Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA
Bristol Myers Squibb
9 hours ago
On-site
Devens, MA
Operations
Shifts Available
- Day Shift (6am–6pm)
- Night Shift (6pm–6am)
- Rotational schedule including holidays and weekends, onsite
Responsibilities
- Execute operations described in standard operating procedures (SOPs) and batch records.
- Complete documentation required by process transfer protocols, validation protocols, SOPs, and batch records.
- Demonstrate strong practical and theoretical knowledge; solve complex problems using existing solutions.
- Perform tasks in compliance with safety policies, quality systems, and GMP requirements; complete training assignments.
- Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
- Collaborate with support groups to recommend and solve technical problems.
- Ensure effective, team-based cross-functional shift execution of production tasks.
- Collaborate with Shift Managers for seamless pass-down and operational status communication.
- Support investigations.
- Identify innovative solutions.
- Support writing technically sound manufacturing operating procedures that 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 (people, product, and material flow across multiple shifts).
- Work in a cleanroom, perform aseptic processing, and maintain required environmental conditions via area disinfection.
Knowledge and Skills (Required/Preferred)
- Knowledge of cGMP regulations and FDA guidance for biologics and cell therapy manufacturing.
- Ability to work assigned shifts (Day/Night/Weekends and/or Holidays).
- Ability to work in a cleanroom and perform aseptic processing.
- Comfortable exposure to human blood components.
- Ability to work in close proximity to strong magnets.
- Experience in cell therapy manufacturing: cell washing (automated equipment), cell separation (automated equipment), cryopreservation (processes/equipment).
- Preferred: aseptic processing in ISO 5 biosafety cabinets; universal precautions for handling human-derived materials in BSL-2.
- Preferred/Experience: cell expansion using incubators and single-use bioreactors.
Basic Requirements
- 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Bachelor’s in a relevant science/engineering discipline, or equivalent experience.
Working Conditions
- Stand/walk while operating equipment for several hours; may require carrying/lifting/pushing/pulling up to 50 lbs several times/day.
- Climb stepladders/stairs; bend/kneel; overhead work up to 25 lbs; head/neck movement and twisting; repetitive arm/wrist/hand use.
- Wear PPE and cleanroom garments daily.
Compensation (as stated)
- Devens, MA: $43.84–$53.12 per hour (FTE). Additional incentive cash/stock may be available (eligibility-based).
Benefits (only as explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support programs; 401(k), disability, life insurance, accident insurance, supplemental health insurance, and other listed protection/support benefits.
- Paid Time Off: flexible time off options and paid holidays/vacation as described; additional eligible time off (e.g., paid sick time, volunteer days, leaves of absence, Global Shutdown).
Application Instructions (as stated)
- If submitting via this posting, apply through the company’s recruitment process; no specific instructions beyond the listed contact info are included.
- Day Shift (6am–6pm)
- Night Shift (6pm–6am)
- Rotational schedule including holidays and weekends, onsite
Responsibilities
- Execute operations described in standard operating procedures (SOPs) and batch records.
- Complete documentation required by process transfer protocols, validation protocols, SOPs, and batch records.
- Demonstrate strong practical and theoretical knowledge; solve complex problems using existing solutions.
- Perform tasks in compliance with safety policies, quality systems, and GMP requirements; complete training assignments.
- Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
- Collaborate with support groups to recommend and solve technical problems.
- Ensure effective, team-based cross-functional shift execution of production tasks.
- Collaborate with Shift Managers for seamless pass-down and operational status communication.
- Support investigations.
- Identify innovative solutions.
- Support writing technically sound manufacturing operating procedures that 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 (people, product, and material flow across multiple shifts).
- Work in a cleanroom, perform aseptic processing, and maintain required environmental conditions via area disinfection.
Knowledge and Skills (Required/Preferred)
- Knowledge of cGMP regulations and FDA guidance for biologics and cell therapy manufacturing.
- Ability to work assigned shifts (Day/Night/Weekends and/or Holidays).
- Ability to work in a cleanroom and perform aseptic processing.
- Comfortable exposure to human blood components.
- Ability to work in close proximity to strong magnets.
- Experience in cell therapy manufacturing: cell washing (automated equipment), cell separation (automated equipment), cryopreservation (processes/equipment).
- Preferred: aseptic processing in ISO 5 biosafety cabinets; universal precautions for handling human-derived materials in BSL-2.
- Preferred/Experience: cell expansion using incubators and single-use bioreactors.
Basic Requirements
- 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Bachelor’s in a relevant science/engineering discipline, or equivalent experience.
Working Conditions
- Stand/walk while operating equipment for several hours; may require carrying/lifting/pushing/pulling up to 50 lbs several times/day.
- Climb stepladders/stairs; bend/kneel; overhead work up to 25 lbs; head/neck movement and twisting; repetitive arm/wrist/hand use.
- Wear PPE and cleanroom garments daily.
Compensation (as stated)
- Devens, MA: $43.84–$53.12 per hour (FTE). Additional incentive cash/stock may be available (eligibility-based).
Benefits (only as explicitly listed)
- Health coverage (medical, pharmacy, dental, vision); wellbeing support programs; 401(k), disability, life insurance, accident insurance, supplemental health insurance, and other listed protection/support benefits.
- Paid Time Off: flexible time off options and paid holidays/vacation as described; additional eligible time off (e.g., paid sick time, volunteer days, leaves of absence, Global Shutdown).
Application Instructions (as stated)
- If submitting via this posting, apply through the company’s recruitment process; no specific instructions beyond the listed contact info are included.