Senior Specialist, QC Analytical
About The Position
The Senior Specialist position is responsible for performing routine testing of in-process, final product, and stability samples in accordance with BMS policies, standards, procedures, and Global Regulatory and cGMP requirements to support the Quality Control Analytical department in the Bristol Myers Squibb (BMS) CAR T Manufacturing facility located in Summit, NJ. Additionally, this role performs data review for general and complex methods to support final drug product release. This position requires high problem-solving skills/mentality with minimal guidance, the ability to interface with multiple cross functional groups, as well as the ability to work in a fast-paced team environment.
Requirements
- Demonstrated experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
- Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- Demonstrated technical writing skills.
- High problem-solving ability/mentality, technically adept and logical.
- Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
- Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Bachelor’s degree or equivalent required, preferably in Science.
- 4+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
- Demonstrated experience in cell and molecular biology techniques (e.g., cell based assays, flow cytometry, qPCR, ELISA, and aseptic technique).
Nice To Haves
- Advanced degree preferred.
- Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
Responsibilities
- Perform method transfer/validation and routine testing of in-process, final product, and stability samples.
- Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
- Perform data verification, data review and review of GMP documentation for general and complex methods.
- Perform document revision, project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- Train and mentor others on QC test methods, processes, and procedures.
- Perform other tasks as assigned.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually for new hires
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
