Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy
Bristol Myers Squibb
5 days ago
Remote friendly (Seattle, WA)
United States
Clinical Research and Development
Position Summary
The Principal Scientist is a highly experienced subject matter expert responsible for leading method optimization, transfer, and validation in support of the Cell Therapy analytical portfolio. Conceptualize and lead complex projects; apply technical knowledge, regulatory requirements, and scientific principles to independently troubleshoot and solve complex problems. Balance hands-on lab involvement with cross-functional leadership, mentoring, and external scientific engagement.
Duties/Responsibilities
- Lead method technical investigation, method optimization/remediations, method transfer, and method validation (Cell/Molecular Biology) in compliance with regulatory requirements.
- Independently develop, write, and execute methods, protocols, reports, and related documents aligned to regulatory and corporate guidelines.
- Independently lead complex projects/investigations/corrective actions/continuous improvement; design and execute lab experiments; evaluate data; identify risks and impact.
- Represent department in product review boards and regulatory inspections; own/author analytical sections of regulatory submissions and responses to health authority questions.
- Implement method lifecycle/maintenance programs for viral vector and cell therapy drug products.
- Partner on development/qualification studies, reagent selection/characterization, and method optimization.
- Represent ASAT on cross-functional/cross-site teams; communicate and collaborate effectively.
- Perform other tasks as assigned.
Qualifications
- Demonstrated advanced technical writing; advanced strategic thinking/problem-solving.
- Ability to work independently in a fast-paced matrix environment; prioritize multiple projects; track record of productivity (publications/presentations).
- Strong communication/collaboration globally.
- Strong hands-on lab skills; interpret complex multi-dimensional data for commercial QC analytical methods.
- Advanced mentoring/coaching/influencing.
- Expertise in analytical methodologies for lentiviral, AAV vectors, and other gene delivery platforms.
- Travel as needed.
- Education: BS/MS in (bioanalytical) science; advanced degree preferred.
- Experience: 10+ years in regulated cellular therapy or gene therapy.
- Expert bioanalytical methods (cell-based assays, ELISA, qPCR, flow cytometry) and method lifecycle (validation/transfer); training in method execution and instrument operation.
- cGMP and QC environment; knowledge of FDA/EMA/ICH/USP/EP for viral vectors, cell therapies, vaccines/biological products.
Benefits (as stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); disability and life insurance; other listed protections.
- Paid time off options (including flexible time off/unlimited for US Exempt employees; 160 hours vacation for certain roles), plus other potential leave time.
Compensation (as stated)
- Devens, MA: $124,590–$150,977; Seattle, WA: $128,090–$155,211.
Application instruction
- If the role interests you but doesn’t perfectly match your resume, apply anyway.
The Principal Scientist is a highly experienced subject matter expert responsible for leading method optimization, transfer, and validation in support of the Cell Therapy analytical portfolio. Conceptualize and lead complex projects; apply technical knowledge, regulatory requirements, and scientific principles to independently troubleshoot and solve complex problems. Balance hands-on lab involvement with cross-functional leadership, mentoring, and external scientific engagement.
Duties/Responsibilities
- Lead method technical investigation, method optimization/remediations, method transfer, and method validation (Cell/Molecular Biology) in compliance with regulatory requirements.
- Independently develop, write, and execute methods, protocols, reports, and related documents aligned to regulatory and corporate guidelines.
- Independently lead complex projects/investigations/corrective actions/continuous improvement; design and execute lab experiments; evaluate data; identify risks and impact.
- Represent department in product review boards and regulatory inspections; own/author analytical sections of regulatory submissions and responses to health authority questions.
- Implement method lifecycle/maintenance programs for viral vector and cell therapy drug products.
- Partner on development/qualification studies, reagent selection/characterization, and method optimization.
- Represent ASAT on cross-functional/cross-site teams; communicate and collaborate effectively.
- Perform other tasks as assigned.
Qualifications
- Demonstrated advanced technical writing; advanced strategic thinking/problem-solving.
- Ability to work independently in a fast-paced matrix environment; prioritize multiple projects; track record of productivity (publications/presentations).
- Strong communication/collaboration globally.
- Strong hands-on lab skills; interpret complex multi-dimensional data for commercial QC analytical methods.
- Advanced mentoring/coaching/influencing.
- Expertise in analytical methodologies for lentiviral, AAV vectors, and other gene delivery platforms.
- Travel as needed.
- Education: BS/MS in (bioanalytical) science; advanced degree preferred.
- Experience: 10+ years in regulated cellular therapy or gene therapy.
- Expert bioanalytical methods (cell-based assays, ELISA, qPCR, flow cytometry) and method lifecycle (validation/transfer); training in method execution and instrument operation.
- cGMP and QC environment; knowledge of FDA/EMA/ICH/USP/EP for viral vectors, cell therapies, vaccines/biological products.
Benefits (as stated)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k); disability and life insurance; other listed protections.
- Paid time off options (including flexible time off/unlimited for US Exempt employees; 160 hours vacation for certain roles), plus other potential leave time.
Compensation (as stated)
- Devens, MA: $124,590–$150,977; Seattle, WA: $128,090–$155,211.
Application instruction
- If the role interests you but doesn’t perfectly match your resume, apply anyway.