Fate Therapeutics is seeking a talented and highly motivated individual to oversee the aseptic cell-based manufacturing operations at Fate. As an integral part of the Manufacturing Team, this role is responsible for managing deviations, CAPAs, and other required change actions. The successful candidate will be able to work and influence across different departments of the organization, as well as leading the Manufacturing team’s daily operations. 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.
- 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.
- May hire, oversee, train, and motivate team members, ensuring that team goals are met efficiently.
- Identify potential process improvements for Manufacturing and design appropriate experiments to evaluate and implement those changes.
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.
Working Conditions
- 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.
Compensation
- 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.
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
Equal Employment Opportunity
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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About Fate Therapeutics, Inc.
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. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
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