Cellares
Supervisor, Manufacturing
South San Francisco, CA
Sponsorship not specified$90k-$210kDetected 15 days ago
SAPSupply ChainProcess ImprovementPerformance ManagementGMPFDA RegulatoryCRISPRLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMentoringLean Manufacturing
About the role
- The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
- Lead, direct, coach, and develop an effective manufacturing team responsible for daily clinical and commercial/clinical production of autologous and allogeneic cell therapy products, while ensuring safe and compliant operations according to cGMP requirements
- Lead and oversee manufacturing processes including engineering runs, PPQ and APS
- Operate in a controlled GMP environment and perform gowning as per procedure
- Perform routine procedures following written instructions (SOPs, batch records, solution documents, protocols, etc.)
- Execute manufacturing processes in both an R&D and GMP environments, following protocols and/or standard operating procedures (SOPs)Understands all operations, functions, capability of equipment and ancillary support to equipment, is able to operate said equipment and is able to perform complex troubleshooting
- Review in-process and completed documents for accuracy including SAP issuance of materials and assure documentation is turned in to area management within specified days of completion
- Initiate, investigate, and support the closure of Deviation Reports, CAPAs and Change Controls
- Coordinate and perform routine cleanroom and laboratory activities including ordering, cleaning, restocking, and equipment qualification/maintenance
Requirements
- Bachelor's degree in science, engineering, or related field required
- Substantial knowledge of Quality Systems, GMP, FDA, GAMP, ISO and other applicable standards
- Demonstrated experience in managing GMP manufacturing operations and on time delivery of quality products
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
Nice to have
- A minimum of 6+ years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 3 years leadership experience.
- Cell/Gene Therapy experience required, CDMO experience preferred.
- With experience in tech transfer, process validation, and change management
- Experience with Operational Excellence and/or Lean Manufacturing.
- Lean Six Sigma certification preferred
Compensation
- $90k-$210k
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