Senior Manager/Manager, Manufacturing

Role Summary

Senior Manager/Manager, Manufacturing overseeing GMP manufacturing operations of iPSC-derived allogenic cell therapy products. Responsible for operational execution and managing manufacturing quality events, deviations, CAPAs, and change actions. Plays a pivotal role in defining and executing operational strategy to enable sustainable, scalable, GMP-compliant manufacturing. Location: San Diego, CA.

Responsibilities

• Responsible for overseeing end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCBs through harvest and cryopreservation of drug product.
• Work effectively with Quality Assurance, Supply Chain, Quality Control, MSAT, Process Development, and Facilities.
• Coordinate with applicable departments to manage Deviations, CAPAs, Continuous Improvements, Impact Assessments and Change Actions.
• Assure manufacturing facility is maintained in an inspection-ready state at all times.
• Engage with Materials Management and Planning and Sourcing to assure adequate inventory of raw materials to support planned production activities.
• Project management utilizing tools including SmartSheet and Microsoft Office.
• Ensure manufacturing staff meet and maintain cGMP training requirements.
• Develop personnel schedules to allow effective execution of manufacturing activities.
• Review and approve manufacturing-related documentation.
• Lead authorship and review process of SOPs and GMP BRs.
• Identify potential process improvements for Manufacturing and design experiments to evaluate and implement those 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.
• Strong manufacturing administration background related to tech transfer of aseptically produced cell products (preferred).
• 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, able to prioritize, multi-task, and work in a fast-paced environment.
• Experience leading projects and managing teams.

Skills

• Leadership and cross-functional collaboration
• cGMP knowledge and quality event management
• Documentation development and review
• Project management tools (SmartSheet, MS Office)

Education

• Relevant bachelor‚Äôs or master‚Äôs degree as stated in Qualifications

Additional Requirements

• Working in controlled and cGMP manufacturing environments requiring gowning
• Handling cells and cell lines of human/animal origin and hazardous materials