Senior Research Associate, cGMP Cell Bank Manufacturing

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Job description

Fate Therapeutics is seeking a skilled and highly motivated Senior Research Associate to participate in cGMP cell bank manufacturing in compliance with cGXP guidelines to further the development of novel off-the-shelf cellular therapeutics for the treatment of cancer and immune disorders. The successful candidate will play a key role in the advancement of the company's induced pluripotent stem cell (iPSC) platform. The candidate should have experience in cell line development and banking. Experience with cGMP manufacturing is strongly desirable. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities

• Participate in iPSC line and other cell line development and banking by adhering to established cGMP SOPs and BRs covering, but not limited to media preparation, cell culture and scale up, genetic engineering, and banking.
• Execute and document batch records and SOPs with high level of compliance to safety policies, quality system and cGMP guidance.
• Initiate and execute cell bank testing and characterization using previously established methods.
• Participate in writing or suggesting changes to controlled documents as needed to ensure defined quality objectives are met.
• Participate in evaluation of process automation for introduction into GMP manufacturing.
• Participate in process and product development activities and write research reports as needed.
• Present manufacturing activities and updates during department meetings.
• Exercises technical discretion in the design, execution, and interpretation of experiments for research programs.
• Investigates, creates, and develops new methods and technology for project advancement.
• Maintains high level of professional expertise through scientific literature and makes contributions to scientific journals.
• Works autonomously and may guide lower-level associates.

Qualifications

• BS/MS in cell biology or similar discipline with a minimum of 4+ years of experience in academic, biotechnology, or pharmaceutical setting. cGMP manufacturing experience is highly desirable.
• Demonstrated ability to work both independently and in a team-oriented environment.
• Preferred experience in any of the following:
• Hands-on experience in aseptic processing in ISO 5 BSC and ISO 7 clean rooms and universal precautions for handling human derived materials in BSL-2 containment areas
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Hands-on experience in cell therapy cGMP manufacturing
• Cell culture and scale up of iPSCs or mammalian cells
• Proficiency in pipetting technique and small-scale culturing formats (e.g.: 96w plates)
• Cryopreservation processes and equipment
• Flow cytometry

Working conditions & physical 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.

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 $85,000 to $100,000 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 .

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