaping the future of scientific research.
]]> Wed, 17 Dec 2025 00:00:00 EST 1 Position: Senior Manager – Biostatistics
Location: Tokyo, Japan
Employment Type: Permanent, Full Time

Role Overview
A global clinical research organisation is seeking an experienced Senior Manager of Biostatistics to support medium to high-complexity clinical trial programs across Phase I–IV. This role sits within a well-established biostatistics function and combines hands-on technical contribution with leadership and process improvement responsibilities.
The position will play a key role in statistical analysis, regulatory submissions, and cross-functional collaboration, with scope to mentor and supervise junior team members.

Key Responsibilities

• Lead the generation of analysis datasets and statistical analyses for medium to high-complexity clinical trials
• Support Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), and electronic regulatory submissions
• Contribute to the development and optimisation of statistical and analytical processes
• Provide leadership and guidance on data management, analysis, and reporting challenges
• Apply and advise on appropriate statistical methodologies across Phase I–IV studies
• Stay current on relevant technical and regulatory developments and advise management accordingly
• Supervise and mentor other biostatistics team members, as appropriate

Required Experience & Qualifications

• PhD in Biostatistics, Statistics, or a related discipline
• 7+ years of experience in pharmaceutical clinical trials
• Strong hands-on experience with SAS programming (or equivalent statistical software)
• Solid understanding of advanced statistical methods applied to Phase I–IV studies
• Experience supporting regulatory submissions, including ISS and ISE
• Strong knowledge of global regulatory requirements and drug development processes

]]> Tue, 16 Dec 2025 00:00:00 EST 1 HM's Top Needs:

1.?Experience with Requirements Management

2. Experience with Medical Device Software (at least 5 years)

3. Medical Device experience is highly preferred

 

Candidate will have experience in Medical Device product development.  I am looking for a versatile engineer that can execute a varity of Systems Engineering tasks with an expansion into Software design history file management.   The tasks included:  Requirements Management, Verification Trace Matrices, Protocol Creation, Test Execution, and Report Creation. An understanding of Medical Device quality systems is ideal, with experience in Design Verification and Validation.  I would like someone that can start with a list of requirements, draft a test protocol to verify each requirement, execute the testing, and write the final report.

 

Additionally, I would like someone that has experience with the Medical Device Software Lifecycle, specifically with the IEC 62304 Software Lifecyle Standard.  I am not looking for someone to develop software, just experience with it such that they can manage our software design history files.

 

• 
  Experience with JAMA software would be a plus
  

 

Education Required:  BS in engineering, Computer Science

Years’ Experience Required: 5 years minimum, 10 + Ideally

 
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.

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: Recognized master in professional discipline. Works independently to implement strategic goals and establish operational plans for job area. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results.

Organizational Impact: Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results. Implements strategic goals established by functional leadership. Changes or may establish operational plans for job area with long-range impact on results.

Innovation and Complexity: Faces problems that span a wide range of difficulty and unique issues across functions and / or businesses which may cause redirection. Develops solutions to unique issues. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation.

Communication and Influence: Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant matters. Conducts briefings with senior leaders within the job function. Negotiates with others to reach understanding or agreement.

Leadership and Talent Management: Frequently provides guidance, coaching and training to other employees. Typically manages large, moderately complex initiatives of strategic importance to the organization, involving large cross-functional teams.

Required Knowledge and Experience: Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience. May have deep 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 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience. ]]> Wed, 10 Dec 2025 00:00:00 EST 1 Join the Movement as an Sales Account Manager (Animal Health) – Based in Ireland

Are you passionate about transforming the animal health landscape through innovative marketing strategies? We are seeking a dynamic and experienced Sales Account Manager to lead cutting-edge campaigns in the vibrant Irish market. This pivotal role offers the chance to shape brand presence across multiple channels, ensuring animal health products reach and resonate with our target audiences. If you thrive in a fast-paced environment and have a passion for animal wellness, this is your opportunity to make a real impact.

What You’ll Bring to the Table:

• Proven experience (minimum 2 years) in veterinary product sales, specifically within the companion animal segment, in Ireland.
• Strong understanding of omnichannel marketing strategies, including digital, social, and traditional channels.
• Exceptional project management skills with the ability to coordinate cross-functional teams.
• Excellent communication and stakeholder engagement abilities.
• Analytical mindset to interpret data and optimize marketing efforts effectively.
• A proactive approach with the ability to adapt and innovate in a dynamic environment.

Nice to Have:

• Experience working with animal health or veterinary pharmaceutical products.
• Knowledge of Irish market regulations and compliance standards.
• Familiarity with marketing automation tools and CRM systems.
• Previous experience in healthcare or related industries.

Preferred Education & Experience:

• Bachelor’s degree in Marketing, Animal Science, Veterinary Studies, or a related field.
• At least 2 years of hands-on experience in companion animal veterinary product sales or marketing.

