Senior Scientist, Cell Therapy Process Development

Overview

At FUJIFILM Biotechnologies California, we’re driving the future of medicine with the expertise to produce life-changing cell therapies like T-cell and CAR T immunotherapies. Working with pioneering biotech partners, our teams manufacture innovative treatments that improve lives.

Join us at our advanced Thousand Oaks facility, where you’ll make a tangible impact on groundbreaking therapies. We offer a collaborative, flexible workplace and a vibrant culture driven by passion and energy—what we call Genki. If you’re ready to reimagine the future of healthcare, let’s create something extraordinary together.

Our campus is in Thousand Oaks, California, an exceptional place to live with great schools, natural beauty, outdoor activities, and proximity to Los Angeles and Santa Barbara.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

Job Description

Primary Responsibilities:

• Provide strong scientific leadership and hands-on support for all aspects of technology transfer, process development and scale-up, lab scale process monitoring, and process troubleshooting, and supporting regulatory submissions as needed.
• 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.
• Identify and qualify critical or custom reagents, disposable required for development activities.
• Design and execute process development studies to develop a thorough understanding of operating and performance parameters (Design space). Implement science-based approaches and cGMP requirements in the selection of critical raw materials and components.
• Provides Process Sciences assessments on suitability of technologies, scalability, and manufacturability during process development activities and partners with Process Engineering and clients for defining the critical process parameters of new processes.
• Provides significant technical depth to support troubleshooting efforts during development activities.
• Assess suitability of technologies, equipment, and methodologies to provide a competitive advantage for our service offering and efficiency/effectiveness of client programs.
• Provide leadership in process development assessments for potential clients.
• Partners with cross-functional teams such as the Cell Therapy Business leaders, Process Engineering, Technology Transfer/New Product Introduction to ensure successful development and transfer, into the site, of all client cell therapy manufacturing processes.
• Develop study templates that can serve as platforms for multiple cell types or processing modules, as applicable
• Author, review and approve process development reports, process qualification protocols/reports, risk assessments, standardization unit operations modules, and technical reports, laboratory procedures.
• Train Process Development and/or Process Engineering and Manufacturing staff members.
• Drives timely decisions and facilitates active cross-functional technical communication and information flow between team members.
• Supports technology transfer related activities for NPI and implementation of process changes into manufacturing from a technical perspective.
• Partners with Process Engineering and NPI teams to identify and drive process optimization initiatives and addresses opportunities for efficiency and capacity improvements in all areas of internal and external manufacturing.
• Authors IND, NDA, and other technical documents for regulatory agency submission in support of manufacturing process development activities and serves as process subject matter expert in client and health authority interactions.
• Use engineering approaches to develop solutions to manufacturing process deficiencies
• Performs multiplexed cell-based assays (killing assays, mixed lymphocyte reactions, proliferation assays, etc.) for process assessment and product characterization.
• Provide leadership to more junior…