Senior Manager/Manager, Manufacturing

Fate Therapeutics•San Diego, CA

2d•$110,000 - $150,000•Onsite

About The Position

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 an integral part of the Manufacturing Team, this role is responsible for overseeing operational execution in addition to managing manufacturing quality events including deviations, CAPAs, and other required change actions. This individual will play a pivotal role in defining and executing the company's operational strategy to enable the execution of a sustainable, scalable and GMP compliant manufacturing process. Accordingly, this role will require proven leadership abilities to drive meaningful communication, collaboration and coordination both internally within the Manufacturing department as well as cross-functionally across all levels of the organization. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

Requirements

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.

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.