Additional Requirements:

• This role is remote-based within Ireland, with a possibility of being required onsite for interviews.
• Willingness to engage in a 6-month contract with potential for extension.
• Eligibility to work in Ireland without restrictions.
• A passion for animal health and a desire to contribute to improved pet welfare.

If you’re ready to take your marketing expertise to the next level and make a meaningful difference in the animal health industry, we want to hear from you. Apply now to embark on this exciting journey and help shape the future of companion animal care.
]]> Fri, 05 Dec 2025 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 Exciting Opportunity: Technology Transfer Engineer (Drug Substance) - County Louth 

Join Our Dynamic Technical Operations Team and Play a Key Role in Biopharmaceutical Innovation

We are seeking a highly motivated and experienced Technology Transfer Engineer to support our Drug Substance Manufacturing Science & Technology (MS&T) team. In this pivotal role, you'll contribute to the seamless transfer and optimization of biological drug manufacturing processes, ensuring the continued success and compliance of our global operations. This is a fantastic chance to be part of a fast-paced environment, working alongside industry-leading SMEs, and influencing critical phases of biological drug development and production.

What You’ll Bring to the Role

• Minimum of 3 years’ post-bachelor's experience in a GMP-related function such as Operations, Technical Support, Engineering, or Maintenance
• 2-3 years’ hands-on experience working with biological drug substances
• Proven ability to manage projects independently and meet deadlines
• Strong communication and team collaboration skills
• Knowledge of GMP documentation processes, change control, deviation management, and statistical process analysis

Additional Valuable Skills

• Experience in deviation management, equipment support, or process optimization projects
• Proficiency in statistics and continuous process verification
• Familiarity with regulatory inspections, GMP standards, and process validation practices

Preferred Education & Experience

• Bachelor’s degree in Life Sciences, Chemical Engineering, Biotech, or related fields
• Previous exposure to biologics manufacturing and tech transfer activities

Other Requirements

• Ability to work in a fast-changing project environment capturing surge activities planned for 2026

This role offers a 12-month contract, full-time hours (39 per week), and competitive pay aligned with industry standards. If you're motivated to contribute to cutting-edge biological manufacturing and thrive in a collaborative environment, we encourage you to apply now. Take the next step in your career and help shape the future of biopharmaceutical innovation!
]]> Wed, 12 Nov 2025 00:00:00 EST 1 Join Our Team as an EHS Project Engineer in County Louth – Drive Safety and Sustainability in a Cutting-Edge Pharmaceutical Environment

Are you a seasoned EHS professional with a passion for advancing safety standards in high-risk manufacturing settings? We are seeking two dedicated EHS Project Engineers to support innovative pharmaceutical projects. This strategic role offers the chance to make a meaningful impact on environmental health and safety initiatives within a leading industry operational hub. If you thrive in challenging environments, possess robust project management skills, and enjoy collaborating across functions, this opportunity could be your next career move.

What You’ll Bring:

• Minimum of 5 years’ experience in environmental health and safety within pharmaceutical, biotech, or medical device manufacturing sectors.
• Proven expertise supporting capital projects, facility upgrades, and equipment installations with a focus on EHS integration.
• Strong knowledge of GMP environments and cleanroom operations.
• Technical proficiency in construction safety, process safety management, chemical management, and hazard identification.
• Experience conducting risk assessments, PSSRs, incident investigations, and managing safety documentation.
• Excellent stakeholder engagement and communication skills to liaise effectively with diverse teams and regulatory bodies.

Additional Skills That Set You Apart:

• Certifications such as ATEX, Machinery, or Process Safety Management (PSM).
• Advanced degrees (MSc, MEng) in relevant disciplines.
• Knowledge of gas safety, hazard classification, and environmental permitting.
• Experience in GMP-regulated environments and supporting regulatory audits.

Preferred Education & Experience:

• Bachelor’s degree in Environmental, Chemical, or Occupational Safety Engineering, Industrial Hygiene, or related field.
• Advanced certifications and significant hands-on experience supporting complex manufacturing projects.

This is your chance to leverage your expertise in a dynamic, high-stakes environment that values safety and innovation. If you’re ready to contribute to a world-class pharmaceutical operation and help shape sustainable safety practices, we encourage you to apply now and take the next step in your career.
]]> Mon, 10 Nov 2025 00:00:00 EST 1 Senior Process Engineer based in County Carlow

Join a dynamic team as a Senior Process Engineer, where your expertise will drive innovative manufacturing processes and operational excellence. This pivotal role offers an exciting opportunity to contribute to cutting-edge projects within a collaborative environment, supporting the company's commitment to quality, efficiency, and continuous improvement. If you are a motivated professional with a passion for process engineering, this position is your chance to make a significant impact and advance your career.

