Manufacturing Associate, CAR-T, Manufacturing Operations

Manufacturing Associate, CAR-T, Manufacturing Operations (Harvest)

This role is responsible for manufacturing human blood-derived components per Standard Operating Procedures (SOPs) in a controlled, cGMP cleanroom environment under the supervision of Manufacturing Management. Production tasks are performed within a team according to an assigned, production shift schedule.

• Quad 2:
  Sunday – Wednesday (e/o Wednesday off), Onsite Night Shift, 5 p.m. – 5:30 a.m.
• Quad 4:
  Wednesday – Saturday (e/o Wednesday off), Onsite Night Shift, 5 p.m. – 5:30 a.m.

• 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. Assist on time closure of any assigned CAPAs within the designated shift.
• Practice aseptic technique and gowning for welding, connections, and transfers; ISO7/ISO5 qualification required.
• Weigh and measure in‑process materials to ensure proper quantities are added or 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 the shift schedule.
• Motivated, team‑concious individuals are needed to fulfill job requirements.
• Become an 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.
• Perform other tasks as assigned: continuous improvement projects, inspection readiness, right‑first‑time initiatives, etc.
• Ensure all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Record patient material handling data and information in a clear, concise format according to proper GDPs.
• Able to solve problems with minimal supervision.
• Other duties may be assigned as necessary.
• Available to work overtime when business requires.

• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Background that includes an understanding of biology, chemistry, medical or clinical practices.

• High School Diploma required;
  Bachelor’s or associate degree preferred.
• 0‑1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience.

• Ability to stand or walk for extended periods.
• Ability to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets with required gowning and PPE.
• Required to carry or lift up to 30 pounds (15 kg) several times a day while handling production equipment or materials.
• Required to push or pull up to 50 pounds (25 kg) several times a day while handling equipment or materials.
• Work may involve areas with strong magnets.
• Must work in a BSL2 / ML1 work environment handling human blood components.
• Must be able to work assigned shift (Day, Evening, Night, Weekends, and/or Holidays).

Summit West – NJ – US: $27.83 – $33.72 per hour (full‑time employee). Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.

• Health Coverage:
  Medical, pharmacy, dental and vision care.
• Well‑being 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.

Paid Time Off: US Exempt Employees: flexible time off…