Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy
Bristol Myers Squibb
8 days ago
Remote friendly (Seattle, WA)
United States
Operations
Position Summary
The Principal Scientist is a highly experienced subject matter expert responsible for leading method optimization, transfer, and validation in support of Cell Therapy analytical portfolio. Leads complex projects, troubleshooting, and problem solving using technical, regulatory, and scientific expertise; balances lab work with cross-functional leadership and mentoring.
Duties/Responsibilities
- Lead method technical investigation, optimization/remediations, transfer, and validation for regulatory compliance.
- Independently develop, write, and execute methods, protocols, reports, and related documents.
- Conceptualize and lead complex projects, investigations, corrective actions, and continuous improvement (design and execute experiments; evaluate data; identify risks/impact).
- Represent department in product review boards; participate in regulatory inspections/audits; author analytical sections of regulatory submissions and responses to health authorities.
- Implement method lifecycle and maintenance programs for viral vector/cell therapy drug products.
- Partner with development organizations on development/qualification studies and method optimization.
- Represent ASAT on cross-functional/cross-site teams; collaborate and communicate effectively.
- Troubleshoot non-routine complex issues.
Qualifications (Education/Experience/Skills)
- Advanced technical writing; advanced strategic thinking/problem solving.
- Work independently in fast-paced matrix environment; prioritize multiple projects; track record of scientific productivity.
- Strong communication/collaboration with peers and senior leadership; advanced mentoring/coaching/influencing.
- Strong hands-on lab skills; interpretation of complex multi-dimensional data for commercial QC analytical methods.
- Molecular role: expertise in molecular biology methodologies (lentiviral, AAV vectors, gene delivery platforms).
- Travel as needed.
- BS/MS (bioanalytical science preferred); 10+ years regulated cellular therapy/gene therapy experience.
- Expert in bioanalytical/molecular techniques (cell-based assays, ELISA, qPCR, flow cytometry) and bioanalytical method lifecycle (characterization, validation, transfer); training experience for method execution and instrument operation/standardization.
- cGMP experience; knowledge of FDA/EMA/ICH/USP/EP guidelines for QC of viral vectors, cell therapies, vaccines, and/or biologics.
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k), disability, life/accident insurance, supplemental health, business travel protection, legal support, survivor support.
- Paid time off: flexible time off (unlimited with manager approval) and 11 national holidays (US exempt employees). Others may include 160 hours annual vacation and holidays.
Compensation Overview
Seattle, WA: $128,090–$155,211 (FTE); final pay based on experience; additional incentive cash/stock may be available (eligibility-dependent).
The Principal Scientist is a highly experienced subject matter expert responsible for leading method optimization, transfer, and validation in support of Cell Therapy analytical portfolio. Leads complex projects, troubleshooting, and problem solving using technical, regulatory, and scientific expertise; balances lab work with cross-functional leadership and mentoring.
Duties/Responsibilities
- Lead method technical investigation, optimization/remediations, transfer, and validation for regulatory compliance.
- Independently develop, write, and execute methods, protocols, reports, and related documents.
- Conceptualize and lead complex projects, investigations, corrective actions, and continuous improvement (design and execute experiments; evaluate data; identify risks/impact).
- Represent department in product review boards; participate in regulatory inspections/audits; author analytical sections of regulatory submissions and responses to health authorities.
- Implement method lifecycle and maintenance programs for viral vector/cell therapy drug products.
- Partner with development organizations on development/qualification studies and method optimization.
- Represent ASAT on cross-functional/cross-site teams; collaborate and communicate effectively.
- Troubleshoot non-routine complex issues.
Qualifications (Education/Experience/Skills)
- Advanced technical writing; advanced strategic thinking/problem solving.
- Work independently in fast-paced matrix environment; prioritize multiple projects; track record of scientific productivity.
- Strong communication/collaboration with peers and senior leadership; advanced mentoring/coaching/influencing.
- Strong hands-on lab skills; interpretation of complex multi-dimensional data for commercial QC analytical methods.
- Molecular role: expertise in molecular biology methodologies (lentiviral, AAV vectors, gene delivery platforms).
- Travel as needed.
- BS/MS (bioanalytical science preferred); 10+ years regulated cellular therapy/gene therapy experience.
- Expert in bioanalytical/molecular techniques (cell-based assays, ELISA, qPCR, flow cytometry) and bioanalytical method lifecycle (characterization, validation, transfer); training experience for method execution and instrument operation/standardization.
- cGMP experience; knowledge of FDA/EMA/ICH/USP/EP guidelines for QC of viral vectors, cell therapies, vaccines, and/or biologics.
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs; 401(k), disability, life/accident insurance, supplemental health, business travel protection, legal support, survivor support.
- Paid time off: flexible time off (unlimited with manager approval) and 11 national holidays (US exempt employees). Others may include 160 hours annual vacation and holidays.
Compensation Overview
Seattle, WA: $128,090–$155,211 (FTE); final pay based on experience; additional incentive cash/stock may be available (eligibility-dependent).