Shifts Available:
- 6pm - 6am, rotating shift including holidays and weekends, onsite
Responsibilities:
- 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 & Skills (Required/Preferred):
- 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
Basic Requirements:
- High school diploma and 3+ yearsβ cGMP bioprocessing/manufacturing or cell therapy manufacturing/relevant experience
- Bachelorβs in relevant science/engineering strongly preferred
Compensation/Benefits (if applicable per posting):
- Devens, MA: $33.51β$40.61/hour
- Health coverage; wellbeing support; 401(k); disability and life insurance; paid time off; additional leave options (eligibility-based)