Fate Therapeutics hiring for Senior Director

Fate Therapeutics seeking for Senior Director

Fate Therapeutics is seeking a highly motivated Senior Director, Manufacturing Science and Technology (MSAT), to provide technical and organizational leadership to develop solutions in support of clinical and commercial manufacturing for internal and external manufacturing operations.

Post Name:- Senior Director / Manufacturing Science and Technology (MSAT)

•  The position will provide program leadership for IND projects, liaison with Manufacturing, Process Science and Assay Development, Quality Assurance, Quality Control, Regulatory, Clinical and various project stakeholders to promote Product Development aims.
• The ideal candidate should have experience in the area of cell therapy and/or biologics 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:-

•  The primary responsibility of MSAT is to establish, characterize and maintain GMP manufacturing processes in a state of control.
• Defining and operationalizing, in collaboration with Process Science and Assa Development, a strategy to ensure commercially viable and robust product manufacturing.
• Evaluation of bioreactor process, new scale up technology and process automation for introduction into GMP manufacturing.
• Defining and developing the next generation of production capabilities. Manage internal and external collaborations to attract key technologies. Educate and train team members and stakeholders on new technologies.
• Establish and lead teams to source, vet, qualify, and implement cell manufacturing equipment, supplies, reagents, infrastructure.
• Set and delivers on challenging KPIs to drive more effective performance.
  Understanding external business & regulatory environments, proactively identifies performance risks, and develops effective mitigation strategies by leveraging a network mindset.
• Manufacturability assessment and Due Diligence.
• Technology transfer, technical support & training on the production floor.
• Process monitoring & control, Data science, MES.

Qualifications:-

•  PhD in relevant Science or Engineering discipline with minimum 10 years’ experience.
• Strong knowledge of global compliance and manufacturing operations.
• Background in Cell Therapy Manufacturing required.
• Skilled in cell culture and aseptic processing; experienced with closed culture systems and cell processing equipment and techniques; knowledgeable of critical process parameters associated with cell culturing, harvesting and cryopreservation processes.
• Understanding of technology transfer including transitioning of research techniques into cGMP production methods and start-up of existing or new
• processes at internal and external manufacturing facilities.
• Demonstrated experience building and leading exceptional teams.
  Work collaboratively with Program Leaders from all functional areas (i.e. Quality, Regulatory Affairs, Clinical, Research and Operations).
• Ability to assess, mediate, and resolve complex issues.
• Ability to build and maintain relationships in a matrix organization using collaborative approaches to achieve mutual goals.
• Ability to effectively lead teams and manage staff.
• Ability to effectively communicate scientific and technical concepts, program objectives, data analysis within a matrix environment.

Physical Requirements:-

•  80% on-site work at corporate headquarters in San Diego, CA and potentially 20% travel.
• Evening and weekend work as necessary.

Website:- fatetherapeutics.com

For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com and reference job 251WW.