Join FUJIFILM Diosynth Biotechnologies in our new facility location - Thousand Oaks, California! The Senior Manager, Process Engineering will report directly to the Director, Manufacturing Science and Technology at the FUJIFILM Diosynth Biotechnologies. The job holder will be responsible for leading the Process Engineering team in day-to-day operations. They will ensure decisions are made timely and will facilitate active cross-functional technical communication and information flow between team members.
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 Senior Manager, Process Engineering, is a critical leadership position responsible for technical support activities associated with cell therapy production at Fujifilm Diosynth Biotechnologies, California (FDBC). This position provides leadership within a high performing team that provides on-the-floor manufacturing support to address deviations, supports validation readiness activities, champions change control and CAPA, as well as regulatory submissions, is responsible for providing strong scientific leadership and hands-on support for all aspects of technology transfer, process scale-up, process monitoring, and manufacturing process troubleshooting, as needed. This position has a strong cross-functional partnership with the leaders of Internal and External Manufacturing and Quality to ensure successful development of all manufacturing processes.
Reports to: Director, Manufacturing Science and Technology
Location: Thousand Oaks (northwest Los Angeles), CA
Travel: Travel required (up to 20%)
- Lead the Process Engineering team in day-to-day operations.
- Provides significant technical depth to support troubleshooting efforts and leads high-level deviation investigations at internal and external manufacturing facilities.
- Drives timely decisions and facilitates active cross-functional technical communication and information flow between team members.
- Champion process related change controls and new product / process introductions (NPIs) across manufacturing network.
- Supports technology transfer related activities for NPI and implementation of process changes into manufacturing from a technical perspective.
- Partners with Manufacturing and Quality 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 input to Process Sciences on suitability of technologies, scalability, and manufacturability to during process development activities and partners with for defining the critical process parameters of new processes.
- Authors IND, NDA, and other technical documents for regulatory agency submission in support of manufacturing processes and serves as process subject matter expert in health authority interactions.
- Supports Validation readiness activities across manufacturing network.
- 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.
- Bachelor's degree preferred in biology, manufacturing, engineering, or related scientific field (advanced degree preferred).
- 10+ years of experience within Technical Operations functions (e.g., Process Development, Manufacturing, Analytical Development) working for a pharmaceutical, biotechnology, or biologics company.
- 5+ years of experience leading teams in a management role.
- Proven ability to build and lead high performing teams.
- 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.
- Fundamental knowledge in 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, 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.
- Expert problem-solving skills.
- Effective interpersonal skills as both a team leader and a team player.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.