Director, Program Design for Advanced Therapy Programs

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 Program Design Director will be the technical lead for potential projects from customers; leading technical discussions and presenting Fujifilm Diosynth’s experience, expertise and leadership in viral-derived advanced therapy production, including but not limited to gene therapy and viral vectors. They will proactively engage with both commercial and process development teams at all locations (with Texas focused) to scope and draft compelling and innovative proposals to support the commercial team in winning new business with a focus on advance therapy opportunities.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

The jobholder will be responsible for providing technical support with an emphasis on viral-derived advanced therapy products for the FDBK site to the commercial team particularly for potential customers located in the United States. Specific job requirements are:

  • To act as the technical lead for opportunities, particularly advance therapy, Texas based opportunities, but representing all of Fujifilm’s capabilities (microbial, mammalian and viral production) and sites (FDBU, FDBK ,and FDBT).
  • Present Fujifilm’s technical leadership to potential customers during face to face meetings and teleconferences, with an emphasis on advanced therapy opportunities
  • Lead technical interactions with potential customers ensuring a full understanding of customer requirements
  • Develop comprehensive, innovative and compelling proposals which reflect our experience and expertise, helping to differentiate Fujifilm from competitors, with a focus on advance therapy product proposals. Lead technical interactions, explaining and defending proposals to customers
  • Prepare material for and participate in proposal pricing, stage gate reviews etc.
  • When Fujifilm is selected for a program, work with the program management group to help develop the Scope of Work from the proposal.
  • Proactively engage with the commercial, Process Development and manufacturing teams to refine Fujifilm’s technical advanced therapy product offering to better match of customer requirements (including price)
  • Through technical networking and participation at trade shows and conferences, promote Fujifilm particularly as a leader in advanced therapy product manufacturing

 

ORGANIZATIONAL STRUCTURE:

Job holder will report to Senior Director, Program Design, in turn reporting to Chief Scientific Officer.

 

SCOPE MEASURES:

  • The job holder may have line management responsibility for 1-3 direct reports within the Program Design team.
  • Advanced therapy is the key area for Fujifilm Diosynth future growth and expansion.  The job holder will be supporting around 50 opportunities a year each ranging in value from <$1M to >$10M.

 

BACKGROUND REQUIREMENTS:

  • The role requires a degree and post graduate qualification (preferably Ph.D.) in a relevant biological science with emphasis on a gene therapy, cell therapy, or viral background;
  • expertise in viral, microbial and cell culture process development and manufacture preferably in a CMO setting;
  • experience supporting a commercial/ sales team and an ability to analyze complex technical problems and present clear and concise solutions.
  • It is expected that the job holder will be based in the United States and will travel as required to support opportunities in all regions, with an emphasis on advanced therapy opportunities and the FDBT site in College Station, Texas. In addition it is expected that the job holder will travel to other Fujifilm Diosynth locations approximately 4-6 times each year.
  • The role requires the ability to work with and influence people in many different functions (PD, commercial, finance) including members of the Senior Leadership Team

 

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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