Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy
Bristol Myers Squibb
5 months ago
Remote friendly (Seattle, WA)
United States
Clinical Research and Development
Position Summary
The Principal Scientist is responsible for leading method optimization, transfer, and validation in support of the Cell Therapy analytical portfolio. Leads complex projects; provides strategic scientific/technical input; independently troubleshoots non-routine issues using technical, regulatory, and scientific principles. Balances hands-on lab work with cross-functional leadership, mentoring, and external scientific engagement.
Duties/Responsibilities
- Subject matter expert in Cell/Molecular Biology; leads method investigations, optimization/remediations, transfer, and validation per regulatory requirements.
- Independently develop, write, and execute methods, protocols, reports, and related documents aligned with regulatory/corporate guidelines.
- Conceptualize and lead complex projects/investigations/corrective actions/continuous improvement; design and execute experiments; evaluate data; identify risks and impact.
- Represent department in product review boards and regulatory inspections; author analytical sections of regulatory submissions and responses to health authority questions.
- Implement method lifecycle and maintenance programs for viral vector and cell therapy drug products.
- Partner with development organizations on studies/qualification, reagent selection/characterization, and method optimization.
- Represent ASAT on cross-functional/cross-site teams; communicate and collaborate effectively.
Qualifications
- Advanced technical writing.
- Advanced strategic thinking/problem-solving; technically logical.
- Ability to work independently in a fast-paced matrix; meet deadlines; prioritize multiple projects; track record of scientific productivity (publications/presentations/internal contributions).
- Strong communication/collaboration with peers, senior management, and cross-functional teams (local/global).
- Strong hands-on lab skills; execute and interpret complex, high-impact multi-dimensional data for commercial QC.
- Advanced mentoring/coaching/influencing/negotiation/personnel interaction.
- Molecular role: expertise in molecular biology methods, including lentiviral, AAV vectors, and gene delivery platforms.
- Travel as needed.
- Bachelor’s/Master’s in bioanalytical science preferred (advanced degree preferred).
- 10+ years relevant experience in regulated cellular therapy or gene therapy (or equivalent).
- Expert knowledge of bioanalytical/molecular techniques (cell-based assays, ELISA, qPCR, flow cytometry) and bioanalytical method lifecycle (characterization, validation, transfer); experience training on 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 biological products.
Benefits
Health coverage (medical, pharmacy, dental, vision); wellbeing support; financial protection (401(k), disability, life/accident insurance, supplemental health, travel protection, personal liability, identity theft, legal support, survivor support).
Work-life Benefits
Paid time off: US exempt flexible time off (unlimited with manager approval) + 11 paid national holidays; or Phoenix/Puerto Rico/Rayzebio exempt/non-exempt/hourly: 160 hours annual vacation + 11 holidays + 3 optional holidays. Additional time off may include sick time, volunteer days, leaves of absence, and Global Shutdown (eligibility-based).
Application Instructions
If your resume does not perfectly align, apply anyway.
The Principal Scientist is responsible for leading method optimization, transfer, and validation in support of the Cell Therapy analytical portfolio. Leads complex projects; provides strategic scientific/technical input; independently troubleshoots non-routine issues using technical, regulatory, and scientific principles. Balances hands-on lab work with cross-functional leadership, mentoring, and external scientific engagement.
Duties/Responsibilities
- Subject matter expert in Cell/Molecular Biology; leads method investigations, optimization/remediations, transfer, and validation per regulatory requirements.
- Independently develop, write, and execute methods, protocols, reports, and related documents aligned with regulatory/corporate guidelines.
- Conceptualize and lead complex projects/investigations/corrective actions/continuous improvement; design and execute experiments; evaluate data; identify risks and impact.
- Represent department in product review boards and regulatory inspections; author analytical sections of regulatory submissions and responses to health authority questions.
- Implement method lifecycle and maintenance programs for viral vector and cell therapy drug products.
- Partner with development organizations on studies/qualification, reagent selection/characterization, and method optimization.
- Represent ASAT on cross-functional/cross-site teams; communicate and collaborate effectively.
Qualifications
- Advanced technical writing.
- Advanced strategic thinking/problem-solving; technically logical.
- Ability to work independently in a fast-paced matrix; meet deadlines; prioritize multiple projects; track record of scientific productivity (publications/presentations/internal contributions).
- Strong communication/collaboration with peers, senior management, and cross-functional teams (local/global).
- Strong hands-on lab skills; execute and interpret complex, high-impact multi-dimensional data for commercial QC.
- Advanced mentoring/coaching/influencing/negotiation/personnel interaction.
- Molecular role: expertise in molecular biology methods, including lentiviral, AAV vectors, and gene delivery platforms.
- Travel as needed.
- Bachelor’s/Master’s in bioanalytical science preferred (advanced degree preferred).
- 10+ years relevant experience in regulated cellular therapy or gene therapy (or equivalent).
- Expert knowledge of bioanalytical/molecular techniques (cell-based assays, ELISA, qPCR, flow cytometry) and bioanalytical method lifecycle (characterization, validation, transfer); experience training on 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 biological products.
Benefits
Health coverage (medical, pharmacy, dental, vision); wellbeing support; financial protection (401(k), disability, life/accident insurance, supplemental health, travel protection, personal liability, identity theft, legal support, survivor support).
Work-life Benefits
Paid time off: US exempt flexible time off (unlimited with manager approval) + 11 paid national holidays; or Phoenix/Puerto Rico/Rayzebio exempt/non-exempt/hourly: 160 hours annual vacation + 11 holidays + 3 optional holidays. Additional time off may include sick time, volunteer days, leaves of absence, and Global Shutdown (eligibility-based).
Application Instructions
If your resume does not perfectly align, apply anyway.