Shifts Available: 6pmβ6am, rotating shift including holidays/weekends; onsite
Responsibilities:
- Execute operations per SOPs and batch records; complete required documentation.
- Perform tasks consistent with safety, quality systems, and GMP/cGMP.
- Complete training; train others on SOPs/Work Instructions.
- Support investigations; identify innovative solutions.
- Set up manufacturing areas and equipment/fixtures; perform facility/equipment commissioning.
- Write technically sound manufacturing operating procedures compliant with cGMP.
- Coordinate with production planning to execute daily unit operations schedule (people/product/material flow across multiple shifts).
- Work in cleanroom, perform aseptic processing; maintain environmental conditions via disinfection.
Knowledge & Skills / Required:
- Knowledge of cGMP and FDA guidance for biologics/cell therapy.
- Ability to work assigned shift (day/night/weekends/holidays).
- Able to work in cleanroom and perform aseptic processing; comfortable with exposure to human blood components.
- Close proximity to strong magnets.
- Experience in cell therapy manufacturing: cell washing, cell separation, cryopreservation (incl. automated equipment where applicable).
Preferred:
- Aseptic processing in ISO 5 biosafety cabinets; universal precautions in BSL-2.
- Cell expansion using incubators and single-use bioreactors.
Basic Requirements:
- High school diploma + 3+ years cGMP bioprocessing manufacturing or cell therapy manufacturing (or relevant experience).
- Bachelorβs in relevant science/engineering strongly preferred.
Compensation (Devens, MA): $33.51β$40.61/hour.
Benefits: health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability/life/accident, supplemental health, PTO options (as applicable/eligibility-based).
Application instruction: If the role doesnβt perfectly match your resume, apply anyway.