Manufacturing Associate

*2nd shift*

Job Summary

The Manufacturing Associate supports GMP manufacturing operations for microbiome Live Biologic Products through hands-on execution of production activities. This role is responsible for performing fermentation, harvest, lyophilization, media and buffer preparation, packaging, and equipment readiness activities while ensuring compliance with cGMP, safety, and quality standards. The Associate works closely with cross-functional teams to support efficient manufacturing operations and timely product delivery.

Responsibilities

• Perform GMP manufacturing activities, including fermentation, harvest, and downstream processing operations.
• Prepare media, buffers, and production materials according to approved procedures.
• Execute lyophilization, packaging, and labeling activities.
• Set up, clean, sanitize, and maintain production suites and manufacturing equipment.
• Complete batch records and manufacturing documentation accurately and in a timely manner.
• Adhere to cGMP, safety, and quality requirements throughout all manufacturing activities.
• Identify and communicate equipment, process, or documentation issues to manufacturing leadership.
• Support investigations, deviations, CAPAs, and change controls as needed.
• Participate in process improvements, technology transfers, and implementation of new procedures.
• Assist with inventory management, material handling, and production readiness activities.

Qualifications

• Associate's or Bachelor's degree in Biology, Biochemistry, Engineering, or a related scientific discipline preferred.
• 1–3 years of experience in GMP manufacturing, biotechnology, pharmaceutical, or related production environments.
• Experience with fermentation, microbial processing, aseptic techniques, or lyophilization is preferred.
• Basic understanding of cGMP regulations and manufacturing documentation practices.
• Ability to follow detailed procedures and accurately complete batch records.