Cell Therapy Manufacturing Lead Specialist

Bristol Myers Squibb; Massachusetts; On-site; USD 55,000 - 68,000; Full time

Job summary

Bristol Myers Squibb seeks a Specialist, Lead Manufacturing Associate, Cell Therapy to join the Devens, MA team. You will execute SOP-driven operations, ensure quality, and support cross‑functional efforts in a GMP cell therapy facility.

The role requires cGMP expertise, aseptic processing in cleanrooms, and experience with cell washing, separation, and cryopreservation. On-site night shifts are available, with safety and compliance emphasis throughout.

Qualifications

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Must have the ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Must be able to work in a cleanroom environment and perform aseptic processing.
• Must be comfortable being exposed to human blood components.
• Must be able to be in close proximity to strong magnets.
• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment.
• Cell separation techniques and automated equipment.
• Cryopreservation processes and equipment.
• Experience in aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human derived materials in BSL‑2 containment areas.
• Cell expansion using incubators and single use bioreactors.

Responsibilities

• Execute operations described in standard operating procedures and batch records.
• Demonstrates strong practical and theoretical knowledge in their work.
• Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solves complex problems; takes new perspectives using existing solutions.
• Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. Completing training assignments to ensure the necessary technical skills and knowledge.
• Sets up manufacturing areas and equipment/fixtures. Perform facility and equipment commissioning activities.
• Collaborates with support groups on recommendations and solving technical problems.
• Help to ensure the shift works effectively in a team based, cross‑functional environment to complete all production tasks required by shift schedule.
• Collaborates closely with Shift Managers to ensure seamless pass down and communication of operational status.
• Supports investigations.
• Identifies innovative solutions.
• Supports writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Training others on SOPs, Work Instructions to successfully complete manufacturing operations.
• Working with production planning with leadership to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts.
• Work in a cleanroom environment and perform aseptic processing; maintain manufacturing environmental conditions (Non‑Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements.

Skills

cGMP regulations

Cleanroom environment

Aseptic processing

Cell therapy manufacturing

Cell washing

Cell separation

Cryopreservation

ISO 5 biosafety

Biosafety containment

Shift flexibility

FDA guidance

Education

Bachelor's degree in science or engineering

Job description

Bristol Myers Squibb seeks a Specialist, Lead Manufacturing Associate, Cell Therapy to join the Devens, MA team. You will execute SOP-driven operations, ensure quality, and support cross‑functional efforts in a GMP cell therapy facility.

The role requires cGMP expertise, aseptic processing in cleanrooms, and experience with cell washing, separation, and cryopreservation. On-site night shifts are available, with safety and compliance emphasis throughout.