Senior Scientist / Scientist, Process Development

Location
San Diego, CA
Posted
Jul 09, 2021
Ref
482CC
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time

Description:

Fate Therapeutics is seeking a skilled and highly motivated cell biologist to join our companys Process Development team to support the companys off-the-shelf cellular immunotherapy programs. The successful candidate will be part of a multidisciplinary team to develop robust and consistent manufacture process for iPSC-derived NK (iNK) and T (iT) cell products. This role will be responsible to support preclinical activities including product characterization, process optimization, and pilot productions to identify key process parameters. This position requires prior experience in cellular therapy and process development, with a proven record in optimizing mammalian cell culture and developing assays for immune cell characterization. Prior experience in cGMP environment is a plus. This is a full-time position reporting to a Principal Scientist, Process Development, and is located at our corporate headquarters in San Diego, CA.

Responsibilities:

  • Design, perform and analyze complex multi-stage process parameters to identify critical process parameters in iNK and/or iT production.
  • Evaluate or identify new methods or technologies to monitor critical quality attributes of reagents and materials utilized in the differentiation process.
  • Act as a subject matter expert from PD to collaborate with internal or external R&D, manufacturing, assay development, regulatory and QC teams for technology or method transfer.
  • Train and supervise junior staff members in supporting CMC/IND related activities, including but not limited to protocol driven studies to support process change, pre- manufacture pilot production, and method qualification.
  • Present data to Process Development team, R&D, Tech Ops, and larger program-specific teams.
  • Management of reagent inventory and communication to relevant team members.

Qualifications:

  • Ph.D in cell biology, immunology, bioengineering or closely related field with 5+ years of experience in biotech or pharmaceutical environment
  • Track record in process development of cellular therapy is highly desirable
  • Extensive hands-on experience with iPSC/ESC differentiation or immune cell culture
  • Prior experience in performing laboratory techniques such as, but not limited to, multi- color flow cytometry, cell-based assays such as proliferation and killing assays, cytokine detection, single cell RNAseq, and familiar with in vivo/in vitro cell models relevant to immune cell function
  • Prior experience in automations such as ClinicMACS Prodigy, LOVO processing is preferred
  • Extensive knowledge in QbD, DOE, statistic data analysis is a plus
  • Prior experience in transfer methods or process to cGMP manufacturing is a plus
  • Strong organization skills and ability to multitask
  • Strong communication, writing, and presentation skills
  • Ability to multi-task and work effectively in a dynamic and fast-paced setting
  • Positive outlook, willingness to learn, and a desire to work collaboratively in a team environment
  • People management skills a plus

Working Conditions and Physical Requirements:

  • Will require working with cells and cell lines of human and/or animal origin
  • Will require working with hazardous materials
  • 100% on-site work at corporate headquarters in San Diego, CA
  • Evening and weekend work as necessary

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). The Company’s pipeline also includes ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease in patients with hematologic malignancies undergoing allogeneic stem cell transplant. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.