Senior Manager/Manager, Manufacturing

Role Summary

Senior Manager/Manager, Manufacturing role focused on GMP manufacturing operations for iPSC-derived allogenic cell therapy products. Responsible for operational execution and management of manufacturing quality events, including deviations and CAPAs, and for defining/executing scalable, GMP-compliant manufacturing processes. Full-time, exempt position located in San Diego, CA.

Responsibilities

• Oversee end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCBs through harvest and cryopreservation.
• Collaborate with Quality Assurance, Supply Chain, Quality Control, MSAT, Process Development, and Facilities.
• Coordinate with departments to manage Deviations, CAPAs, Continuous Improvements, Impact Assessments, and Change Actions.
• Maintain manufacturing facility in an inspection-ready state at all times.
• Engage Materials Management, Planning and Sourcing to ensure adequate raw material inventory.
• Project management using tools such as SmartSheet and Microsoft Office.
• Ensure manufacturing staff meet and maintain cGMP training requirements.
• Develop personnel schedules for effective manufacturing execution.
• Review and approve manufacturing-related documentation.
• Lead authorship and review of SOPs and GMP BRs.
• Identify potential process improvements and design experiments to evaluate/implement changes.
• May hire, oversee, train, and motivate team members to meet goals efficiently.

Qualifications

• Bachelor‚Äôs or Master‚Äôs degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience.
• Preferred: strong manufacturing administration background related to tech transfer of aseptically produced cell products.
• Strong emphasis on quality event management and process improvement for manufacturing operations.
• Ability to create, read, review, and edit manufacturing documents including Batch Records, SOPs, Work Instructions, and forms.
• Self-motivated, flexible, prioritized, multi-tasking, and able to work in a fast-paced environment.
• Experience leading projects and managing teams.

Skills

• Leadership and cross-functional collaboration
• GMP compliance and quality event management
• Documentation management (Batch Records, SOPs, WIs)
• Project management and scheduling
• Process improvement and experimental design

Education

• Bachelor‚Äôs or Master‚Äôs degree in Life Sciences or related field

Additional Requirements

• Willingness to work in controlled and cGMP manufacturing environments requiring gowning.
• Ability to work with cells and cell lines of human and/or animal origin.
• Ability to work with hazardous materials.