Senior Scientist / Scientist, Analytical Development

Description:

Fate Therapeutics is seeking a highly-motivated individual with extensive assay development and flow cytometry expertise to join the analytical development team. The successful candidate will be responsible for developing analytical methods in support of the development of novel, off-the-shelf, engineered iPSC-derived NK and T cell therapies. Operating in a cross-functional and dynamic environment, the individual will work closely with Quality Control, Process Development, Manufacturing Sciences and Technology, Product Development, Regulatory Affairs, and Manufacturing teams. The ideal candidate should have a proven track record of developing, implementing, and transferring QC- suitable analytical testing methods that are compliant with regulatory requirements. This is a full-time position reporting to the Director, Analytical Development and is located at our corporate headquarters in San Diego, California.

Primary Responsibilities:

• Lead development and evaluation of fit-for-use analytical test methods in accordance with ICH guidelines for the measurement of quality attributes of engineered NK and T cell products.
• Design, execute, and document method development studies and coordinate qualification activities.
• Perform previously established methods in support of process development, product release and stability, and product characterization needs.
• Perform data analysis and data trending to track assay performance.
• Manage assay transfer to the QC team and external partners.
• Draft and review relevant regulatory write-ups for newly-developed methods.
• Coordinate activities within a collaborative work environment across key groups to support method development as well as the characterization of Fates products.
• Provide mentorship and support to other teams developing analytical methods, as a technical expert.
• Follow good documentation and review practices, and effectively communicate scientific results and strategies in presentations and written reports.
• Draft technical reports, standard operating procedures, and test protocols in support of analytical test method development.
• May be responsible for managing direct reports

Requirements:

• Ph.D. in Biological Sciences or other related field and 2+ years of experience or M.S. / B.S. and 5+ years of experience in a biopharmaceutical organization for Scientist position. Ph.D. and 5+ years or M.S./B.S. and 8+ years for Senior Scientist position.
• Well-versed in various immunology and molecular biology techniques with expertise in flow cytometry and one or more of the following techniques: cellular imaging, immunoassays, or PCR.
• Proven successful development of robust flow cytometry and cell-based analytical test methods, preferably for cell therapy products.
• Requires a strong background in bioanalytical development, as well as a knowledge of cGMPs, ICH, and relevant FDA guidelines and experience in writing relevant regulatory submissions.
• Excellent interpersonal, verbal and written communication skills.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Expertise in stem cell biology, immunology and/or cancer biology is strongly preferred.
• Experience leading, mentoring, and supervising team members.

Working Conditions and Physical Requirements:

• 100% on-site work at corporate headquarters in San Diego, CA
• Occasional evening and weekend work will be required

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.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first- in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.