Job#: 3026784 Job Description: Our Boston based biotechnology client is seeking a highly skilled Senior or Principal Scientist to lead the development, transfer, and validation of bioassay methods supporting innovative gene therapy programs. This role is ideal for a scientifically driven professional who thrives in a dynamic, collaborative environment and is motivated by impactful work in clinical-stage development. This position requires 2-3 days per week onsite in Boston, MA.
About the Role
The incumbent will be responsible for establishing and managing biological potency assays used for release and stability testing. This position also oversees CRO activities for both GMP and non-GMP sample testing, ensuring high-quality execution and regulatory compliance.
You will collaborate closely with cross-functional teams, contribute to analytical CMC documentation, and support regulatory submissions. This is a high-impact role with opportunities to influence analytical strategy and drive scientific excellence.
Key Responsibilities
- Lead development, transfer, and validation of biological assays for release and stability testing.
- Manage laboratory investigations, OOS assessments, and data trending; support manufacturing investigations.
- Execute development studies for process and product characterization, including comparability assessments.
- Draft, review, and approve SOPs, protocols, reports, and analytical documentation for internal and external QC labs.
- Support preparation of analytical CMC content for regulatory submissions, including data summaries and trend analyses.
- Collaborate effectively with internal stakeholders and manage external CRO relationships.
Skills and Expertise
- Strong technical expertise and hands-on experience with cell-based potency assays.
- Familiarity with statistical analysis tools (e.g., JMP, Prism, PLA 3.0) is an asset.
- Excellent technical writing skills for analytical CMC documents, including change controls, SOPs, protocols, and reports.
- Solid understanding of regulatory guidance and GMP requirements for analytical method lifecycle management.
- Highly organized, detail-oriented, and capable of strategic thinking.
- Strong teamwork, communication, and collaboration skills.
Required Qualifications
- MS or PhD in Biological Sciences or related field, with a minimum of 10 years of biotech/pharma industry experience.
- Extensive hands-on experience in analytical method development, validation, and clinical-stage sample testing.
- Strong background in analytical documentation within a regulated environment.
- Proficiency in cell-based assays, ddPCR, and ELISA is required.
- Experience with HPLC/UPLC or CE-SDS is a plus.
- Demonstrated project management, problem-solving, and organizational skills.
- Experience managing CDMO/CRO partnerships is required.
- Excellent written and verbal communication skills, with the ability to present findings to diverse stakeholders.
About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
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