We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.
The Commercial Process Engineer II is part of the Manufacturing Organization. The individual in this role works under general supervision with the latitude for independent judgment. This role provides day-to-day leadership and oversight for the monitoring of commercial product(s), as well as continuous improvement around production, compliance and safety for supported programs. This position requires an understanding of core manufacturing and operational technologies for the manufacturing unit, which include: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography. Additionally, this position will be responsible for supporting deviation investigations, internal and regulatory document updates, as well participating in client and regulatory audits.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Essential Job Functions:
Support the Readiness, Execution and Post Execution activity for commercial process (es) as part of the Manufacturing Commercial Operations team. Provide ownership for process deviations, as well as client and regulatory document updates and inspections.
- Revisions of Master Batch Records and Formulation Records
- Responsibility for preparation, revision and execution of ETPs, supplemental instructions, standard work, coordination of supplemental sample plans and other readiness documents
- Participation on Potential Problem Analysis (PPA) sessions and implementation/coordination of countermeasures
- Conduct and Coordinate manufacturing process training
- Support the manufacturing process performance of commercial batches as the technical lead
- Support/Lead program GEMBAs
- Support oversight for critical operations on the floor
- Provide updates/escalations to Upper Management or Clients
- Support Coordinators to ensure records are timely, accurate and complete for QA review. Respond or coordinate response to questions, comments from QA and client
- Manage Deviations (open, data gathering, investigation, comment resolution) in a timely manner
- Support Problem Analysis (PA) events, as needed
- Own corrective and preventive measures and change controls related to the program(s)
- Maintain and evaluate metrics on process performance
- Perform process surveillance and trend analysis using statistical tools for routine monitoring and the annual product review report.
Other Program Support
- Own deviation impact assessments and program deviations, as needed
- Support new equipment and process validation activities, as needed
- Prepare and revise SOPs and WI related directly to the commercial manufacturing processes
- Provide process or unit operation training to new team members and periodically, as needed
- Attend and participate in meetings, including tier meeting, internal and external client calls, team huddles, business review meetings, and others as needed
- Typically has direct impact on program deliverables and performance
- Helps drive Commercial Operations team results
- BS/BA in science, engineering or other related field
- Minimum 4+ years’ experience or MS or equivalent
- Demonstrates practical understanding of biological process manufacturing, process experimental design and problem solving
- Demonstrates knowledge of complex instrumentation, computer systems and software for data acquisition and analysis
- Good working knowledge of cGMP requirements
- Strong interpersonal, leadership and organizational skills due to the various interactions with external and internal groups
- Ability to work in a cross functional team environment
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.