Senior Manager/Manager, Manufacturing

Role Summary

Fate Therapeutics is seeking a motivated and execution-driven Manager/Senior Manager to support GMP manufacturing operations of iPSC-derived allogenic cell therapy products. This role oversees operational execution and manages manufacturing quality events to enable a sustainable, scalable, and GMP-compliant manufacturing process, requiring strong leadership and cross-functional collaboration within the Manufacturing department and across the organization. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

Responsibilities

• Responsible for overseeing end-to-end GMP production of iPSC-based drug product from media preparation and thaw of MCB’s through harvest and cryopreservation of drug product.
• Work effectively with other groups including 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 teams to assure adequate inventory of raw materials to support planned production activities.
• Project management utilizing tools including but not limited to SmartSheet and Microsoft Office tools.
• Assure manufacturing staff meet and maintain cGMP training requirements.
• Develop personnel schedules to allow effective execution of manufacturing activities.
• Review and approve applicable manufacturing-related documentation.
• Lead authorship and review process of SOPs and GMP BRs.
• Identify potential process improvements for Manufacturing and design appropriate experiments to evaluate and implement those changes.
• May hire, oversee, train, and motivate team members, ensuring that team goals are met efficiently.

Qualifications

• Bachelor’s or Master’s degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience is required.
• A strong manufacturing administration background specifically related to tech transfer of aseptically produced cell products is preferred.
• A strong emphasis on quality event management and process improvement for manufacturing operations
• Ability to create, read, review, and edit manufacturing related documents including Batch Records, SOP’s, Work Instructions and associated forms.
• Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced & dynamic environment.
• Experience leading projects and managing teams is required.

Education

• Bachelor’s or Master’s degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience is required.

Additional Requirements

• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
• Will require working with cells and cell lines of human and/or animal origin.
• Will require working with hazardous materials.
• Will require work in controlled and cGMP Manufacturing environments requiring special gowning.