Vice President, Analytical Development

Location
San Diego, CA, United States
Posted
Apr 04, 2021
Ref
456WW
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is seeking a Vice President (VP), Analytical Development (AD), to provide technical and organizational leadership to develop analytical testing solutions in support of clinical and commercial manufacturing for internal and external manufacturing operations. The AD team plays a key role in delivering a critical scientific approach to understand and optimize cell product
attributes that improve patient outcomes. In collaboration with our company's Research, Quality Control (QC), Quality Assurance (QA), Process Development (PD), Manufacturing Science and Technology (MSAT), and Regulatory teams and external partners, the VP, AD will be in charge of creating and delivering on early stage candidate analytical strategies that will lead to successful commercialization. The ideal candidate will have experience in the area of cell/gene therapy and be aware of the pertinent regulations and how they apply to these fields. This is a full-time position reporting to the SVP, Technical Operations and is located at our corporate headquarters in San Diego, CA.

Responsibilities
• Develop strong functional partnerships and phase appropriate strategies with other
corporate functions and execute on aligned strategies to support clinical development and commercialization plans.
• Accountable for the success of AD operations to deliver on the aligned priorities of the organization.
• Lead the design and execution of phase-appropriate analytical strategies including analytical method development, justification of specifications, reference standard characterization,
product characterization. and establishment of test methods to enable product QC and batch release, extended characterization, formulation development, comparability assessments and stability programs for iPSC derived NK and T cell products from the development stage to commercialization.
• Implement a testing infrastructure to partner with other technical operations teams in the delivery and interpretation of analytical data.
• Collaborate with QC to establish and execute overall analytical lifecycle management strategy.
• Avoid delays and ensure accuracy of data through prompt resolution of technical issues, troubleshooting, review deviation events and assay failure investigations in coordination with internal and external QC, QA, and regulatory groups, as appropriate.
• Provide technical input for OOS and OOT investigations.
• Drive continuous improvement to the test methods through technological innovation to
support ongoing product development effort.
• Provide technical support to internal and external cGMP analytical operations.
• Support global regulatory filings that relate to AD.
• Support product-related inspections for US and foreign regulatory agencies as needed.

Qualifications
• Doctoral (Ph.D.) degree in relevant Science with 10+ years of industrial AD experience, or MS, BS with equivalent experience.
• Experience with analytical development of cell/gene therapy in various stages of
development (preclinical to commercialization).
• Extensive analytical method development, troubleshooting, and validation experience. In-depth experience with the development and validation of analytical methods (flow cytometry, PCR, ELISA and cell-based bioassay, cell therapy potency assay etc.).
• Strong knowledge of GLP and cGMP, worldwide regulatory requirements, current industry
practices and cell/gene therapy CMC activities. Solid understanding of current industry trends and regulatory expectations associated with analytical science areas, including but not limited to stability studies, microbial control, comparability evaluation, cell-based assays, potency assays and method validation.
• Understanding of technology transfer including transitioning of research assays into cGMP analytical methods and tech transfer existing or new testing methods to internal and external manufacturing facilities.
• Experience preparing and updating regulatory filings (IND, BLA, MAA).
• Demonstrated experience building and leading exceptional teams. Leadership qualities of the successful candidate include the following: developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision.
• Self-motivated, excellent time management, organizational, and proven problem-solving skills.
• Ability to manage multiple projects, prioritize objectives, and manage resources to achieve
established deadlines.
• Outstanding written and verbal communication skills. Ability to effectively communicate scientific and technical concepts, program objectives, data analysis within a matrix environment.
• Knowledge of the principles and practices of budgeting and financial management.
• Knowledge of Quality by Design, Process Analytical Technologies and Six Sigma systems and approaches is desirable.

Working Conditions and Physical Requirements
• 80% on-site work at corporate headquarters in San Diego, CA and potentially 20% travel
• 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 from time to time. For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com and reference job456WW.

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.