Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations
About The Position
Bristol Myers Squibb is reimagining the future of cell therapy and is looking for a Manufacturing Associate to join their Cell Therapy team. This role will manufacture human blood-derived components per Batch Record and Standard Operating Procedures in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Manufacturing Associates adhere to regulatory requirements while performing job functions. Job duties are performed within a team according to an assigned production shift schedule. Communication of production deviations and assistance with quality investigations are required, as applicable. The available shift is Wednesday-Saturday (with every other Wednesday off), Onsite Day Shift, 5 p.m. - 5:30 a.m. Start and end times are subject to change based on business demands.
Requirements
- Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique.
- Knowledge of cGMP/FDA regulated industry.
- Basic mathematical skills.
- General understanding of cGMPs.
- Technical writing capability.
- Proficient in MS Office applications.
- Background to include an understanding of biology, chemistry, medical or clinical practices
- High School Diploma required.
- 0-1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.
Nice To Haves
- Bachelor's or associate degree preferred.
Responsibilities
- Perform set-up and operation of equipment to support production of blood component lots through cell culture, harvest, and cryopreservation.
- Support deviation investigations and write ups as needed. Support on time closure of any assigned CAPAs within the designated shift.
- Aseptic technique is required for tube most activities: welding, connections, and transfers, at minimum. Aseptic qualification is required.
- Weighs and measures in-process materials to ensure proper quantities are added/removed.
- Adheres to the production schedule ensuring on-time, internal production logistics.
- Records production data and information in a clear, concise, format according to proper GDPs.
- Perform all tasks in a manner consistent with site safety policies, quality systems, and GMP requirements.
- Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
- Motivated, team consciousness individuals are needed to fulfill job requirements.
- Become a SME and qualified trainer within a designated function of manufacturing. Supervision will be managed by the shift Supervisor or designated Team Lead.
- Maintain on time completion of training assignments to maintain the necessary technical skills and process knowledge.
- Performs other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.
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.
- Paid Time Off
- flexible time off (unlimited, with manager approval, 11 paid national holidays)
- 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- 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
- annual Global Shutdown between Christmas and New Years Day.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
