Manufacturing Associate, CAR-T, Manufacturing Operations

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

This role is responsible for manufacturing human blood‑derived cell therapy components in a cGMP cleanroom environment. The position operates under the supervision of Manufacturing Management and follows all regulatory and internal quality requirements.

• Quad 2:
  Sunday – Wednesday (evening or Wednesday off)
• Quad 4:
  Wednesday – Saturday (evening or Wednesday off)
• On‑site night shift: 5p.m. – 5:30a.m.

• Set up and operate equipment for cell culture, harvest, and cryopreservation of blood component lots.
• Support deviation investigations and author write‑ups.
• Close CAPAs assigned to the shift in a timely manner.
• Apply aseptic technique and gowning for welding, connections, and transfers; maintain ISO7/ISO5 qualification.
• Weigh and measure in‑process materials to ensure accurate quantities.
• Adhere to the production schedule and internal logistics.
• Record production data in GDP‑compliant format.
• Perform tasks in accordance with site safety, quality systems, and GMP requirements.
• Collaborate within a cross‑functional team to complete scheduled production tasks.
• Assist with continuous‑improvement projects, inspection readiness, and first‑time-right initiatives.
• Ensure accurate documentation and address errors promptly.
• Record patient material handling data in GDP‑compliant format.
• Problem‑solve independently with minimal supervision.
• Participate in overtime when required.
• Develop into a subject‑matter expert and qualified trainer for assigned manufacturing functions.

• Understanding of cGMP and FDA regulations.
• Basic mathematical ability.
• Technical writing skills.
• Proficiency with MS Office.
• Background in biology, chemistry, or related medical/clinical practice.

• High School Diploma required.
• Bachelor’s or Associate’s degree preferred.
• 0–1 year experience in cGMP cell‑therapy or bioprocessing manufacturing.

• Stand/walk for extended periods.
• Operate in a cleanroom with ISO5 biosafety cabinets; gowning and PPE including safety shoes, glasses, and full gown.
• Lift up to 30lb (15kg) and push/pull up to 50lb (25kg) several times per day.
• Work in BSL‑2/ML‑1 environment handling human blood components.
• Versatility for day, evening, night, weekend, and holiday shifts.

Summit West – NJ – US: $27.83 – $33.72 per hour. Additional incentives may be available based on eligibility.

• Medical, pharmacy, dental, and vision coverage.
• Well‑being programs and Employee Assistance Program.
• 401(k) retirement plan.
• Paid time off and flexible time off options.
• Paid holidays, including optional holidays.
• Voluntary health and life insurance options.
• Supplemental health coverage and disability plans.
• Employee wellness and engagement initiatives.
• Global shutdown and summer hours (where applicable).

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