Principal Scientist, QC Analytical, Cell Therapy
Bristol Myers Squibb
6 days ago
Remote friendly (Devens, MA)
United States
Operations
Work Schedule
- Monday through Friday with weekend/holiday support if required but not routinely expected
Duties and Responsibilities
- Subject matter expert in bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry), leading method transfer/validation and routine testing of in-process, final product, and stability samples
- Train and mentor team on complex QC test methods, processes, and procedures
- Independently develop, write, and execute methods/protocols/reports aligned with regulatory and corporate guidelines; represent the department in product review boards and regulatory inspections
- Own and author responses to regulatory requests
- Review and approve laboratory investigations
- Lead CAPAs, deviations, and continuous improvement; champion a collaborative quality culture
- Own sections of APQR and represent QC on cross-functional/cross-site teams
- Troubleshoot and problem-solve nonroutine complex issues; perform other tasks as assigned
Education and Experience
- Bachelor’s degree or equivalent required (preferably science); advanced degree preferred (Netherlands: PhD in bioanalytical science preferred)
- 10+ years relevant analytical testing experience, including 2+ years QC experience
- Expert bioanalytical knowledge and deep expertise in characterization/validation/transfer of bioanalytical methods
Required Knowledge and Skills
- Advanced understanding of global regulatory and cGMP requirements
- Advanced technical writing skills
- Advanced strategic thinking and problem-solving
- Ability to work independently, meet deadlines, and prioritize multiple projects
- Effective cross-functional communication and collaboration (locally and globally)
- Advanced mentoring/coaching/influencing skills
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision)
- Wellbeing support; Employee Assistance Programs
- 401(k), short- and long-term disability, life and accident insurance, supplemental health, business travel protection, and related protection/support
Compensation Overview (explicit)
- Devens, MA (US): $124,590–$150,977
Application Instruction
- If the role doesn’t perfectly match your resume, you are encouraged to apply anyway.
- Monday through Friday with weekend/holiday support if required but not routinely expected
Duties and Responsibilities
- Subject matter expert in bioanalytical techniques (cell-based assays, ELISA, qPCR, flow cytometry), leading method transfer/validation and routine testing of in-process, final product, and stability samples
- Train and mentor team on complex QC test methods, processes, and procedures
- Independently develop, write, and execute methods/protocols/reports aligned with regulatory and corporate guidelines; represent the department in product review boards and regulatory inspections
- Own and author responses to regulatory requests
- Review and approve laboratory investigations
- Lead CAPAs, deviations, and continuous improvement; champion a collaborative quality culture
- Own sections of APQR and represent QC on cross-functional/cross-site teams
- Troubleshoot and problem-solve nonroutine complex issues; perform other tasks as assigned
Education and Experience
- Bachelor’s degree or equivalent required (preferably science); advanced degree preferred (Netherlands: PhD in bioanalytical science preferred)
- 10+ years relevant analytical testing experience, including 2+ years QC experience
- Expert bioanalytical knowledge and deep expertise in characterization/validation/transfer of bioanalytical methods
Required Knowledge and Skills
- Advanced understanding of global regulatory and cGMP requirements
- Advanced technical writing skills
- Advanced strategic thinking and problem-solving
- Ability to work independently, meet deadlines, and prioritize multiple projects
- Effective cross-functional communication and collaboration (locally and globally)
- Advanced mentoring/coaching/influencing skills
Benefits (explicitly listed)
- Health coverage (medical, pharmacy, dental, vision)
- Wellbeing support; Employee Assistance Programs
- 401(k), short- and long-term disability, life and accident insurance, supplemental health, business travel protection, and related protection/support
Compensation Overview (explicit)
- Devens, MA (US): $124,590–$150,977
Application Instruction
- If the role doesn’t perfectly match your resume, you are encouraged to apply anyway.