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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.