Commercial Process Engineer

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 Manufacturing Technology Support (MT&S) at FDBU group is seeking a Commercial Product Engineer. This is a high-level position in MT&S. The ideal candidate provides leadership and oversight for the day-to-day design, development, standardization and maintenance of an operational biotechnology utilized in the manufacture of a commercial product.  This person would become the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include of select commercial processes: Fermentation, Cell Culture/Single Use Technology, Filtration, Centrifugation and Chromatography.

Essential Job Functions:

Support the Readiness, Execution and Post Execution activity for commercial process (es) as part of the manufacturing and MTS team.  Ownership for product execution and batch release success, and a key member of the internal project team with client interactions.

Readiness

  • Preparation of Master Batch Records and formulation records and revisions.
  • Responsibility for preparation and revision of, ETPs, supplemental instructions, standard work, coordination of supplement sample plans and other readiness documents.
  • Facilitation on Potential Problem Analysis (PPA) sessions and implementation/coordination of countermeasures.
  • Conduct and Coordinate manufacturing training.
  • Review weigh schedule, buffer preparation schedule and overall equipment readiness to ensure program success.

Execution

  • Oversee manufacturing of process of commercial batches.
  • Assist production shifts to ensure smooth execution with minimal deviations.  On time start 90%, on time 90% end and success criteria of 95%.
  • Daily Suite GEMBA and Support of critical operation oversight and batch record reviews on the floor.
  • Assist with PASX issues and MO closure.

Post Execution

  • 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 or facilitate Problem Analysis (PA) events, as needed.
  • Owner of corrective and preventive measures and change controls related to the program(s)
  • Performing process evaluation using statistical tools and perform trend analysis.
  • Maintain metrics on process performance.   Develop and publish to dashboard on key performance indicators.

Other Program Support

  • Champion process improvements and managed of 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 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, and team huddles, business review meetings, and others as needed.

Background Requirements

  • A BS/BA in science, engineering or other related field is required.
  • Minimum 10 years of experience is required. At least 5 years’ experience in the biotech industry is required.  Plant experience is required.
  • Good working knowledge of cGMP requirements
  • Experience in developing training materials required
  • Experience conducting and evaluating training required
  • Experience with laboratory and/or manufacturing instruments/equipment required
  • Experience with Biotech/pharmaceutical processes required
  • Previous leadership experience required
  • Due to the various interactions with external and internal groups, interpersonal, leadership and organizational skills are essential attributes. Must have the 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.

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