Senior Scientist, Drug Product Analytical Science (ASAT), Cell Therapy
Bristol Myers Squibb
8 days ago
On-site
Summit, NJ
Clinical Research and Development
Position Summary:
Senior Scientist (technical expert) supporting the Cellular Therapy product portfolio. Designs and executes lab experiments, analyzes data, and interprets results in bioassay, flow cytometry, and/or molecular biology. Performs hands-on laboratory experiments supporting QC analytical methods.
Duties/Responsibilities:
- Provide bioassay/flow cytometry/molecular biology analytical expertise for QC investigations; support root-cause and CAPA, method remediations, and bench studies.
- Independently design, plan, and execute experiments per protocols/objectives; analyze and document data; collaborate cross-functionally; develop/optimize methods and protocols.
- Present findings/progress; support internal technical reports/presentations.
- Support commercial method transfer and method validation per global regulatory requirements.
- Steward bioassay/flow cytometry/molecular methods; implement method lifecycle/maintenance.
- Author/revise/review test methods, SOPs, trend and investigation reports.
- Lead project/CAPA/deviation/investigation and continuous improvement efforts.
- Support analytical sections of regulatory submissions; respond to health authority questions; serve as method validation/transfer expert during inspections.
- Partner on development/qualification studies and reagent selection/characterization; train/mentor others.
Qualifications/Required Skills:
- Bachelor’s in relevant science (advanced degree preferred).
- 8+ years relevant analytical experience (preferably GMP, cellular therapy, or gene therapy).
- Expertise in cell-based bioassays (potency, reporter gene assays, cell counting), flow cytometry (instrument platforms, standardization, multiparameter, antibody titration), and molecular biology (lentiviral/AAV and gene delivery).
- Hands-on lab technique proficiency.
- Analytical method lifecycle: transfer, validation, maintenance; training on method execution and instrument operation/standardization.
- cGMP/QC experience; knowledge of FDA/EMA/ICH/USP/EP guidelines.
- Strong technical writing (SOPs, method validation protocols/reports) and communication.
- Travel to other BMS/partner sites.
Compensation/Benefits (as stated):
Seattle, WA: $117,150–$141,955; Summit West, NJ: $106,500–$129,049. Health, wellbeing, financial protection (incl. 401(k), disability, life insurance) and paid time off (details vary by location).
Application instructions:
If your resume isn’t a perfect match, apply anyway.
Senior Scientist (technical expert) supporting the Cellular Therapy product portfolio. Designs and executes lab experiments, analyzes data, and interprets results in bioassay, flow cytometry, and/or molecular biology. Performs hands-on laboratory experiments supporting QC analytical methods.
Duties/Responsibilities:
- Provide bioassay/flow cytometry/molecular biology analytical expertise for QC investigations; support root-cause and CAPA, method remediations, and bench studies.
- Independently design, plan, and execute experiments per protocols/objectives; analyze and document data; collaborate cross-functionally; develop/optimize methods and protocols.
- Present findings/progress; support internal technical reports/presentations.
- Support commercial method transfer and method validation per global regulatory requirements.
- Steward bioassay/flow cytometry/molecular methods; implement method lifecycle/maintenance.
- Author/revise/review test methods, SOPs, trend and investigation reports.
- Lead project/CAPA/deviation/investigation and continuous improvement efforts.
- Support analytical sections of regulatory submissions; respond to health authority questions; serve as method validation/transfer expert during inspections.
- Partner on development/qualification studies and reagent selection/characterization; train/mentor others.
Qualifications/Required Skills:
- Bachelor’s in relevant science (advanced degree preferred).
- 8+ years relevant analytical experience (preferably GMP, cellular therapy, or gene therapy).
- Expertise in cell-based bioassays (potency, reporter gene assays, cell counting), flow cytometry (instrument platforms, standardization, multiparameter, antibody titration), and molecular biology (lentiviral/AAV and gene delivery).
- Hands-on lab technique proficiency.
- Analytical method lifecycle: transfer, validation, maintenance; training on method execution and instrument operation/standardization.
- cGMP/QC experience; knowledge of FDA/EMA/ICH/USP/EP guidelines.
- Strong technical writing (SOPs, method validation protocols/reports) and communication.
- Travel to other BMS/partner sites.
Compensation/Benefits (as stated):
Seattle, WA: $117,150–$141,955; Summit West, NJ: $106,500–$129,049. Health, wellbeing, financial protection (incl. 401(k), disability, life insurance) and paid time off (details vary by location).
Application instructions:
If your resume isn’t a perfect match, apply anyway.