Fate Therapeutics is seeking a Senior Director, MSAT to join our Manufacturing Science and Technology team. This position will lead the late-stage process development, optimization, validation, and commercialization of Fate’s off-the-shelf, induced pluripotent stem cell (iPSC) product portfolio working closely with Process Development, Analytical Development, Quality Control, Quality Assurance, Manufacturing Operations, and Regulatory. This is a full-time position reporting to Vice President, Manufacturing Science and Technology and is located at our corporate headquarters in San Diego, CA.Responsibilities
- Lead all late-stage process development and validation activities with a team of 10+ scientists/engineers.
- Assist in defining global strategies for developing, characterizing, and validating late-stage/commercial drug product processes as well as drug product in-use/administration and comparability.
- Develop and establish process control strategies required for late and commercial stage cell therapy processes.
- Drive culture of continuous improvement by identifying opportunities, making formal recommendations, and driving initiatives to completion.
- Assist in technical root cause analysis and establishment of effective CAPA for any deviations impacting the manufacture or release of final product at internal and external manufacturing sites.
- Author, review and approve technical reports, qualification/validation protocols, and guidance documents.
- Oversee relevant CMC sections regulatory submissions and serve as a subject matter expert in regulatory interactions.
- Build and develop a high performing team to deliver results, drive innovation and continuous improvement.
- Serve as a member of the Manufacturing Science and Technology leadership team as well as the extended Technical Operations leadership team
Working Conditions and Physical Requirements
- PhD or MS in Biological Sciences, Chemistry, Chemical Engineering, Biomedical Engineering, or Immunology.
- Minimum 12 years of experience for PhD or 15 years of experience for MS in pharmaceutical or biotech industry. Experience in cell and gene therapy technology development preferred.
- At least 8 years managing day-to-day and mentoring the professional development of direct reports.
- Comprehensive knowledge of drug product comparability and administration, process characterization/process validation, process monitoring, process control strategy, technical transfer, as well as GxP regulations, guidance, and industry best practices; Technical Operations and/or Quality experience a plus.
- Demonstrated experience authoring CMC sections and interacting with global health authorities.
- Ability to analyze and develop solutions to complex problems.
- Leadership experience in managing multiple stakeholders, prioritizing responsibilities, and allocating resources to maximize results.
- Proven track record of building collaborative cross-functional relationships both internally and externally, skilled in resolving conflicts, and able to compromise to achieve objectives.
- Excellent interpersonal, verbal, written and presentation skills with the ability to clearly explain complex concepts, findings, and rationale to a variety of audiences, from entry level associates to executive leaders.
- Comfortable in a fast-paced small company environment with the ability to be agile when adjusting workload based upon changing priorities.
- Occasional evening and weekend work will be required
- 100% on-site work at corporate headquarters in San Diego, CA
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