Senior Scientist, Drug Product Analytical Science (ASAT), Cell Therapy
Bristol Myers Squibb
August 22, 2026
Remote friendly (Seattle, WA)
United States
Clinical Research and Development
Responsibilities:
- Provide bioassay, flow cytometry, and/or molecular biology analytical expertise supporting QC lab investigations, including root-cause analysis, corrective/preventive actions, method remediations, and bench studies.
- Design, plan, and independently execute experiments per protocols; analyze and document data; collaborate cross-functionally to develop/optimize methods and protocols.
- Present findings and support internal technical reports/presentations.
- Support commercial method transfer and method validation per global regulatory requirements.
- Steward bioassay/flow cytometry/molecular methods in Cell Therapy Quality; implement method lifecycle/maintenance programs.
- Author/revise/review test methods, SOPs, trend reports, and investigation reports.
- Lead project work, CAPA, and deviation/investigation and continuous improvement efforts.
- Support regulatory submission analytical sections; respond to health authority questions; act as method validation/transfer expert during inspections as required.
- Partner on development/qualification studies, reagent selection/characterization, and method optimization; represent function on cross-functional teams.
- Train and mentor others on relevant techniques; foster a positive quality culture.
Qualifications:
- Bachelor’s degree in relevant scientific discipline (advanced degree preferred).
- 8+ years relevant analytical experience (regulated/GMP, cellular therapy, or gene therapy preferred).
- Expertise in bioassay (potency, reporter gene assays, cell counting), flow cytometry (platforms, standardization, multiparameter, antibody titration), and molecular biology (lentiviral/AAV and gene delivery methods).
- Hands-on lab experience with standard techniques.
- Analytical method lifecycle experience (transfer, validation, maintenance) and training; cGMP experience.
- Knowledge of FDA/EMA/ICH/USP/EP for QC of viral vectors/cell therapies/vaccines/biological products.
- Strong technical writing (SOPs, validation protocols/reports), communication, time management, and ability to travel.
Benefits (explicitly listed):
- Medical/dental/vision; wellbeing programs; 401(k), disability, life/accident insurance, and other listed financial protections.
Work-life:
- Paid time off options (including flexible/unlimited time off and/or annual vacation depending on location/role).
- Provide bioassay, flow cytometry, and/or molecular biology analytical expertise supporting QC lab investigations, including root-cause analysis, corrective/preventive actions, method remediations, and bench studies.
- Design, plan, and independently execute experiments per protocols; analyze and document data; collaborate cross-functionally to develop/optimize methods and protocols.
- Present findings and support internal technical reports/presentations.
- Support commercial method transfer and method validation per global regulatory requirements.
- Steward bioassay/flow cytometry/molecular methods in Cell Therapy Quality; implement method lifecycle/maintenance programs.
- Author/revise/review test methods, SOPs, trend reports, and investigation reports.
- Lead project work, CAPA, and deviation/investigation and continuous improvement efforts.
- Support regulatory submission analytical sections; respond to health authority questions; act as method validation/transfer expert during inspections as required.
- Partner on development/qualification studies, reagent selection/characterization, and method optimization; represent function on cross-functional teams.
- Train and mentor others on relevant techniques; foster a positive quality culture.
Qualifications:
- Bachelor’s degree in relevant scientific discipline (advanced degree preferred).
- 8+ years relevant analytical experience (regulated/GMP, cellular therapy, or gene therapy preferred).
- Expertise in bioassay (potency, reporter gene assays, cell counting), flow cytometry (platforms, standardization, multiparameter, antibody titration), and molecular biology (lentiviral/AAV and gene delivery methods).
- Hands-on lab experience with standard techniques.
- Analytical method lifecycle experience (transfer, validation, maintenance) and training; cGMP experience.
- Knowledge of FDA/EMA/ICH/USP/EP for QC of viral vectors/cell therapies/vaccines/biological products.
- Strong technical writing (SOPs, validation protocols/reports), communication, time management, and ability to travel.
Benefits (explicitly listed):
- Medical/dental/vision; wellbeing programs; 401(k), disability, life/accident insurance, and other listed financial protections.
Work-life:
- Paid time off options (including flexible/unlimited time off and/or annual vacation depending on location/role).