Senior Operations Manager, Manufacturing and Quality

7 days ago


San Diego, California, United States Fate Therapeutics Full time
About the Role

We are seeking a highly skilled Senior Manager/ Manager, Manufacturing to join our team at Fate Therapeutics. As a key member of our Manufacturing Team, you will be responsible for overseeing the aseptic cell-based manufacturing operations at our facility.

Responsibilities

* Oversee 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.
* Ensure the 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.
* Ensure manufacturing staff meet and maintain cGMP training requirements.
* Develop personnel schedules to allow effective execution of manufacturing activities.
* Provide regular feedback to direct reports and perform mid-year and end-of-year reviews.
* Review and approve applicable manufacturing-related documentation.
* Lead authorship and review process of SOPs and GMP BRs.
Qualifications

* Bachelor's or Master's degree in a relevant discipline with 6+ years of Life Science GMP Manufacturing experience.
* 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.
About Us

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. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products.

What We Offer
The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location. Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package. The anticipated salary range for this role is $130,000 to $155,000 per year.

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