Manufacturing Associate II, Cell Therapy in Devens, MA
Bristol Myers Squibb
8 hours ago
On-site
Devens, MA
Operations
Manufacturing Associate II, Cell Therapy (Shifts: 6am–6pm rotating incl. holidays/weekends; or 6pm–6am rotating incl. holidays/weekends)
Responsibilities:
- Perform patient process unit operations and support operations per SOPs and batch records.
- Complete required documentation (process transfer/validation protocols, SOPs, batch records).
- Follow safety policies, quality systems, and GMP requirements.
- Complete training assignments to maintain technical skills.
- Collaborate to solve technical/operational problems; identify innovative solutions.
- Set up manufacturing areas/equipment/fixtures; assist facility and equipment commissioning.
- Train others on SOPs/Work Instructions.
- Execute daily unit operations schedule for people, product, and material flow across shifts.
- Work in cleanroom with aseptic processing; maintain controlled environmental conditions via area disinfection.
Knowledge/Skills (Preferred/Required):
- cGMP regulations and FDA guidance for biologics/cell therapy (preferred).
- Ability to work assigned shift (days/nights/weekends/holidays).
- Aseptic processing in cleanroom; comfortable with human blood components.
- Close proximity to strong magnets.
Basic Requirements:
- High school diploma and 2+ years cGMP bioprocessing manufacturing/cell therapy manufacturing (or relevant experience).
- Bachelor’s in relevant science/engineering preferred.
- Cell washing/automated equipment preferred; cell separation/automated equipment and cryopreservation a plus.
Benefits (explicitly listed):
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs, 401(k) and insurance; paid time off (flexible time off or paid vacation/holidays depending on status).
Responsibilities:
- Perform patient process unit operations and support operations per SOPs and batch records.
- Complete required documentation (process transfer/validation protocols, SOPs, batch records).
- Follow safety policies, quality systems, and GMP requirements.
- Complete training assignments to maintain technical skills.
- Collaborate to solve technical/operational problems; identify innovative solutions.
- Set up manufacturing areas/equipment/fixtures; assist facility and equipment commissioning.
- Train others on SOPs/Work Instructions.
- Execute daily unit operations schedule for people, product, and material flow across shifts.
- Work in cleanroom with aseptic processing; maintain controlled environmental conditions via area disinfection.
Knowledge/Skills (Preferred/Required):
- cGMP regulations and FDA guidance for biologics/cell therapy (preferred).
- Ability to work assigned shift (days/nights/weekends/holidays).
- Aseptic processing in cleanroom; comfortable with human blood components.
- Close proximity to strong magnets.
Basic Requirements:
- High school diploma and 2+ years cGMP bioprocessing manufacturing/cell therapy manufacturing (or relevant experience).
- Bachelor’s in relevant science/engineering preferred.
- Cell washing/automated equipment preferred; cell separation/automated equipment and cryopreservation a plus.
Benefits (explicitly listed):
- Health coverage (medical/pharmacy/dental/vision), wellbeing programs, 401(k) and insurance; paid time off (flexible time off or paid vacation/holidays depending on status).