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.

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 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.

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 in support of manufacturing process development activities and serves as process subject matter expert in client and health authority interactions.
• Contribute substantially to the development of manufacturing processes for cell therapy processes and products, including allo CAR-T, NK cell, or other cell type products, using suspension bioreactor technologies, disposable bioreactor technology, etc.
• Design and execute process development studies to develop a thorough understanding of operating and performance parameters (Design space)
• Use engineering approaches to develop solutions to manufacturing process deficiencies
• Sets up, monitor, sample and analyze cell culture processes in development bioreactors.
• 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

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 (see above) travel is an essential part of the job.

Qualifications:

• Bachelor of Science (B.Sc.) with 10+ years of experience or an equivalent combination of education; OR
• Master of Science (M.Sc.) with 8+ years of experience; OR
• PhD in Science with 6+ years of 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.
• High level knowledge of 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 FDBC values of trust, delighting our customers, Gemba, and Genki.

Salary and Benefits:

• $115k to $160k per year, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

Join us FDB is advancing tomorrows medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.