https://CAREERS.PLANET-PHARMA.COM/ en-us
Job Details:

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

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

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

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

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

Experience with both ESI and MALDI techniques would be useful

Communicate (verbal and in written) scientific concepts and results

Work independently in advancing projects and studies within required deadlines

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

Basic Qualifications:

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

Or

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

Preferred Qualifications

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

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

Knowledge of statistical processing of data, including related software such as, but not limited to Excel, Spotfire or JMP is preferred]]> Fri, 10 Apr 2026 00:00:00 EDT 1
As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to the aseptic fill finish manufacturing plants at Thousand Oaks and which includes various production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of products. The candidate will assist to establish the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

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

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

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


Preferred Qualifications
* Master's degree in Analytical Chemistry, Physical or Pharmaceutical or Life Sciences or Engineering related discipline.
* Strong theoretical understanding, research in, and hands-on experience in small molecule/peptide analysis in support of process development/scale up activities and formulation development in GMP and non-GMP environments
* Experience with a broad array of chromatographic and spectroscopic techniques.
* Demonstrate independence and ability to produce quality results under minimal direction
* Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook
* High energy individual who can multi-task and handle a fast-pace, dynamic work environment
* Operate specialized laboratory equipment and instrumentation
* Perform general laboratory housekeeping activities
* Complete training on assigned tasks
* Comply with safety guidelines and site specific procedures which include but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books]]> Thu, 09 Apr 2026 00:00:00 EDT 1 Job Summary

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

Essential Functions

 

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

Required/Preferred Education and Experience

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

Knowledge, Skills and Abilities

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

Physical Demands

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

Working Conditions

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

]]> Thu, 09 Apr 2026 00:00:00 EDT 0
This position reports into the Packaging Engineering group under Combination Products Operations (CPO) in Thousand Oaks, CA. This position will apply engineering principles to execute the proper design, qualification and implementation of Primary and Secondary Packaging components and the associated systems such as documentation, equipment, and processes. Knowledge of primary and secondary packaging systems and material science is essential to the position. The position requires organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to rapidly changing environment. Day to day commercial support, and Lifecycle Management.

This position is responsible and accountable for the following:

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

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

Preferred Qualifications:

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

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

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

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

Lets do this! We strive to serve every patient, every time.
In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO B20 - you will be responsible for the introduction of new products into the manufacturing plant. This Specialist Manufacturing role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20.
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 with a clinical and commercial product mix has to the network. This role will function as a vital interface between the 5 key functions that enable the B20 plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines.
Candidates will need to demonstrate knowledge of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team.

The NPI Lead will be primarily responsible for:
• Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.

Additional Responsibilities include:
• Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
• Representing the team at plant-wide and network-wide forums, as needed.

Preferred Qualifications:
• Project Management experience
• Direct and/or indirect people management / leadership experience
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)]]> Tue, 07 Apr 2026 00:00:00 EDT 1

Seeking an External Automation Engineer based in Thousand Oaks, California to augment our MCS F&E Automation team. This role will support ongoing biological processes by updating, maintaining, and improving DeltaV automation systems, and providing critical site support. The successful candidate must exhibit sound analytical thinking and problem-solving skills, exemplary communication and collaboration, and operational excellence. A proven ability to work in cross-functional teams is critical for this role.

Preferred Qualifications:
• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech
Engineering.
• Extensive understanding and background in programming, design, installation and lifecycle
management of manufacturing process controls, automation and field instrumentation
technologies.
• Demonstrated hands-on experience in developing process control strategies for New
Product Introduction and New Technology Deployment for Clinical and Commercial Drug
Substance Plant Operations.
• Direct knowledge of Automation design, experience in process control engineering and
troubleshooting with GMP biopharmaceutical production facility equipment/systems such
as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration,
and integrating various OEM automation software.
• Demonstrated experience with continuous improvements resulting in enhanced safety,
system reliability, and productivity (e.g. cycle times, and reduced plant utilities usage etc.)
related to Drug Substance Plant Operations.
• 5+ years combined experience with the following:
Emerson Delta-V DCS system
Rockwell Automation SCADA and PLC Platform.
Electronic Batch Reporting Systems Design and implementation
experience.
Process Control Network design including network segregation
Process Control Systems: Virtual Infrastructure design and
implementation and ability to perform advanced troubleshooting activities
with IS.
System Integration using OPC, Foundation Fieldbus, Profibus,
and DeviceNet technologies.
Compliance and regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.

• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost
estimate development, business case development, detailed design, engineering and
validation documentation and project execution.
• The ideal individual must be a self-directed team player ready to mentor and develop
engineering staff and embrace a team-based culture that relies on collaboration for
effective decision-making.
• Strong leadership, technical writing, and communication/presentation skills.
Ability to perform independently, self-motivated, organized, able to multi-task in project
environments, and skilled in communication, facilitation, and collaboration.]]> Tue, 07 Apr 2026 00:00:00 EDT 1 *depending on experience

Responsibilities
• Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).
• Create and maintain component specifications for vials, stoppers, syringes, seals, cartons, labels, and distribution packaging.
• Develop and execute packaging test protocols including:
o Transportation simulation (ISTA/ASTM)
o Aging and shelf-life studies
o Cold-chain and environmental conditioning
o Packaging line engineering studies
• Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).
• Prepare and review packaging documentation for regulatory submissions.
• Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs.
• Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
• Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications.
• Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements.
________________________________________
Basic Qualifications
• Bachelors degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
• 7+ years of packaging engineering experience in biopharmaceutical, pharmaceutical, or medical device environments.
• Strong understanding of cGMP, sterile product packaging, and biologics/combination product considerations.
• Experience with packaging validation and ISTA/ASTM distribution testing.
• Excellent communication skills and ability to collaborate across functions.
• Ability to work onsite at Thousand Oaks campus.
________________________________________
Preferred Qualifications
• Masters degree in Engineering or related field.
• Experience with combination products, injection devices, and cold-chain distribution systems.
• Knowledge of paperboard, structural design & FEA]]> Tue, 07 Apr 2026 00:00:00 EDT 1
Job Details:

Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for automation related scope. Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution by third party firms. Assist with project definition by performing engineering studies and assessment for automation system installations. Perform field evaluations of existing systems and provide engineering design recommendations.;

Skills: previous intern experience is a plus? experience with automation is a plus, as well as experience with computer programming, systems, and/or robotics.

Day to Day Responsibilities:
• Supports ongoing hands-on lab-based development in visual inspection process development (i.e. development and maintenance of defect standards and panels, establishment of GMP procedures related to operations)
• Implements and documents off-line and on-site drug product characterization studies
• Author and/or own high-quality process technology transfer and other technical documents.

Additional Job Description:
As a member of the process development team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.

Key responsibilities include:
• Supports ongoing development in the area of visual inspection (i.e. development and maintenance of defect standards and panels, establishment of GMP procedures related to operations)
• Supports the establishment of robust tactical and strategic objectives related to visual inspection
• Implements and documents off-line and on-site drug product characterization studies
• Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
• Support one or more clinical and commercial process introductions or process transfers into manufacturing network

Preferred Qualifications
• 3+ years of experience within the pharmaceutical/biotechnology industry
• Experience in development/characterization of drug product unit operations, especially visual inspections
• Understanding of process related stresses that impact the quality and stability of biologics
• Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
• Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
• Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
• Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
• Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
• Ability to learn and act on dynamic information at a rapid pace
• Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
• Laboratory or pilot plant experience with process equipment

Basic Qualifications
• Masters degree
• Bachelors degree and 2 years of engineering and/or operations experience
• Associates degree and 4 years of engineering and/or operations experience
• High school diploma / GED and 6 years of engineering and/or operations experience]]> Mon, 06 Apr 2026 00:00:00 EDT 1
The ideal candidate will have 1-2+ years of hands-on experience in a regulated GMP environment, preferably within the pharmaceutical, biotech, or food industries. While a bachelors degree in a relevant scientific field (e.g., biology, chemistry, biochemistry) is preferred, direct industry experience is more important. Candidates should be familiar with manufacturing or quality operations and understand the pace and expectations of a high-volume, highly cross-functional environment. This role requires individuals who are proactive, able to work independently with minimal oversight, and comfortable escalating issues appropriately. Candidates seeking long-term opportunities with potential for FTE conversion will be prioritized; this is not intended for short-term or transitional job seekers. Fresh graduates without industry experience will not be considered.

