Principal Scientist

Position Overview

The Principal Scientist, Manufacturing Sciences and Technology (MSAT) will report to the head of Process & Analytical Development and Manufacturing Science & Technology (MSAT) at the FUJIFILM Biotechnologies, Thousand Oaks, CA 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 Principal Scientist, Process Development is responsible for process development activities associated with client processes and cell therapy production at Fujifilm Biotechnologies, Thousand Oaks, CA.   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.

Company 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: https://www.fujifilm.com/us/en/about/region/careers

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 team members.
• Document laboratory procedures and experiments with great attention to detail in laboratory notebooks
• Assist in the development of standard operating procedures, analytical test methods, and analytical sampling plans
• Author, review, and approve laboratory procedures.
• Support instrument qualifications

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. Car and airplane travel is an essential part of the job.

Qualifications:

• Bachelor of Science (B.Sc.) in biochemistry, cell therapy, biology, immune therapy or similar OR 12+ years of similar experience or an equivalent combination of education and experience; OR
• Master of Science (M.Sc.) in biochemistry, cell therapy, biology, or immune therapy or similar OR 10+ years of similar experience or an equivalent combination of education and experience ; OR
• PhD in biochemistry, cell therapy, biology, immune therapy or similar OR 8+ years of similar experience or an equivalent combination of education and experience. 
• 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.
• 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.
• Demonstrated experience supporting technology transfers, cGMP manufacturing operations and CMC regulatory submissions and inspections required.
• Expert knowledge of cell and gene therapy, cell biology, cell culture, cell processing and cell cryopreservation principles.
• Breadth of knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under cGMP, and regulatory requirements.
• Demonstrated in-depth skills in designing, executing, and interpreting experiments and experimental data.
• 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.
• Flexibility to travel as required to accommodate business needs
• Expert problem-solving skills.
• Effective interpersonal skills as both a team leader and a team player.
• Role model for FUJIFILM Biotechnologies values of trust, delighting our customers, Gemba, and Genki.

Salary and Benefits:

• The base salary range for this position is $150,000-210,000. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

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EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).