Senior Manager/Manager, Manufacturing

Role Summary

Fate Therapeutics is seeking a motivated and execution-driven Senior Manager/Manager to support GMP manufacturing operations of iPSC-derived allogeneic cell therapy products. This role oversees operational execution and manufacturing quality events including deviations, CAPAs, and other required change actions, and helps define and execute the company's operational strategy to enable a sustainable, scalable, and GMP-compliant manufacturing process. It requires proven leadership to drive communication, collaboration, and coordination across the Manufacturing department and with cross-functional teams at all levels of the organization. This is a full-time, exempt position located at Fate Therapeutics' corporate headquarters 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 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 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

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

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.