Principal Scientist, Process Development

Overview

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Principal Scientist, Manufacturing Sciences and Technology (MSAT) will report directly to the Senior Director, Manufacturing Science and Technology at the FUJIFILM Diosynth Biotechnologies, California site. The job holder will be responsible for establishing laboratory capabilities, designing, and performing laboratory studies to support process development activities, assessing novel processes and technologies, etc.  They will ensure decisions are made timely and will facilitate active cross-functional technical communication and information flow between internal team members and clients.

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Principal Scientist; Process Development

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Principal Scientist, Manufacturing Sciences and Technology (MSAT) will report directly to the Senior Director, Manufacturing Science and Technology at the FUJIFILM Diosynth Biotechnologies, California site. The job holder will be responsible for establishing laboratory capabilities, designing, and performing laboratory studies to support process development activities, assessing novel processes and technologies, etc.  They will ensure decisions are made timely and will facilitate active cross-functional technical communication and information flow between internal team members and clients.

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.

The Principal Scientist, Manufacturing Sciences and Technology (MSAT) is a critical position responsible for process development activities associated with client processes and cell therapy production at Fujifilm Diosynth Biotechnologies, California (FDBC).  This position provides leadership within a high performing team that will provide process development assessments for potential clients, is responsible for providing 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.  This position has a strong cross-functional partnership with 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.

Reports to:       Senior Director, Manufacturing Science and Technology

Location:          Thousand Oaks (northwest Los Angeles), CA

Travel:               Travel required (up to 20%)

Primary Responsibilities:

• Develop study templates that can serve as platforms for multiple cell types or processing modules, as applicable  
• Author, review, and approve laboratory procedures 
• Support instrument qualifications
• Author, review and approve laboratory procedures, process development reports, process qualification protocols/reports, risk assessments, standardization unit operations modules, and technical reports  
• Identify and qualify critical reagents required for development activities 
• Train Process Development and/or Process Engineering and Manufacturing staff members
• Provides significant technical depth to support troubleshooting efforts during development activities.
• 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.
• 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.
• Authors IND, NDA, and other technical documents for regulatory agency submission