Job Description

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
• Complete documentation (batch records, logbooks) in real time
• Set up, clean, and sanitize equipment and production areas
• Monitor processes and escalate 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)

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