Senior Specialist QC Microbiology Cell Therapy

Bristol Myers Squibb•Summit, NJ

1d•Hybrid

About The Position

Bristol Myers Squibb is seeking a Senior Specialist QC Microbiology Cell Therapy to support QC testing for in-process, final product, and stability samples. This role also involves supporting environmental and facility monitoring, including data review and verification. The specialist will perform method troubleshooting, training, and transfer/validation. Additionally, they will execute document revisions, manage projects, handle deviations/investigations/CAPA, and contribute to continuous improvement efforts. Bristol Myers Squibb offers a work environment that values balance and flexibility, with a wide variety of competitive benefits and programs designed to support employees' goals both professionally and personally.

Requirements

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.
4+ years of relevant microbiological testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.
Demonstrated experience with microbiological techniques.

Nice To Haves

Advanced knowledge of LIMS, ELN and laboratory data analysis systems preferred.
Bachelor's degree or equivalent required, preferably in science.
Advanced degree preferred.
Netherlands: MLO level 4 required.

Responsibilities

Perform method transfer/verification/validation, routine testing of in-process, final product, and stability samples.
Perform environmental/facilities monitoring and microbiological testing.
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

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
Flexible time off (unlimited, with manager approval) for US Exempt Employees.
11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
Unlimited paid sick time (based on eligibility).
Up to 2 paid volunteer days per year (based on eligibility).
Summer hours flexibility (based on eligibility).
Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
Annual Global Shutdown between Christmas and New Years Day.