Job Description — Manufacturing Associate (3rd Shift, Contract)
Location: Watertown, MA
Shift: 11:00 PM – 7:30 AM
Summary
The Manufacturing Associate supports GMP production of microbiome Live Biologic Products (LBPs), executing core manufacturing activities while ensuring compliance with cGMP, safety, and quality standards. This is a hands‑on, overnight role working under minimal supervision.
Key Responsibilities
- Perform GMP manufacturing operations (fermentation support, harvest, lyophilization, media/buffer prep, packaging)
- Follow SOPs and batch records to ensure accurate, compliant execution
- Set up, clean, and sanitize equipment and production areas
- Monitor processes and elevate issues or deviations as needed
- Maintain cGMP, aseptic, and safety standards
- Support environmental monitoring and in‑process checks
- Assist with investigations, CAPAs, and process improvements
- Ensure clear shift handovers and maintain 5S standards
Qualifications
- High school diploma required; associate or bachelor’s preferred
- 1–3 years of GMP or regulated manufacturing experience
- Basic knowledge of cGMP and documentation practices
- Experience with aseptic processing or bioprocessing a plus
- Strong attention to detail and ability to follow procedures
- Comfortable working independently on overnight shift
Requirements
- Ability to work in cleanroom environments and wear PPE
- Able to stand for extended periods and perform light lifting
- Reliable availability for 3rd shift (11:00 PM – 7:30 AM)