Job Description
*2nd shift, 3-11pm*
Job Summary
The Manufacturing Supervisor provides hands-on leadership of second shift GMP manufacturing operations for microbiome Live Biologic Products. This role supervises four contract associates and ensures safe, compliant, and efficient execution of fermentation, harvest, lyophilization, media/buffer preparation, packaging, and suite readiness activities. The Supervisor serves as the primary on-site manufacturing leader during second shift and actively supports floor operations.
Responsibilities
- Supervise second shift GMP manufacturing activities, including fermentation and downstream processing.
- Lead and support four contract manufacturing associates; assign tasks and provide coaching.
- Ensure production suites, equipment, and materials are ready and compliant.
- Enforce cGMP, safety, and quality standards.
- Review batch records and documentation for accuracy and completeness.
- Execute shift schedules to meet production timelines.
- Escalate and support resolution of manufacturing issues, deviations, CAPAs, and change controls.
- Support new processes, SOP implementation, and technology transfers.
- Provide clear shift handovers and communicate production status and risks.
Qualifications
- Bachelor’s degree in Biology, Biochemistry, Engineering, or related field preferred.
- 3–6 years of GMP manufacturing experience; prior supervisory or lead experience preferred.
- Experience with fermentation, microbial processing, aseptic techniques, or lyophilization preferred.
- Strong knowledge of cGMP regulations and documentation practices.
- Experience reviewing batch records and supporting deviation management.