Required Skills:

• Proven experience in process engineering within a manufacturing or industrial setting
• Strong analytical and problem-solving abilities
• Expertise in process optimization, lean manufacturing, or Six Sigma methodologies
• Excellent understanding of process control, automation, and equipment integration
• Effective communication skills and ability to work collaboratively across teams
• Proficient in relevant engineering software and tools

Nice to Have Skills:

• Knowledge of regulatory standards and compliance in manufacturing environments
• Experience with project management and process improvement initiatives
• Understanding of automation systems and advanced manufacturing technologies
• Prior experience working within a multidisciplinary engineering team

Preferred Education and Experience:

• Bachelor's degree or higher in Chemical, Mechanical, Process, or Industrial Engineering
• Minimum of 5 years' experience in a process engineering role, preferably within a similar industry

Other Requirements:

• Ability to liaise with and prepare documentation for relevant authorities

If you're ready to bring your expertise to a forward-thinking organization and thrive in a challenging yet rewarding environment, we encourage you to apply now. Take this opportunity to elevate your career and contribute to exciting projects in Carlow.
]]> Wed, 05 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 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 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 HM's Top Needs:

1. 
    Blue Yonder  /  JDA Technical  /  Deployment experience with ESP (not WMS Not TMS)
   
2. 
   Functional experience  (as a planner/ buyer / scheduler)
   
3. Worked on large projects

Education Required: Bachelors

Years’ Experience Required: 5+

 

Role of a Supply Chain Project Analyst   Blue Yonder ESP / IO rollout

Expertise in supply chain management, project leadership, and collaboration to drive continuous improvement and innovation in supply chain processes.

• Role Overview and Purpose: The position requires a supply chain subject matter expert with strong project management and collaboration skills to support and optimize the company's global supply chain through process and technology improvements. The analyst will work within the Global Supply Chain Center of Excellence to develop and execute strategies that enhance innovation, growth, and profitability. 
• Key Responsibilities: Responsibilities include identifying system and process improvement opportunities, leading corporate projects, gathering business requirements, analyzing problems, collaborating across teams, developing training materials, and overseeing testing and implementation of system enhancements. The role demands innovative thinking and cross-functional coordination. 
• Qualifications and Experience: Candidates should hold a bachelor’s degree in relevant fields, with knowledge in multiple supply chain areas such as demand planning and materials planning. Experience with SAP, APO, or Blue Yonder systems and certifications like APICS, Lean Sigma, or Project Management Professional are preferred. The role typically requires 10 years of work experience or 8 years with an advanced degree. 
• Skills and Physical Requirements: Essential skills include enterprise ERP, advanced planning solutions, quantitative aptitude, systems thinking, Microsoft Office proficiency, project management, and agile development. The position requires up to 25% travel, including international trips. 

The Project analyst will join a team working to redefine the business processes and technology used to plan the supply chain.

 Project analyst will work in the Global Supply Chain Center of Excellence organization and be responsible for providing analysis, leadership and support working in the development and execution of continuous improvement and long-term strategies that will optimize the company's innovation, growth, and profitability goals.

The project analyst will support the end-to-end supply chain through the innovation, design, implementation, continuous improvement, maintenance, and support of Supply Chain Systems. This position will work to build communities of users, develop, and deploy and drive and adoption standard processes “global design.”  They will work closely with core process teams (IT), business groups, and commercial teams(regions) to understand requirements and solutions and provide governance. The position is a project manager / analyst role; it provides the opportunity to work across regional, functional, and commercial franchise boundaries. This position requires innovative thinking, consulting skills and collaboration. Applies mastery of in-depth knowledge in one area or broader expertise in many areas of the supply chain function. Considered an internal expert within an area.

Responsibilities

·         Identify improvement opportunities for current systems, planning, and reporting methods.

·         Support or lead corporate projects / initiatives- develop the approach, communicate plans and tasks to operational, divisional, and global participants, manage projects / initiatives to timeline, and successfully achieve projects’ / initiatives’ goals.

·         Communicate relationships and constraints between people, processes, business requirements and systems

·         Work independently on development and execution of plans

·         Lead or co-lead business requirements gathering and design sessions for new platforms, applications, and enhancements

·         Prepare / Review Detailed Requirements Documents and use cases

·         Evaluate causes as well as effects of business problems, analyze options, and propose solutions

·         Collaborate with varied business or system analysts, project team and business performing through project and organizational needs

·         Supply expertise on subject matter on supply chain processes and applications.

·         Develop process and training documents

·         Understand and stay current in trends in the solution space to ensure solutions meet long-term objectives

·         Lead/Coordinate testing and implementation of key system enhancements

·         Lead/Coordinate efforts of project estimation for review with cross organization technical as well as business teams
]]> Thu, 23 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