Scientist / Associate Scientist, Analytical Development

Location
San Diego, CA
Posted
Jan 20, 2022
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Fate Therapeutics is seeking a skilled and motivated individual with assay development and molecular biology expertise to join the Product Characterization and Analytical Development team. The successful candidate will be responsible for developing PCR-based 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 test methods that are compliant with regulatory requirements. This is a full-time position reporting to a Senior Scientist, Analytical Development and is located at our corporate headquarters in San Diego, California.
Primary Responsibilities
  • Isolate and quantitate nucleic acids from cell lines, primary human cells, and iPSC-derived drug products for confirmation of identity, quantitation of gene expression, and characterization of cell purity.
  • Develop and optimize PCR-based assays for product characterization and quality control testing of iPSC-derived drug products.
  • Analyze data, interpret results, trend data and maintain detailed records.
  • Draft and review standard operating procedures, reports, and relevant regulatory write-ups for newly-developed methods.
  • Follow good documentation practices, where applicable.
  • Design and execute assay qualification and validation studies.
  • Manage assay transfer to the QC team and external partners.
  • Coordinate activities within a collaborative work environment across key groups to support method development as well as the characterization of Fate’s products.
  • Provide mentorship and support to other teams developing analytical methods, as a technical expert.
  • Maintain knowledge of and critically evaluate scientific literature and industry trends in order to contribute maximally to Fate’s analytical development efforts.

Requirements
  • Ph.D. in Biological Sciences or other related field and 2+ years of experience or M.S. / B.S. and 7+ years of experience in a biopharmaceutical organization.
  • Well-versed in various molecular biology analytical techniques.
  • Proven successful development of PCR-based analytical methods.
  • Excellent interpersonal, verbal, and written communication skills.
  • Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
  • Prior nucleic acid isolation and quantitation experience is required.
  • Prior qPCR experience is required.
  • Prior ddPCR and next-generation sequencing experience is preferred.
  • Prior cell culture experience is preferred.
  • Expertise in stem cell biology, immunology and/or cancer biology is preferred.
  • Prior experience with one or more of the following equipment is preferred: NanoDrop
  • Spectrophotometer, Qubit Fluorometer, Bio-Rad QX200 ddPCR system, Bio-Rad QX ONE ddPCR
  • system, Bio-Rad CFX96 Real Time PCR System.

Working Conditions and Physical Requirements
  • 100% on-site work at corporate headquarters in San Diego, CA
  • Occasional evening and weekend work will be required
  • Will require working with cell lines of human origin



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.

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.