NIGHT SHIFT: Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA

NIGHT SHIFT:
Specialist, Lead Manufacturing Associate, Cell Therapy – Devens, MA

Posted 1 week ago. Be among the first 25 applicants.

This role focuses on supporting routine manufacturing operations for cell therapy, ensuring safety, quality, and compliance with cGMP. The position is essential to maintaining efficient production during the night shift and requires strong problem‑solving and teamwork skills.

Night Shift (6pm – 6am). Rotational schedule including holidays and weekends, onsite.

• Execute operations described in standard operating procedures and batch records.
• Demonstrate strong practical and theoretical knowledge in their work.
• Complete documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records.
• Solve complex problems; take new perspectives using existing solutions.
• Perform tasks in a manner consistent with safety policies, quality systems, and GMP requirements. Complete training assignments to ensure necessary technical skills and knowledge.
• Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
• Collaborate with support groups on recommendations and solving technical problems.
• Help ensure the shift works effectively in a team‑based, cross‑functional environment to complete all production tasks required by the shift schedule.
• Collaborate closely with Shift Managers to ensure seamless pass‑down and communication of operational status.
• Support investigations.
• Identify innovative solutions.
• Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements.
• Train others on SOPs and work instructions to successfully complete manufacturing operations.
• Work with production planning and 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.

• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
• Ability to work assigned shift (Day, Night, Weekends and/or Holidays).
• Experience working in a cleanroom environment and performing aseptic processing.
• Comfortable being exposed to human blood components.
• Experience working in close proximity to strong magnets.
• Experience in cell therapy manufacturing, including cell washing processes and automated equipment, cell separation techniques, cryopreservation processes and equipment.
• Preferred:
  Aseptic processing in ISO 5 biosafety cabinets, universal precautions for handling human‑derived materials in BSL‑2 containment areas.
• Experience with cell expansion using incubators and single‑use bioreactors.

• 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience.
• Bachelor’s in a relevant science or engineering discipline, or equivalent work experience.

• Stand and Walk – Required to stand/walk while operating manufacturing/computer equipment for several hours at a time, throughout the day.
• Carrying weight, Pushing, Pulling, Lifting – Required to carry, lift, push, and/or pull up to 50 pounds several times a day while handling production equipment and/or materials.
• Climb – Required to climb (use of stepladders in production areas, or stairwells) several times a day.
• Bend and Kneel – Required to bend or kneel several times a day.
• Overhead work – Required to perform overhead reaching during handling of production materials/files/supplies up to 25 pounds several times a day, throughout the day.
• Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day, throughout the day.
• Twisting – Required movement of twisting…