Lead Manufacturing Associate, Cell Therapy Manufacturing

Shifts Available:
- Day Shift (6am–6pm)
- Rotational schedule 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 in line with safety, quality systems, and GMP; complete training.
- Set up manufacturing areas/equipment; support facility/equipment commissioning.
- Collaborate with support groups; solve technical problems and support investigations.
- Support cross-functional shift execution and communicate operational status with Shift Managers.
- Support writing/manufacturing SOPs compliant with cGMP.
- Train others on SOPs/work instructions.
- Work with production planning to execute daily unit schedules (people/product/material flow).
- Work in cleanroom for aseptic processing and maintain environmental conditions.

Knowledge & Skills / Qualifications:
- cGMP and FDA guidance knowledge for biologics/cell therapy.
- Ability to work assigned shift (day/night/weekends/holidays).
- Cleanroom aseptic processing; comfortable with human blood components; near strong magnets.
- Experience in cell therapy manufacturing: cell washing/automation, cell separation/automation, cryopreservation/automation.
- Preferred: aseptic processing in ISO 5 biosafety cabinets; universal precautions in BSL-2; cell expansion (incubators/single-use bioreactors).

Basic Requirements:
- 4+ years cGMP bioprocessing or cell therapy manufacturing experience.
- Bachelor’s in relevant science/engineering or equivalent experience.

Compensation (Devens, MA, US): $40.05–$48.53/hour (FTE). Final pay based on experience.