NIGHT SHIFT: Senior Manufacturing Associate, Cell Therapy in Devens, MA
Bristol Myers Squibb
2 months ago
On-site
Devens, MA
Operations
Shifts Available
- 6pm - 6am, rotating shift 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 simple problems using existing solutions.
- Perform tasks consistent with safety policies, quality systems, and GMP requirements.
- Complete training assignments to build required technical skills and knowledge.
- Train others on SOPs and Work Instructions to support manufacturing operations.
- Support investigations.
- Identify innovative solutions.
- Assist in setting up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
- Write technically sound manufacturing operating procedures that promote effective/efficient operations and comply with cGMP.
- Work with production planning to execute daily unit operations schedules (people, product, and material flow across multiple shifts).
- Work in a cleanroom environment; perform aseptic processing and maintain environmental conditions per controlled area classification by performing required area disinfection to meet global Health Authority requirements.
Knowledge and Skills (including preferred)
- 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).
- Ability to work in a cleanroom and perform aseptic processing.
- Comfort exposed to human blood components.
- Ability to be in close proximity to strong magnets.
- Experience in cell therapy manufacturing: cell washing, cell separation, cryopreservation (processes and automated equipment).
- Preferred: 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.
Basic Requirements
- High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Bachelor’s in a relevant science or engineering discipline and relevant experience strongly preferred.
Working Conditions (summary)
- Stand/walk several hours/day; carry/lift/push/pull up to 50 lbs several times/day; climb, bend/kneel, overhead reaching, and repetitive arm/wrist/hand use.
- Wear PPE and cleanroom garments daily.
Compensation (if applicable)
- Devens, MA: US $33.51 - $40.61 per hour (full-time employee/FTE basis). Additional incentive cash/stock may be available (based on eligibility).
- 6pm - 6am, rotating shift 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 simple problems using existing solutions.
- Perform tasks consistent with safety policies, quality systems, and GMP requirements.
- Complete training assignments to build required technical skills and knowledge.
- Train others on SOPs and Work Instructions to support manufacturing operations.
- Support investigations.
- Identify innovative solutions.
- Assist in setting up manufacturing areas and equipment/fixtures; perform facility and equipment commissioning activities.
- Write technically sound manufacturing operating procedures that promote effective/efficient operations and comply with cGMP.
- Work with production planning to execute daily unit operations schedules (people, product, and material flow across multiple shifts).
- Work in a cleanroom environment; perform aseptic processing and maintain environmental conditions per controlled area classification by performing required area disinfection to meet global Health Authority requirements.
Knowledge and Skills (including preferred)
- 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).
- Ability to work in a cleanroom and perform aseptic processing.
- Comfort exposed to human blood components.
- Ability to be in close proximity to strong magnets.
- Experience in cell therapy manufacturing: cell washing, cell separation, cryopreservation (processes and automated equipment).
- Preferred: 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.
Basic Requirements
- High school diploma and 3+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing, or relevant experience.
- Bachelor’s in a relevant science or engineering discipline and relevant experience strongly preferred.
Working Conditions (summary)
- Stand/walk several hours/day; carry/lift/push/pull up to 50 lbs several times/day; climb, bend/kneel, overhead reaching, and repetitive arm/wrist/hand use.
- Wear PPE and cleanroom garments daily.
Compensation (if applicable)
- Devens, MA: US $33.51 - $40.61 per hour (full-time employee/FTE basis). Additional incentive cash/stock may be available (based on eligibility).