Manufacturing Associate, CAR-T, Manufacturing Operations

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.
• Utilize aseptic technique and gowning for most activities: welding, connections, and transfers; possess ISO 7/ISO 5 qualification.
• 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 consistently 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.
• Be a motivated, team‑conscious individual required to fulfill job responsibilities.
• Become a subject‑matter expert and qualified trainer within a designated manufacturing function.
• Receive supervision from the shift Supervisor or designated Team Lead.
• Maintain on‑time completion of training assignments to retain necessary technical skills and process knowledge.
• Perform additional 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.
• Problem‑solve with minimal supervision.
• Accept other duties as assigned, as necessary.
• Be available to work overtime when business requires.

• Knowledge of cGMP/FDA‑regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficiency in MS Office applications.
• Background in 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.

• Must be able to stand or walk for extended periods of time.
• Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets, wearing appropriate PPE (safety shoes, safety glasses, aprons, face shields, PAPR, lab coats, full‑body gowns, hairnets, gloves, hearing protection).
• Required to carry and/or lift up to 30 pounds (15 kg) several times a day while handling production equipment and/or materials.
• Required to push and/or pull up to 50 pounds (25 kg) several times a day while handling production equipment and/or materials.
• Work in areas that may contain strong magnets.
• Must be able to work in a BSL2/ML1 environment handling human blood components.
• Must be able to work the assigned shift (day, evening, night, weekend, and/or holiday).

Summit West - NJ - US: $27.83 – $33.72 per hour.

The starting compensation range for this role is listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, location, work schedule, job‑related knowledge, and experience. 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 (unlimited, with manager approval, 11 paid national holidays). Phoenix, AZ, Puerto Rico and Rayzebio exempt, non‑exempt, hourly employees: 160 hours annual paid vacation for new hires…