At Fujifilm Diosynth Biotechnologies, we are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. 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 and partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients.
We are seeking a candidate for a Senior Commercial Process Engineer (CPE) Position, within the Commercial Operations organization. The successful candidate must have a proven ability to work independently and collaboratively to achieve optimized strategies, and execute programs with the ultimate goal of delivering products that transform the lives of patients. The CPE will provide oversight for the technical execution, standardization and monitoring of commercial product(s), as well as drive continuous improvement around production, compliance and safety. The CPE will be the technical subject matter expert for core manufacturing and operational technologies: Fermentation, Cell Culture, Filtration, Centrifugation, Chromatography and Single Use Technologies.
Major Activities and Responsibilities
- Manage the revisions of Master Batch Records and Formulation Records, as well as the supporting documentation, for corrective actions, process changes, and improvements.
- Responsible for the preparation and revision of Engineering Test Plans, supplemental instructions, standard work, supplemental sample plans and other readiness documents, as well as summary reports.
- Participation and facilitation of Potential Problem Analysis (PPA) sessions and implementation/coordination of countermeasures.
- Conduct and Coordinate manufacturing process training.
- Support the manufacturing process performance of commercial batches, providing technical support on and off the production floor.
- Communicate process performance and exceptions with client.
- Perform suite GEMBA and Support of critical operation oversight and batch record review on the floor.
- Manage Deviations (open, data gathering, investigation, comment resolution) in a timely manner. Respond or coordinate response to questions, comments from QA and client.
- Support or facilitate Problem Analysis (PA) events, as needed.
- Owner of corrective and preventive measures and change controls related to the program(s).
- Support Regulatory filings and updates as needed.
- Perform process evaluation and trend analysis using statistical tools to support routine monitoring.
- Author the annual product review technical report.
- Maintain and evaluate metrics on process performance. Develop and publish to dashboard on key performance indicators.
Other Program Support
- Lead deviation investigations, assess product impact, author deviation reports and present to regulatory agencies.
- Champion process improvements and manage funding (possible capital project) and implementation of improvements for sustained results.
- Support new equipment and process validation activities.
- Provide support during audits and with audit observation closure.
- Prepare and revise SOPs and Work Instructions related directly to the commercial manufacturing processes.
- Provide process or unit operation training to new team members and periodicals, as needed.
- Attend and Participate in meetings, including tier, internal and external client calls, team huddles, business review meetings, and others as needed.
- BS/BA in science, engineering or other related field
- Minimum 7 years’ experience, with at least 4 years’ experience in the biotech industry
- Strong technical writing skills
- Good working knowledge of cGMP requirements
- Experience in developing, conducting and evaluating training
- Experience with laboratory and/or manufacturing instruments/equipment
- Experience with Biotech/pharmaceutical processes required
- Due to the various interactions with external and internal groups, interpersonal, leadership and organizational skills are essential attributes
- 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.