Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy
Bristol Myers Squibb, Seattle, WA, United States
Senior Scientist, Vector Analytical Science And Technology (ASAT), Cell Therapy
Location:
Devens, MA
Requisition Number:
R1601165
Position Summary
Function as an analytical expert supporting the Cellular Therapy product portfolio. Successful candidates will have a strong foundation in development of analytical methods supporting the release of viral vectors as well as 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 participating in technical investigations, identifying root cause, and providing corrective and preventive actions, including method remediations.
Support transfer of commercial analytical methods and method validation in compliance with global regulatory requirements.
Responsible for the stewardship of viral vector analytical methods in the Cell Therapy Quality organization.
Implement method lifecycle and maintenance programs to support analytical methods in support of viral vector drug substances.
Author, revise, and review technical documents such as test methods, SOPs, trend reports, and investigation reports.
Lead project, CAPA, deviation, investigation‑related tasks and continuous improvement efforts.
Support authoring of the analytical sections of regulatory submissions and respond to health authority questions, functioning as method validation and transfer expert during inspections.
Partner with development organizations in design of studies, selection of reagents, and method optimization, representing the function on cross‑functional project teams.
Train and mentor others on analytical techniques, methods, and procedures.
Champion and foster a positive and collaborative quality culture.
Perform other tasks as assigned.
Qualifications
Bachelor’s degree in a relevant scientific discipline or equivalent is required; advanced degree preferred.
8+ years of relevant analytical experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy.
Advanced experience with analytical methodologies related to lentiviral, AAV vectors, and other gene delivery platforms.
Experience in analytical method lifecycle including transfer, validation and maintenance, and in providing training in method execution, instrument operation and standardization.
Experience in cGMP regulations and application within the Quality Control environment.
Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations related to the quality control of viral vectors, cell therapies, vaccines and/or biological products.
Effective time‑management skills and ability to work independently and as part of a team.
Strong technical writing experience (SOPs, Method Validation Protocols and Reports).
Excellent communication skills with peers, management and cross‑functional teams.
Ability to travel to other BMS sites or partner sites is required.
Compensation Overview
Devens, MA – $115,790 – $140,307
Madison, Giralda, NJ – $108,210 – $131,129
Seattle, WA – $119,030 – $144,241
The starting compensation range listed above is for a full‑time employee. Additional incentive cash and stock opportunities may be available based on eligibility.
Benefits
Health Coverage:
Medical, pharmacy, dental and vision care.
Well‑being Support:
BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs.
Financial Well‑being and Protection:
401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance and more.
Equal Opportunity Employer
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Location:
Devens, MA
Requisition Number:
R1601165
Position Summary
Function as an analytical expert supporting the Cellular Therapy product portfolio. Successful candidates will have a strong foundation in development of analytical methods supporting the release of viral vectors as well as 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 participating in technical investigations, identifying root cause, and providing corrective and preventive actions, including method remediations.
Support transfer of commercial analytical methods and method validation in compliance with global regulatory requirements.
Responsible for the stewardship of viral vector analytical methods in the Cell Therapy Quality organization.
Implement method lifecycle and maintenance programs to support analytical methods in support of viral vector drug substances.
Author, revise, and review technical documents such as test methods, SOPs, trend reports, and investigation reports.
Lead project, CAPA, deviation, investigation‑related tasks and continuous improvement efforts.
Support authoring of the analytical sections of regulatory submissions and respond to health authority questions, functioning as method validation and transfer expert during inspections.
Partner with development organizations in design of studies, selection of reagents, and method optimization, representing the function on cross‑functional project teams.
Train and mentor others on analytical techniques, methods, and procedures.
Champion and foster a positive and collaborative quality culture.
Perform other tasks as assigned.
Qualifications
Bachelor’s degree in a relevant scientific discipline or equivalent is required; advanced degree preferred.
8+ years of relevant analytical experience or equivalent combination of education and experience, preferably in a regulated environment (GMP), cellular therapy, or gene therapy.
Advanced experience with analytical methodologies related to lentiviral, AAV vectors, and other gene delivery platforms.
Experience in analytical method lifecycle including transfer, validation and maintenance, and in providing training in method execution, instrument operation and standardization.
Experience in cGMP regulations and application within the Quality Control environment.
Strong understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations related to the quality control of viral vectors, cell therapies, vaccines and/or biological products.
Effective time‑management skills and ability to work independently and as part of a team.
Strong technical writing experience (SOPs, Method Validation Protocols and Reports).
Excellent communication skills with peers, management and cross‑functional teams.
Ability to travel to other BMS sites or partner sites is required.
Compensation Overview
Devens, MA – $115,790 – $140,307
Madison, Giralda, NJ – $108,210 – $131,129
Seattle, WA – $119,030 – $144,241
The starting compensation range listed above is for a full‑time employee. Additional incentive cash and stock opportunities may be available based on eligibility.
Benefits
Health Coverage:
Medical, pharmacy, dental and vision care.
Well‑being Support:
BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs.
Financial Well‑being and Protection:
401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance and more.
Equal Opportunity Employer
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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