This position supports Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations . Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Preferred Qualifications:
• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field.
• Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.
Also, ability to make Quality based decisions in order to ensure compliance.
• Experience managing projects through to completion & meeting timelines.
• Evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives.]]> Mon, 30 Mar 2026 00:00:00 EDT 1 The Project Manager (PM) supports Global Program Managers by contributing to the maintenance of project documentation, including timelines, meeting materials, and risk registers. This role is primarily focused on operational coordination, tracking project deliverables, and facilitating execution activities under the direction of senior program leadership.

Job Responsibilities
•Monitor and communicate progress on project deliverables, key milestones, and potential risks.
•Support the creation and maintenance of project documentation, including schedules, meeting summaries, and action item trackers.
•Organize and facilitate team meetings, develop agendas, and ensure follow-up on assigned actions.
•Manage SharePoint access for project teams.
•Partner with functional leads to drive timely execution of tasks and deliverables.
•Identify and escalate issues and risks to senior program managers.
•Update and maintain functional plans utilizing Planisware.
•Maintain accuracy and currency of project management systems and tools.
•    May support Development organization process improvement work streams.

Basic Requirements 
•Bachelor’s degree in life sciences, business or related discipline, and 3+ years of pharmaceutical/biotech experience

Preferred Qualifications 
•Proven experience in project management or operational roles within the pharmaceutical or biotechnology sectors.
•Solid understanding of drug development processes and team collaboration dynamics.
•Exceptional organizational and communication abilities.
•Strong analytical and problem-solving skills, with a keen eye for detail and a proactive approach to troubleshooting.
•Excellent interpersonal, written, and verbal communication skills, with the ability to collaborate effectively and influence outcomes without direct authority.
•Background in oncology or cell therapy is a plus, though not required.
•Experience working with enterprise planning tools; familiarity with Planisware is preferred.
•Experience with SharePoint.

6+ years of relevant experience and a BA or BS or; 4+ years of relevant experience and a MS or MBA Relevant experience consists of work in a scientific field or equivalent experience in association with R&D project teams and/or in cross-functional project management activities.

Pay ranges between 58-63/hr based on experience ]]> Tue, 24 Mar 2026 00:00:00 EDT 1 Provides operational support for global pharmacovigilance activities for investigational and marketed products. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Responsible for data analysis and management obtained from the integrated database utilized by worldwide pharmacovigilance personnel. Responsible for project implementation and execution of system, including responsibilities for providing safety ongoing business support and ongoing improvements. Key interface with the IT system administrators to verify and test system changes, ensuring that the system is compliant and meets business needs.
The personnel who cover the workplace will develop their activities according to the Pharmacovigilance System Master File (PSMF), Standard Operating Procedures (SOPs) and Working Practices (WPs) and following the Pharmacovigilance legislation

Responsibilities:
Coordinate and participate in the safety data analysis, review, processing and evaluation in order to prepare aggrega 1. Process and review safety data to develop aggregate safety reports
2. Support to respond to requests from regulatory agencies
3. Coordinate and manage creation of queries for data extraction used in different PV documents
4. Develop training documentation and/or work instructions to determine methods and procedures
5. Work as Signal Analyst during signal management activities including extractions of signal detection reports ensuring document filing and archiving Ensure quality and compliance with the legal requirements for pharmacovigilance tasks and responsibilities. 1. Take part in self-inspection visits, audits, inspections and in CAPAs management
2. Coordination and management of aggregate safety reports submissions; notifies Regulatory Affairs and business partners accordingly
3. Interact with Regulatory Affairs Department as it relates to aggregate safety documents required by Regulatory Authorities
4. Review legislation to ensure compliance with local regulatory Authorities requirements
5. Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards
6. Management of documentation describing PV applications use, which may include, but not limited to: SOPs, WP, User requirements, functional and/or technical specifications, process flow diagrams
7. Lead change management actions to assure PV team smoothly adapts to the new processes, as well as supporting the integration of a new application
8. Gathering, prioritizing, and planning improvements based on user requests, taking into account overall regulations to the business PV data base operating activities 1. Provide support in the updates in the database configuration of submission rules to Regulatory Authorities
2. Provide support in the updates in the database configuration of products and studies
3. Support drug safety applications with business administration tasks. Key project team technical expert to deliver solutions that are cost effective, sustainable, and meet business requirements Scientific and medical literature review 1. Define with the Knowledge Services Department the strategy of scientific searches that are performed
2. Review scientific literature and bibliographic search results and determine the actions necessary to be taken therewith
Experience:
Drug Safety Analyst should ensure their knowledge of pharmacovigilance practices; existing legislation, regulations and guidelines; medical coding and safety-data administration. Drug Safety Analyst should have a university degree in health sciences/ biosciences and additional training in IT or have a university degree in IT with additional training and/or experience in pharmacovigilance. At least 2 years of relevant experience in pharmacovigilance and 2 years of relevant experience in managing data bases, is usually required. Availability for international travelling when necessary is also required.

