Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy
Bristol Myers Squibb
5 hours ago
Remote friendly (Devens, MA)
United States
Clinical Research and Development
Position Summary
Function as an analytical expert supporting the Cellular Therapy product portfolio, with a strong foundation in development of analytical methods supporting release of viral vectors 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, and corrective/preventive actions with method remediations.
- Support transfer of commercial analytical methods and method validation in compliance with global regulatory requirements.
- Steward viral vector analytical methods in the Cell Therapy Quality organization.
- Implement method lifecycle and method maintenance programs for viral vector drug substance analytical methods.
- Author, revise, and review test methods, SOPs, trend reports, and/or investigation reports as appropriate.
- Lead project work, CAPA, and deviation/investigation tasks and/or continuous improvement efforts.
- Support regulatory submissions’ analytical sections; 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 education/experience), preferably in GMP, cellular therapy, or gene therapy.
- Advanced experience with analytical methodologies for lentiviral, AAV vectors, and other gene delivery platforms.
- Experience with analytical method lifecycle (transfer, validation, maintenance) and training in method execution, instrument operation, and standardization.
- Experience with cGMP regulations in 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, and flexibility working independently and on teams.
- Strong technical writing experience (SOPs, Method Validation Protocols/Reports) required.
- Ability to communicate effectively with peers and cross-functional partners.
- Ability to travel to other BMS sites or Partner sites required.
Compensation/Benefits
- Health Coverage; Wellbeing Support Programs; Financial Well-being and Protection (including 401(k), disability, life insurance, and related benefits).
- Work-life benefits include Paid Time Off (flexible time off and/or vacation details by location/employee type) and potential additional time off based on eligibility, including Global Shutdown (per eligibility).
Application Instructions
- If the role doesn’t perfectly match your resume, encouraged to apply anyway.
Function as an analytical expert supporting the Cellular Therapy product portfolio, with a strong foundation in development of analytical methods supporting release of viral vectors 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, and corrective/preventive actions with method remediations.
- Support transfer of commercial analytical methods and method validation in compliance with global regulatory requirements.
- Steward viral vector analytical methods in the Cell Therapy Quality organization.
- Implement method lifecycle and method maintenance programs for viral vector drug substance analytical methods.
- Author, revise, and review test methods, SOPs, trend reports, and/or investigation reports as appropriate.
- Lead project work, CAPA, and deviation/investigation tasks and/or continuous improvement efforts.
- Support regulatory submissions’ analytical sections; 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 education/experience), preferably in GMP, cellular therapy, or gene therapy.
- Advanced experience with analytical methodologies for lentiviral, AAV vectors, and other gene delivery platforms.
- Experience with analytical method lifecycle (transfer, validation, maintenance) and training in method execution, instrument operation, and standardization.
- Experience with cGMP regulations in 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, and flexibility working independently and on teams.
- Strong technical writing experience (SOPs, Method Validation Protocols/Reports) required.
- Ability to communicate effectively with peers and cross-functional partners.
- Ability to travel to other BMS sites or Partner sites required.
Compensation/Benefits
- Health Coverage; Wellbeing Support Programs; Financial Well-being and Protection (including 401(k), disability, life insurance, and related benefits).
- Work-life benefits include Paid Time Off (flexible time off and/or vacation details by location/employee type) and potential additional time off based on eligibility, including Global Shutdown (per eligibility).
Application Instructions
- If the role doesn’t perfectly match your resume, encouraged to apply anyway.