Senior Director, Head of Process Development and Technical Services

Overview:

The work we do at FDB has never been more importantand 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 peoples 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 facilitys 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 MSCs. 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.

Sr. Director, Head of Process Development and Technical Services

The work we do at FDB has never been more importantand 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 peoples 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 facilitys 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 MSCs. 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 clients 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 critical raw materials and components.
• Apply technical and scientific expertise to support troubleshooting efforts and leads high-level deviation investigations for all manufacturing processes and programs.
• Drive timely decisions and facilitates active cross-functional, technical communication and information flow between team members and functions.
• Provide technical support for process related change controls and new product / process introductions (NPIs) across manufacturing network.
• Deliver documentation for technology transfer during process development phases and implementation of process changes for NPIs into manufacturing.
• Collaborates with Manufacturing and Quality teams to identify and drive process optimization initiatives and addresses opportunities for efficiency and capacity improvements in all areas of internal and external manufacturing.
• Assess suitability of technologies, equipment, and methodologies to provide a competitive advantage for our service offering and efficiency/effectiveness of client programs.
• Develops and leads the site strategy for process development and technology transfer service offering.
• Authors and/or supports IND, NDA, and other technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions.
• Attract, hire, develop, and motivate scientists, engineers, and associates necessary to deliver important responsibility of the Process Development and Technical Services team.
• Manage budget and staffing requirements for the department.

Physical Demands:

Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, manufacturing plant, or clinical environment.

Qualifications:

Education and Professional Requirements:

• PhD, Doctoral of Science preferred with 10+ years of relevant experience; or Master of Science 12+ years of experience; or Bachelors degree with 15+ years of relevant experience
• Minimum 5 years of leadership or management experience.
• Demonstrated experience supporting and leading process development activities, technology transfers, cGMP manufacturing operations, and CMC regulatory submissions and inspections required.
• Depth of knowledge of cell biology, cell culture, cell processing and cell cryopreservation principles.
• Depth of knowledge with cell culture and processing technologies and analytical characterization methods.
• Broad experience working within cGMP guidelines, Quality Systems, and regulatory requirements.
• Demonstrated in-depth skills in designing, executing and interpreting experiments.
• Experience with identification, selection, and implementation of cGMP compliant raw materials and components.
• Demonstrated track record of effective leadership including the management of scientists, engineers, and associates in a clinical and commercial manufacturing setting.
• Prior CDMO experience is desirable.
• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
• Excellent management skills: training, performance management, planning, prioritization, objective setting, meeting management, and plan execution.
• Strong communication skills (e.g., clear, and concise), team player, and proven negotiation skills.
• Good decision-making with strong judgment through collaboration and consideration of others point-of-view.
• Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment.
• Expert problem-solving skills.
• Ability to organize, structure and staff the organization in a changing environment.
• Strong leadership presence with ability to garner respect through sound technical analysis, business judgment and clear decision-making.
• Role model for FujiFilm and Fujifilm Diosynth Biotechnologies values and people fundamentals.

Salary and Benefits:

• $230,000 to $290,000, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.