NIGHT SHIFT: Senior Manufacturing Associate, Cell Therapy in Devens, MA

Shifts Available

• 6pm - 6am, rotating shift including holidays and weekends, onsite

• 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 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.

• 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.

• 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.

Devens, MA: US $33.51 - $40.61 per hour (full-time employee/FTE basis). Additional incentive cash/stock may be available (based on eligibility).