Needed Skills: - Proven Self-starter with strong work ethic and the ability to exercise good judgment.
- Ability to work independently with minimum supervision.
- Must be proactive, results oriented, and have strong attention to detail.
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
- Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
- Must possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
- Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines
-Proficient in Windows 7 and MS Office (Excel, PowerPoint, Visio, Word)
- Familiarity with validation of computer systems and/or GMP environments is essential.
- Knowledge of E2b (R2) and E2b (R3) is beneficial. Familiarity with Medical terminology, MedDRA,WhoDrug is beneficial
- Familiarity with reporting tools such as Business Objects is strongly preferred.





  Pay Rate Range: $30-45/hr depending on experience  ]]> Tue, 17 Mar 2026 00:00:00 EDT 1
Manufacturing and Clinical Supply (MCS) – Facilities & Engineering (F&E) Automation team, is looking for Engineers to support Clinical & Commercial Plant Automation programs and Capital projects, including complex and challenging automation initiatives that require a solid understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, product lifecycle management, and operational excellence. They will require an extensive understanding and background in capital construction projects, design, programming, implementation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

Job Responsibilities:
1) Support automation capital project software development testing, commissioning activities etc.
2) Support day to day operations of the plant for automation related issues including on call rotation every 7-8 weeks.
3) Support Plant Automation team and participate in the preparation and implementation of detailed design, scope, schedule in partnership with cross functional teams.
4) Support Plant Automation team during the project implementation of new automation solutions including DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA) related hardware, software, network infrastructure, and electronic Rt-reporting scope across various projects.
5) Support Plant Automation team during the post-implementation activities including operationalization of the new assets by extending hyper-care support, training the System Owners, and Manufacturing team, revising the SOPs, and training documents, delivering spare parts list, updating Maximo assets and  CMDB systems.
6) Ensure compliance to Engineering and Operational standards, specifications, and procedures as applicable during the project design and implementation.
7) As applicable to the capital project scope, represent Plant Automation team and support new continuous improvements by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs.
8) Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.

Preferred Qualifications:
1) Degree in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
2) Knowledge and experience in capital project lifecycle management including conceptual design, scope, resource estimate & cost estimate development, business case development, detailed design, engineering, commissioning, validation, and project execution, as it relates to Plant Automation and process control systems with GMP biopharmaceutical production facility equipment/systems in support of Drug Substance, Drug Product plant operations.
3) Has five or more years combined experience with the following automation systems:
o Emerson Delta-V DCS system.
o Rockwell Automation SCADA and PLC Platform.
o ABB Robot and Mitsubishi roller bottle machine
o Emerson Delta-V DCS system.
o Electronic Batch Reporting Systems Design and implementation experience.
o Process Control Network design including network segregation.
o Process Control Systems: Virtual Infrastructure design and implementation.
o System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
o Compliance to regulatory requirements such as 21 CFR Part 11, ASTM 2500, S88, S95 and GAMP.]]> Tue, 10 Mar 2026 00:00:00 EDT 1 Tue, 10 Mar 2026 00:00:00 EDT 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