Senior Manager​/Manager, Manufacturing

Overview

Fate Therapeutics is seeking a motivated and execution-driven Manager/Senior Manager to support GMP manufacturing operations of iPSC-derived allogenic cell therapy products. As part of the Manufacturing Team, this role oversees operational execution and manages manufacturing quality events including deviations, CAPAs, and other required change actions. The role helps define and execute the company s operational strategy to enable a sustainable, scalable and GMP compliant manufacturing process, and requires leadership to drive communication, collaboration, and coordination within Manufacturing and cross-functionally.

This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

• 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.
• Collaborate with Quality Assurance, Quality Control, Supply Chain, MSAT, Process Development, and Facilities.
• Coordinate with applicable departments to manage Deviations, CAPAs, Continuous Improvements, Impact Assessments and Change Actions.
• Maintain the manufacturing facility in an inspection-ready state at all times.
• Engage with Materials Management, Planning and Sourcing to ensure adequate inventory of raw materials for planned production activities.
• Project management using tools such as Smart Sheet and Microsoft Office.
• Ensure manufacturing staff meet and maintain cGMP training requirements.
• Develop personnel schedules to enable effective execution of manufacturing activities.
• Review and approve applicable manufacturing-related documentation.
• Lead authorship and review of SOPs and GMP BRs.
• Identify potential process improvements and design experiments to evaluate and implement changes.
• May hire, oversee, train, and motivate team members to meet goals efficiently.

• Bachelor’s or Master’s 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 is preferred.
• Experience with 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 related forms.
• Self-motivated, flexible, able to prioritize, multi-task, and work in a fast-paced environment.
• Experience leading projects and managing teams is required.

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

• Salary based on level, experience, qualifications, internal equity, and location.
• Competitive package including annual bonus, equity, and generous benefits.
• Anticipated salary range: $110,000 - $150,000.

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

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Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Fate s product platform focuses on multiplexed-engineered iPSC lines and manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The company s effector cell pipeline includes multiplexed-engineered, iPSC-derived NK and T-cell products with novel synthetic controls of cell function, such as CARs, to target tumor antigens and support cancer therapy combinations.

Fate Therapeutics is headquartered in San Diego, CA. For more information, visit

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