Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy
Bristol Myers Squibb
6 hours ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Duties/Responsibilities:
- Provide viral vector analytical expertise supporting QC lab investigations (technical investigations, root cause, CAPA, method remediations).
- Support transfer of commercial analytical methods and perform method validation per global regulatory requirements.
- Steward viral vector analytical methods within Cell Therapy Quality.
- Implement method lifecycle and maintenance programs for viral vector drug substance analytical methods.
- Author/revise/review technical documents (test methods, SOPs, trend reports, investigation reports).
- Lead project work, CAPA, and deviation/investigation tasks and/or continuous improvement.
- Support regulatory submissions’ analytical sections; respond to health authority questions; serve as method validation/transfer expert during inspections.
- Partner on development/qualification studies design, reagent selection/characterization, and method optimization; represent function on cross-functional teams.
- Train and mentor others; foster a collaborative quality culture.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline (advanced degree preferred).
- 8+ years of relevant analytical experience (GMP/regulatory preferred), ideally in cellular therapy or gene therapy.
- Advanced experience with lentiviral/AAV and other gene delivery analytical methodologies.
- Experience with analytical method lifecycle (transfer, validation, maintenance) and training in method execution/instrument operation/standardization.
- cGMP Quality Control experience.
- Strong knowledge of FDA, EMA, ICH, USP, and EP guidelines for viral vectors/cell therapies/vaccines/biologics.
- Strong time management, initiative, flexibility (independent and team work).
- Strong technical writing (SOPs, Method Validation Protocols/Reports).
- Effective communication with cross-functional teams.
- Ability to travel to BMS/partner sites.
Benefits (as listed): Health, wellbeing programs, 401(k) and insurance/disability; Paid Time Off; flexible time off (role/location dependent); paid vacation/holidays (role/location dependent); Global Shutdown; summer hours (US office-based, eligibility-dependent).
- Provide viral vector analytical expertise supporting QC lab investigations (technical investigations, root cause, CAPA, method remediations).
- Support transfer of commercial analytical methods and perform method validation per global regulatory requirements.
- Steward viral vector analytical methods within Cell Therapy Quality.
- Implement method lifecycle and maintenance programs for viral vector drug substance analytical methods.
- Author/revise/review technical documents (test methods, SOPs, trend reports, investigation reports).
- Lead project work, CAPA, and deviation/investigation tasks and/or continuous improvement.
- Support regulatory submissions’ analytical sections; respond to health authority questions; serve as method validation/transfer expert during inspections.
- Partner on development/qualification studies design, reagent selection/characterization, and method optimization; represent function on cross-functional teams.
- Train and mentor others; foster a collaborative quality culture.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline (advanced degree preferred).
- 8+ years of relevant analytical experience (GMP/regulatory preferred), ideally in cellular therapy or gene therapy.
- Advanced experience with lentiviral/AAV and other gene delivery analytical methodologies.
- Experience with analytical method lifecycle (transfer, validation, maintenance) and training in method execution/instrument operation/standardization.
- cGMP Quality Control experience.
- Strong knowledge of FDA, EMA, ICH, USP, and EP guidelines for viral vectors/cell therapies/vaccines/biologics.
- Strong time management, initiative, flexibility (independent and team work).
- Strong technical writing (SOPs, Method Validation Protocols/Reports).
- Effective communication with cross-functional teams.
- Ability to travel to BMS/partner sites.
Benefits (as listed): Health, wellbeing programs, 401(k) and insurance/disability; Paid Time Off; flexible time off (role/location dependent); paid vacation/holidays (role/location dependent); Global Shutdown; summer hours (US office-based, eligibility-dependent).