Senior Principal Scientist, Drug Product Analytical Science and Technology (ASAT), Cell Therapy
Bristol Myers Squibb
6 days ago
Remote friendly (Seattle, WA)
United States
Clinical Research and Development
Position Summary:
Senior Principal Scientist (Drug Product Analytical Science and Technology, ASAT) for Cell Therapy. Technical leadership role and subject matter expert in molecular biology analytical methods; leads design, execution, and interpretation of complex scientific programs. Manages a team for method optimization, transfer, and validation to support the Cell Therapy analytical portfolio.
Duties/Responsibilities:
- Lead and manage team for molecular biology method investigation, optimization/remediations, transfer, and validation in compliance with regulatory requirements.
- Perform/direct hands-on lab work supporting commercial QC analytical method investigation, remediation, and/or optimization.
- Critically evaluate data; identify risks/opportunities; recommend course corrections and integrate findings to advance program hypotheses.
- Act as SME as needed.
- Make high-impact scientific/strategic decisions under uncertainty; balance ambition with risk management.
- Represent department in product review boards and regulatory inspections/audits; author/own relevant analytical sections of regulatory submissions and responses.
- 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 effectively.
- Troubleshoot and solve non-routine complex issues.
- Hire, mentor, and develop ASAT personnel.
Qualifications:
- Strong molecular biology expertise (lentiviral, AAV vectors, other gene delivery platforms).
- Advanced technical writing.
- Advanced strategic thinking/problem-solving; logical, technically adept.
- Ability to work independently in a fast-paced matrix; prioritize multiple projects.
- Advanced communication/collaboration globally.
- Expertise executing/interpreting complex multi-dimensional data for commercial QC methods.
- Formal reports and technical presentations for investigations and regulatory submissions.
- Biopharmaceutical industry leadership track record; translate complex science for diverse audiences.
- Advanced mentoring/coaching/influencing/negotiation skills.
- Travel as needed.
Education/Experience:
- Bachelor’s/Master’s in bioanalytical science (Master’s preferred).
- 10+ years’ relevant experience in regulated cellular or gene therapy.
- Knowledge of cGMP; FDA/EMA/ICH/USP/EP guidelines for QC of viral vectors/cell therapies/vaccines/biological products. Bioanalytical techniques (cell-based assays, ELISA, flow cytometry) and method lifecycle/standardization experience preferred.
Compensation/Benefits (if applicable):
- Seattle, WA: $152,820–$185,184.
- Benefits include health coverage, wellbeing support, 401(k), disability/life insurance, and PTO (flexible time off for US exempt employees; 160 hours annual vacation for certain exempt/non-exempt hourly roles).
Application instructions:
- If the role doesn’t perfectly match your resume, apply anyway.
Senior Principal Scientist (Drug Product Analytical Science and Technology, ASAT) for Cell Therapy. Technical leadership role and subject matter expert in molecular biology analytical methods; leads design, execution, and interpretation of complex scientific programs. Manages a team for method optimization, transfer, and validation to support the Cell Therapy analytical portfolio.
Duties/Responsibilities:
- Lead and manage team for molecular biology method investigation, optimization/remediations, transfer, and validation in compliance with regulatory requirements.
- Perform/direct hands-on lab work supporting commercial QC analytical method investigation, remediation, and/or optimization.
- Critically evaluate data; identify risks/opportunities; recommend course corrections and integrate findings to advance program hypotheses.
- Act as SME as needed.
- Make high-impact scientific/strategic decisions under uncertainty; balance ambition with risk management.
- Represent department in product review boards and regulatory inspections/audits; author/own relevant analytical sections of regulatory submissions and responses.
- 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 effectively.
- Troubleshoot and solve non-routine complex issues.
- Hire, mentor, and develop ASAT personnel.
Qualifications:
- Strong molecular biology expertise (lentiviral, AAV vectors, other gene delivery platforms).
- Advanced technical writing.
- Advanced strategic thinking/problem-solving; logical, technically adept.
- Ability to work independently in a fast-paced matrix; prioritize multiple projects.
- Advanced communication/collaboration globally.
- Expertise executing/interpreting complex multi-dimensional data for commercial QC methods.
- Formal reports and technical presentations for investigations and regulatory submissions.
- Biopharmaceutical industry leadership track record; translate complex science for diverse audiences.
- Advanced mentoring/coaching/influencing/negotiation skills.
- Travel as needed.
Education/Experience:
- Bachelor’s/Master’s in bioanalytical science (Master’s preferred).
- 10+ years’ relevant experience in regulated cellular or gene therapy.
- Knowledge of cGMP; FDA/EMA/ICH/USP/EP guidelines for QC of viral vectors/cell therapies/vaccines/biological products. Bioanalytical techniques (cell-based assays, ELISA, flow cytometry) and method lifecycle/standardization experience preferred.
Compensation/Benefits (if applicable):
- Seattle, WA: $152,820–$185,184.
- Benefits include health coverage, wellbeing support, 401(k), disability/life insurance, and PTO (flexible time off for US exempt employees; 160 hours annual vacation for certain exempt/non-exempt hourly roles).
Application instructions:
- If the role doesn’t perfectly match your resume, apply anyway.