NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA
Listed on 2025-11-12
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Manufacturing / Production
Pharmaceutical Manufacturing, Operations Engineer, Manufacturing Engineer, Validation Engineer
Night Shift: Specialist, Lead Manufacturing Associate, Cell Therapy (Devens, MA)
Night Shift (6:00 pm – 6:00 am) with a rotational schedule that includes holidays and weekends. Onsite work in a biosafety level‑2 environment. Located in Devens, MA.
Responsibilities- Execute operations described in standard operating procedures and batch records.
- Demonstrate strong practical and theoretical knowledge in cell therapy manufacturing.
- Complete documentation required by process transfer protocols, validation protocols, SOPs, and batch records.
- Resolve complex problems using existing solutions and innovative approaches.
- Perform tasks in compliance with safety policies, quality systems, and GMP requirements.
- Set up manufacturing areas and equipment; commission and test facilities and equipment.
- Collaborate with support groups on technical problem‑solving and procedural recommendations.
- Ensure the shift functions effectively in a team‑based, cross‑functional environment.
- Collaborate closely with Shift Managers for seamless communication of operational status.
- Support investigations and root cause analyses.
- Identify and implement innovative solutions to improve processes.
- Assist in writing manufacturing operating procedures that are technically sound and cGMP compliant.
- Train others on SOPs and work instructions for manufacturing operations.
- Coordinate with production planning to execute daily unit operations schedules.
- Work in a cleanroom environment, performing aseptic processing and maintaining environmental conditions.
- Perform area disinfection regimens to meet global health authority requirements.
- Minimum of 4+ years of experience in cGMP bioprocessing or cell therapy manufacturing.
- Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.
- Must be able to work assigned shift (day, night, weekends, and/or holidays).
- Knowledge of cGMP regulations and FDA guidance for biologics and cell therapy manufacturing.
- Experience with cell washing, automated equipment, cell separation, and cryopreservation processes.
- Experience in aseptic processing in ISO 5 biosafety cabinets and BSL‑2 containment areas.
- Comfortable handling of human blood components and exposure to strong magnets.
- Ability to work in a cleanroom environment and perform aseptic processing.
- Ability to understand and apply incubation and single‑use bioreactor cell expansion protocols.
- Stand, walk, and stay active while operating equipment for several hours.
- Carry, lift, push, or pull up to 50 lb multiple times per day.
- Use stepladders or stairwells, and bend or kneel frequently.
- Perform overhead reaching up to 25 lb while handling materials.
- Move head/neck and twist waist as required during setup and processing.
- Use personal protective equipment (PPE) and cleanroom garments daily.
Location:
Devens, MA. Pay Range: $43.84 – $53.12 per hour for full‑time, full‑time, full‑time. Eligibility for incentive cash and stock options may apply. Final individual compensation is based on demonstrated experience.
- Medical, pharmacy, dental, and vision coverage.
- Well‑being programs (BMS Living Life Better, employee assistance programs).
- 401(k) plan with company match.
- Short‑ and long‑term disability, life insurance, supplemental health insurance.
- Paid national holidays, optional holidays, and flexible “Global Shutdown Days.”
- Paid vacation up to 120 hrs and paid volunteer days.
- Family‑care benefits (adoption, fertility, caregiver, military leave).
- Tuition reimbursement and recognition programs.
We are an equal‑opportunity employer and encourage qualified applicants, including those with disabilities, to apply. Reasonable accommodations are available during the application and employment process. For more information, visit All jobs are open to the full spectrum of qualified candidates.
Additional InformationAll BMS locations require employees to be fully vaccinated for COVID‑19 and keep up to date with boosters. We consider qualified applicants with arrest and conviction records in accordance with applicable laws. If you are a California resident or expect to work from Los Angeles County, see additional local instructions at
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