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

Shifts Available

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

• Execute operations per SOPs and batch records; complete required documentation (SOPs, batch records, validation/process transfer protocols)
• Perform tasks consistent with safety policies, quality systems, and GMP/cGMP requirements
• Complete training assignments; train others on SOPs and work instructions
• Support investigations; solve simple problems using existing solutions; identify innovative solutions
• Assist in setting up manufacturing areas/equipment/fixtures; perform facility/equipment commissioning activities
• Write technically sound manufacturing operating procedures complying with cGMP
• Work with production planning to execute daily unit operations schedule across shifts
• Perform aseptic processing in a cleanroom; maintain environmental conditions via area disinfection to meet global Health Authority requirements

• Knowledge of cGMP regulations and FDA guidance for biologics/cell therapy manufacturing
• Ability to work assigned shift (day/night/weekends/holidays)
• Ability to work in cleanroom and perform aseptic processing; comfort with exposure to human blood components; close proximity to strong magnets
• Experience in cell therapy manufacturing: cell washing/sep, cryopreservation (processes/equipment); preferred: ISO 5 aseptic processing in biosafety cabinets; BSL-2 universal precautions; cell expansion using incubators and single-use bioreactors

• High school diploma and 3+ years’ cGMP bioprocessing/manufacturing or cell therapy manufacturing/relevant experience
• Bachelor’s in relevant science/engineering strongly preferred

• Devens, MA: $33.51–$40.61/hour
• Health coverage; wellbeing support; 401(k); disability and life insurance; paid time off; additional leave options (eligibility-based)