Senior Scientist, Vector Analytical Science and Technology, Cell Therapy
Bristol Myers Squibb
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts • New Jersey • United States
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Salary
💰 $115,790 - $144,241 per year
Job Level
About the role
- Function as an analytical expert supporting the Cellular Therapy product portfolio.
- Provide viral vector analytical expertise in support of QC lab 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 method 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/or investigation reports as appropriate.
- Lead project, CAPA and deviation/investigation related tasks and/or continuous improvement efforts.
- Provide support in the authoring of the analytical sections of regulatory submissions and responding to health authority questions.
- Partner with development organizations in the design of development and qualification studies, method optimization initiatives, and represent the function on cross-functional project teams.
- Train and mentor others on analytical techniques, methods and procedures.
- Perform other tasks as assigned.
Requirements
- Bachelor’s degree in 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 various analytical methodologies including those related to lentiviral, AAV vectors and other gene delivery platforms.
- Experience in analytical method lifecycle, including method transfer, validation, and maintenance.
- Experience providing training in method execution as well as 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 associated with the quality control of viral vectors, cell therapies, vaccines and/or biological products.
- Strong technical writing experience (SOPs, Method Validation Protocols and Reports) is required.
- Advance ability to communicate effectively with peers, department management, cross-functional peers.
- Ability to travel to other BMS sites or Partner sites is required.
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Work-life benefits: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays.
- Additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical expertiseviral vector analytical methodsmethod validationmethod transfermethod maintenanceanalytical methodologiescGMP regulationstechnical writingmethod executioninstrument operation
Soft Skills
analytical thinkingcommunicationtrainingmentoringproject leadershipcollaborationproblem-solvingcontinuous improvementattention to detailorganizational skills