Principal Scientist, Analytical Science and Technology (ASAT), Cell Therapy
Bristol Myers Squibb
16 days ago
Remote friendly (Devens, MA)
United States
Clinical Research and Development
Position Summary
- Principal Scientist (Cell Therapy, Analytical Science and Technology) leading method optimization, transfer, and validation for the Cell Therapy analytical portfolio.
Duties/Responsibilities
- Lead method technical investigations, optimization/remediations, transfer, and validation for compliance with regulatory requirements.
- Independently develop, write, and execute methods/protocols/reports aligned with regulatory and corporate guidelines.
- Conceptualize and lead complex projects, investigations, corrective actions, and continuous improvement (design/execute experiments, evaluate data, identify risks/impact).
- Represent the department in product review boards and regulatory inspections; author analytical sections of regulatory submissions and responses.
- Implement method lifecycle and maintenance programs for viral vector and cell therapy drug products.
- Partner on development/qualification studies; select/characterize reagents; drive method optimization.
- Represent ASAT across cross-functional/cross-site teams; communicate effectively.
- Troubleshoot and solve non-routine complex issues; perform other tasks as assigned.
Qualifications (Required/Preferred)
- Advanced technical writing skills.
- Strong strategic problem-solving; ability to work independently in a fast-paced matrix environment and prioritize multiple projects.
- Advanced communication/collaboration with peers and senior management (local/global).
- Strong hands-on lab experience interpreting complex multidimensional data for commercial QC analytical methods.
- Advanced mentoring/coaching/influencing and personnel interaction skills.
- Strong background with analytical methodologies for lentiviral/AAV vectors and gene delivery platforms.
- Ability to travel as needed.
- BS/MS in (bioanalytical) science preferred; advanced degree preferred.
- 10+ years’ regulated cellular therapy or gene therapy experience.
- Expertise in bioanalytical methods lifecycle (cell-based assays, ELISA, qPCR, flow cytometry).
- cGMP and Quality Control experience; knowledge of FDA/EMA/ICH/USP/EP guidelines.
Benefits (if eligible)
- Health coverage; wellbeing programs (including EAP); 401(k), disability/life insurance.
- Paid time off (flexible time off or vacation, plus national holidays).
Application Instructions
- If the role interests you but your resume doesn’t perfectly match, you are encouraged to apply anyway.
- Principal Scientist (Cell Therapy, Analytical Science and Technology) leading method optimization, transfer, and validation for the Cell Therapy analytical portfolio.
Duties/Responsibilities
- Lead method technical investigations, optimization/remediations, transfer, and validation for compliance with regulatory requirements.
- Independently develop, write, and execute methods/protocols/reports aligned with regulatory and corporate guidelines.
- Conceptualize and lead complex projects, investigations, corrective actions, and continuous improvement (design/execute experiments, evaluate data, identify risks/impact).
- Represent the department in product review boards and regulatory inspections; author analytical sections of regulatory submissions and responses.
- Implement method lifecycle and maintenance programs for viral vector and cell therapy drug products.
- Partner on development/qualification studies; select/characterize reagents; drive method optimization.
- Represent ASAT across cross-functional/cross-site teams; communicate effectively.
- Troubleshoot and solve non-routine complex issues; perform other tasks as assigned.
Qualifications (Required/Preferred)
- Advanced technical writing skills.
- Strong strategic problem-solving; ability to work independently in a fast-paced matrix environment and prioritize multiple projects.
- Advanced communication/collaboration with peers and senior management (local/global).
- Strong hands-on lab experience interpreting complex multidimensional data for commercial QC analytical methods.
- Advanced mentoring/coaching/influencing and personnel interaction skills.
- Strong background with analytical methodologies for lentiviral/AAV vectors and gene delivery platforms.
- Ability to travel as needed.
- BS/MS in (bioanalytical) science preferred; advanced degree preferred.
- 10+ years’ regulated cellular therapy or gene therapy experience.
- Expertise in bioanalytical methods lifecycle (cell-based assays, ELISA, qPCR, flow cytometry).
- cGMP and Quality Control experience; knowledge of FDA/EMA/ICH/USP/EP guidelines.
Benefits (if eligible)
- Health coverage; wellbeing programs (including EAP); 401(k), disability/life insurance.
- Paid time off (flexible time off or vacation, plus national holidays).
Application Instructions
- If the role interests you but your resume doesn’t perfectly match, you are encouraged to apply anyway.