Lead Manufacturing Associate, Cell Therapy Manufacturing
Bristol Myers Squibb
8 days ago
On-site
Devens, MA
Operations
Shifts Available:
- Day Shift (6am - 6pm)
- Rotational schedule including holidays and weekends; onsite
Responsibilities:
- Execute operations in standard operating procedures (SOPs) and batch records.
- Complete documentation for process transfer, validation, SOPs, and batch records.
- Perform work consistent with safety policies, quality systems, and GMP requirements; complete training assignments.
- Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning.
- Collaborate with support groups to solve technical problems; support investigations.
- Ensure shift execution in a team-based, cross-functional environment; coordinate pass-down and operational status with Shift Managers.
- Support writing manufacturing operating procedures compliant with cGMP.
- Train others on SOPs and work instructions.
- Coordinate daily unit operations schedules (people, product, materials) with production planning leadership.
- Work in cleanroom aseptic processing; maintain environmental conditions via required disinfection.
Knowledge & Skills (Required/Preferred):
- Knowledge of cGMP regulations and FDA guidance for biologics/cell therapy.
- Ability to work assigned shift (days/nights/weekends/holidays).
- Ability to perform aseptic processing in a cleanroom; comfort around human blood components; proximity to strong magnets.
- Experience in cell therapy manufacturing (cell washing, separation, cryopreservation) and automated equipment.
- Preferred: Aseptic processing in ISO 5 biosafety cabinets; universal precautions in BSL-2; cell expansion (incubators/single-use bioreactors).
Basic Requirements:
- 4+ years in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Bachelor’s in relevant science/engineering or equivalent experience.
- Day Shift (6am - 6pm)
- Rotational schedule including holidays and weekends; onsite
Responsibilities:
- Execute operations in standard operating procedures (SOPs) and batch records.
- Complete documentation for process transfer, validation, SOPs, and batch records.
- Perform work consistent with safety policies, quality systems, and GMP requirements; complete training assignments.
- Set up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning.
- Collaborate with support groups to solve technical problems; support investigations.
- Ensure shift execution in a team-based, cross-functional environment; coordinate pass-down and operational status with Shift Managers.
- Support writing manufacturing operating procedures compliant with cGMP.
- Train others on SOPs and work instructions.
- Coordinate daily unit operations schedules (people, product, materials) with production planning leadership.
- Work in cleanroom aseptic processing; maintain environmental conditions via required disinfection.
Knowledge & Skills (Required/Preferred):
- Knowledge of cGMP regulations and FDA guidance for biologics/cell therapy.
- Ability to work assigned shift (days/nights/weekends/holidays).
- Ability to perform aseptic processing in a cleanroom; comfort around human blood components; proximity to strong magnets.
- Experience in cell therapy manufacturing (cell washing, separation, cryopreservation) and automated equipment.
- Preferred: Aseptic processing in ISO 5 biosafety cabinets; universal precautions in BSL-2; cell expansion (incubators/single-use bioreactors).
Basic Requirements:
- 4+ years in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Bachelor’s in relevant science/engineering or equivalent experience.