Associate Scientist/Scientist, Process Sciences

Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California!  The Associate Scientist/Scientist, Process Sciences 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 designing and performing laboratory activities to support process development and process characterization of client cell therapy processes and products.  He/she will be responsible for cell processing, process scale-up/scale-down, bioreactor process parameters, cryopreservation, and equipment evaluation.

External US

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 Associate Scientist/Scientist, Process Sciences, is a critical position responsible for development activities associated with cell therapy process development and design at Fujifilm Diosynth Biotechnologies, California (FDBC).  This position provides hands-on support for all aspects of process development experimental design and execution, will be responsible for experimental process monitoring (data capturing), and process troubleshooting.  This position will work closely with and/or under the direction of a Senior or Principal Process Development Scientist.

Reports to:       Senior Director, Manufacturing Science and Technology

Location:          Thousand Oaks (northwest Los Angeles), CA

Travel:               Travel required (up to 10%)

Primary Responsibilities:

• Support instrument qualifications and change assessments.
• Author and review laboratory procedures, development reports, qualification protocols/reports, risk assessments and technical reports.
• Train Process Engineering and Manufacturing staff members on new processes or process changes.
• Supports technology transfer related activities for NPI and implementation of process changes into manufacturing from a technical, development 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 and works with team to communicate out to client.
• Evaluates and provides input to Process Sciences and clients on suitability of technologies, scalability, and manufacturability during process development activities and partners with for defining the critical process parameters of new processes.

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:

• Associate Scientist: Bachelor of Science (B.Sc.) with 3+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 1+ years of experience; or PhD in Science with 0-3 years of experience
• Scientist: Bachelor of Science (B.Sc.) with 5+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 3+ years of experience; or PhD in Science with 0-3 years of experience
• Proven ability to work with high performing teams.
• Ability to organize, structure work in a changing environment.
• Strong technical analysis, business judgment and clear decision-making.
• Excellent interpersonal skills, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
• Demonstrated experience supporting technology transfers, cGMP manufacturing operations and CMC regulatory submissions and inspections required.
• Advanced knowledge in cell biology, cell culture, cell processing and cell cryopreservation principles.
• Advanced knowledge across cell culture technologies, cell processing technologies, cell characterization methods, manufacturing under cGMP, validation, Quality Systems, and regulatory requirements.
• Demonstrated in-depth skills in designing, executing, and interpreting experiments.
• 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 a team player.
• Role model for FDBC values of trust, delighting our customers, Gemba, and Genki.

Join us!  FDB is advancing tomorrow's 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.