Senior Director, Head of Process Development and Technical Services

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki.  This leadership role is responsible for the Process Development function at Fujifilm Diosynth Biotechnologies California (FDBC). FDBC provides development, manufacturing, testing, product release, and distribution of cell therapy products in partnership with our clients. The facility’s on-site laboratory and production spaces are designed to support early phase clinical to commercially approved products across a range of cell types, including CAR-T and MSC’s. The Process Development and Technical Services team is responsible for developing and optimizing manufacturing-ready processes for production of cell-based therapeutics, process transfer and process change implementation, and on-the-floor manufacturing technical and investigational support.

External US

Sr. Director, Head of Process Development and Technical Services

 

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy, and drive - what we call Genki.

 

This leadership role is responsible for the Process Development function at Fujifilm Diosynth Biotechnologies California (FDBC). FDBC provides development, manufacturing, testing, product release, and distribution of cell therapy products in partnership with our clients. The facility’s on-site laboratory and production spaces are designed to support early phase clinical to commercially approved products across a range of cell types, including CAR-T and MSC’s. The Process Development and Technical Services team is responsible for developing and optimizing manufacturing-ready processes for production of cell-based therapeutics, process transfer and process change implementation, and on-the-floor manufacturing technical and investigational support.

 

The Head of Process Development and Technical Services shall apply their demonstrated capabilities in process development across a wide range of cell types to expand the team and grow the capabilities of the FDBC Process Development, Material Science and Process Engineering functions. Prior experience in the development of new processes, process optimization and characterization, tech transfer, and commercial production support / regulatory filing is required.

 

The Head of Process Development and Technical Services will be a member of the Site Leadership Team that has responsibility for ensuring the site achieves its aspiration of being the Partner of Choice for companies working to advance their cell therapy products through the product development and commercialization life cycle. The Site Leadership Team works together to ensure we have the facilities and organizational capabilities to create value for our customers and their patients, our employees, and our community while delivering on the financial commitments to our stakeholders.  

 

Reports to:     FDBC Site Head

Location:        Thousand Oaks, CA

Travel:            Travel required (up to 20%)

 

Primary Responsibilities:

 

• Lead the Process Development team in developing manufacturing processes to deliver effective and robust production of client’s cell-based therapeutics. Optimize cell culture and processing methodologies, cell selection and separation technologies, cell characterization methods, and process equipment selection meeting cGMP, Quality Systems, and regulatory requirements.
• Conduct process characterization studies to support implementation, validation, and regulatory filings.
• Identify and verify critical process parameters for new processes.
• Design, execute, and interpret experiments to demonstrate process capability.
• Utilize science-based approaches and cGMP requirements in the selection of