Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy
Bristol Myers Squibb
5 hours ago
Remote friendly (Madison, NJ)
United States
Clinical Research and Development
Position Summary
- Function as an analytical expert supporting the Cellular Therapy product portfolio, with a foundation in development of analytical methods for viral vector release and transfer, validation, and life-cycle management of test methods in a cGMP environment.
Duties/Responsibilities
- Provide viral vector analytical expertise in support of QC lab investigations, including technical investigations, root cause identification, corrective/preventive actions, and method remediations.
- Support transfer of commercial analytical methods and method validation per global regulatory requirements.
- Stewardship of viral vector analytical methods in the Cell Therapy Quality organization.
- Implement method lifecycle and method maintenance programs for analytical methods supporting viral vector drug substances.
- Author, revise, and review technical documents (test methods, SOPs, trend reports, investigation reports).
- Lead project work, CAPA, and deviation/investigation tasks and/or continuous improvement efforts.
- Support analytical sections of regulatory submissions; respond to health authority questions; serve as method validation and method transfer expert during inspections.
- Partner with development organizations on development/qualification study design, reagent selection/characterization, and method optimization; represent function on cross-functional teams.
- Train and mentor others on analytical techniques, methods, and procedures.
- Champion and foster a positive, collaborative quality culture.
- Perform other tasks as assigned.
Qualifications
- Bachelor’s degree in a relevant scientific discipline or equivalent required; advanced degree preferred.
- 8+ years of relevant analytical experience (or equivalent combination), preferably in GMP/regulatory environment, cellular therapy, or gene therapy.
- Advanced experience with analytical methodologies including lentiviral, AAV vectors, and other gene delivery platforms.
- Experience with analytical method lifecycle (transfer, validation, maintenance), including training in method execution, instrument operation, and standardization.
- Experience applying cGMP regulations within a Quality Control environment.
- Strong understanding of FDA, EMA, ICH, USP, and EP guidelines for quality control of viral vectors, cell therapies, vaccines, and/or biological products.
- Effective time management; initiative, resourcefulness, flexibility; ability to work independently and in a team.
- Strong technical writing experience (SOPs, Method Validation Protocols and Reports).
- Ability to communicate effectively with peers, management, and cross-functional partners.
- Ability to travel to other BMS or partner sites required.
- Function as an analytical expert supporting the Cellular Therapy product portfolio, with a foundation in development of analytical methods for viral vector release and transfer, validation, and life-cycle management of test methods in a cGMP environment.
Duties/Responsibilities
- Provide viral vector analytical expertise in support of QC lab investigations, including technical investigations, root cause identification, corrective/preventive actions, and method remediations.
- Support transfer of commercial analytical methods and method validation per global regulatory requirements.
- Stewardship of viral vector analytical methods in the Cell Therapy Quality organization.
- Implement method lifecycle and method maintenance programs for analytical methods supporting viral vector drug substances.
- Author, revise, and review technical documents (test methods, SOPs, trend reports, investigation reports).
- Lead project work, CAPA, and deviation/investigation tasks and/or continuous improvement efforts.
- Support analytical sections of regulatory submissions; respond to health authority questions; serve as method validation and method transfer expert during inspections.
- Partner with development organizations on development/qualification study design, reagent selection/characterization, and method optimization; represent function on cross-functional teams.
- Train and mentor others on analytical techniques, methods, and procedures.
- Champion and foster a positive, collaborative quality culture.
- Perform other tasks as assigned.
Qualifications
- Bachelor’s degree in a relevant scientific discipline or equivalent required; advanced degree preferred.
- 8+ years of relevant analytical experience (or equivalent combination), preferably in GMP/regulatory environment, cellular therapy, or gene therapy.
- Advanced experience with analytical methodologies including lentiviral, AAV vectors, and other gene delivery platforms.
- Experience with analytical method lifecycle (transfer, validation, maintenance), including training in method execution, instrument operation, and standardization.
- Experience applying cGMP regulations within a Quality Control environment.
- Strong understanding of FDA, EMA, ICH, USP, and EP guidelines for quality control of viral vectors, cell therapies, vaccines, and/or biological products.
- Effective time management; initiative, resourcefulness, flexibility; ability to work independently and in a team.
- Strong technical writing experience (SOPs, Method Validation Protocols and Reports).
- Ability to communicate effectively with peers, management, and cross-functional partners.
- Ability to travel to other BMS or partner sites required.