Manufacturing Cell Processing Supervisor

Minimum 4 years of experience in GMP-regulated manufacturing required.

7+ years of manufacturing experience may substitute for a degree.

Strong knowledge of cGMP regulations and quality systems applicable to biologics manufacturing.

Experience with aseptic processing and cleanroom manufacturing environments.

Understanding of FDA and EMA regulatory requirements for biologics manufacturing.

Familiarity with environmental monitoring and facility control procedures

Lead daily manufacturing operations and supervise production personnel to ensure safe, compliant, and efficient execution of manufacturing activities in a cGMP aseptic manufacturing environment.

Maintain a strong presence on the manufacturing floor during critical process steps and support troubleshooting as needed.

Oversee execution of the production schedule and coordinate staffing, suite readiness, and raw material availability in partnership with Supply Chain and cross-functional teams to ensure on-time delivery of manufacturing plans.

Ensure accurate and timely completion and review of manufacturing documentation including batch records, logbooks, deviations, change controls, and ERP transactions to support compliant production and batch release.

Maintain compliance with cGMP, regulatory, and safety requirements while ensuring continuous inspection readiness and supporting internal and external regulatory audits.

Support operational improvements and technology transfer activities, including implementation of new processes from Product Development to Manufacturing, participation in continuous improvement initiatives, and development of technical documentation such as SOPs and deviations.