Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

Bristol Myers SquibbSummit, NJ
Onsite

About The Position

Bristol Myers Squibb is reimagining the future of cell therapy and is seeking 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 Overnight Shift, 5 p.m. - 5:30 a.m. Start and end times are subject to change based on business demands.

Requirements

  • High School Diploma required.
  • Aseptic qualification is required.
  • 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.
  • 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.
  • Perform aseptic technique for tube welding, connections, and transfers.
  • Weigh and measure in-process materials to ensure proper quantities are added/removed.
  • Adhere to the production schedule ensuring on-time, internal production logistics.
  • Record 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.
  • Work in a team-based, cross-functional environment to complete production tasks required by shift schedule.
  • Become a SME and qualified trainer within a designated function of manufacturing.
  • Maintain on-time completion of training assignments to maintain the necessary technical skills and process knowledge.
  • Perform other tasks as assigned: continuous improvement projects, inspection readiness, right first-time initiatives, etc.

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 include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
  • Based on eligibility, 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.
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