Specialist, Lead Manufacturing Associate, Cell Therapy in Devens, MA

Shifts Available:
- Day Shift (6am–6pm)
- Rotational schedule including holidays and weekends (onsite)

Responsibilities:
- Execute operations per SOPs and batch records; complete required documentation.
- Perform/maintain GMP-compliant work; complete required training.
- Set up manufacturing areas/equipment/fixtures; perform facility/equipment commissioning.
- Collaborate cross-functionally; coordinate with Shift Managers for pass-down/operational status.
- Support investigations and help solve complex/technical problems.
- Support writing/maintaining manufacturing operating procedures (cGMP); identify innovative solutions.
- Train others on SOPs/work instructions.
- Execute daily unit operations schedule with production planning (people/product/material flow).
- Work in cleanroom; perform aseptic processing and maintain environmental conditions.

Knowledge/Skills:
- Knowledge of cGMP and FDA guidance for biologics/cell therapy.
- Ability to work assigned shifts (day/night/weekends/holidays).
- Aseptic processing; comfort with human blood components.
- Ability to work near strong magnets.
- Cell therapy manufacturing experience: cell washing, cell separation, cryopreservation; preferred: ISO 5 cabinets/BSL-2 universal precautions.
- Cell expansion experience (incubators, single-use bioreactors).

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

Benefits (high level): Health coverage, wellbeing support, 401(k) and insurance/disability; paid time off.

Application instructions:
- If not a perfect resume match, still apply.