Principal Scientist / Senior Scientist, Process Development

Location
San Diego, CA, United States
Posted
Oct 17, 2020
Ref
418RC
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Fate Therapeutics is seeking an experienced and highly motivated Process Development Scientist to join the iPSC-Derived T Cell (iT) Process Development team. In this role the successful candidate will work with internal and external partners to support pre-clinical and clinical process development,
product characterization, technology transfer and validation studies associated with the implementation of cGMP-compliant manufacturing processes and systems required for Fate's iT cell therapy products. This position requires prior experience in a process development position, extensive experience with mammalian cell culture and immunological techniques such as flow cytometry and in vitro cell based assays and the ability to mentor and lead a team within a matrix environment. Prior experience with cell therapy is a plus. This is a full-time position reporting to an Associate Director, and is located at our corporate headquarters in San Diego, CA.

Responsibilities:
• Design, perform and analyze process development projects to support CMC IND-related
activities
• Identify and evaluate new/innovative technologies, material and procedures related to cGMP compliance and streamlined process workflow
• Develop and oversee technology transfer protocols from Process Development laboratory to both internal and external cGMP manufacturing facilities
• Act as a Subject Matter Expert (SME) to train others in area of expertise. Collaborate cross-
functionally with Research & Development, Manufacturing, Quality Control, Quality Assurance, Regulatory and Clinical groups.
• Responsible for preparation of project plans and data review presentations as needed for internal and external discussions

Qualifications
• Ph.D. in cell biology, immunology or closely related field and 5+ year of experience or
M.S./B.S. and 8+ years of experience in biotech or pharmaceutical environment
• Prior experience and knowledge of mammalian cell culture is required
• Prior experience in upstream Process Development is required
• Prior experience in multi-color flow cytometry and data analysis is preferred
• Knowledge of T cell biology or other immunological subsets is a plus
• Knowledge of manufacturing sciences and technology transfer is recommended
• Knowledge of statistical design of experiments (DOE)
• Strong organizational and record keeping skills
• Excellent interpersonal, verbal and written communication skills are critical

Working Conditions and Physical Requirements
• 100% on-site work at corporate headquarters in San Diego, CA.
• Evening and weekend work as reasonable and necessary
• Occasional traveling may be required
• Will require working with cells and cell lines of human and/or animal 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. For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com and
reference job 418RC.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. 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 product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include 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, and a myeloid-
derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.