Director of Program Design, Gene Therapy

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 Director of Program Design will be an expert in viral-vectors and gene-therapy engaging potential clients in support of sales. They will author customer-tailored proposals and act as the technical advisor to management on the latest trends in viral vectors and gene therapy. The job holder will be responsible for providing technical support with an emphasis on viral-vectors and gene therapy with the focus on the potential customers located in the United States and the development and production capabilities of Fujifilm’s Texas site.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Act as the technical lead and expert during customer meetings and teleconferences
  • Prepare proposals in response to client’s RFPs
  • Match clients’ needs with Fujifilm’s capabilities and provide advice on the technology for process development, analytical testing and manufacturing.
  • Define program scope, siting/location, timelines and resources
  • Propose program pricing based on internal guidance and pricelists
  • Support development of detailed Scope of Work for converted opportunities
  • Work with the commercial, process development and manufacturing teams to refine Fujifilm’s technical offering
  • Support Business Development to spot and further develop expansion opportunities
  • Participate at trade shows and conferences as technical expert and a speaker

SCOPE MEASURES:

  • The job holder at the Director level may have line management responsibility for 1-3 direct reports.
  • 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 >$1OM.

BACKGROUND REQUIREMENTS:

  • A degree and post graduate qualification in a relevant biological science with emphasis on a gene therapy, cell therapy, or viral vectors/products;
  • Good understanding of the viral-vector and gene therapy fields, including expression platforms, vector types, and their applications
  • Understanding of regulatory environment, process development, and analytical technologies related to viral-vectors and gene-therapy
  • Expertise in at least one of the following: viral vector design, cell-culture-based viral production, viral-vector purification, or viral-vector analytical technology
  • Ability to analyze complex technical problems and present clear solutions
  • Ability to influence customers and colleagues at all levels (inclusive of CEO/President)
  • Prior experience within a CDMO a plus but not required.
  • Understanding of and experience with cGMP manufacturing a plus not required
  • The job holder will be based in the Southern United States, working either at the Fujifilm Texas sites or from a home office within the driving distance of the Texas site.
  • Travel (up to 30%) is required to support opportunities in all regions, with an emphasis on viral-vector and gene-therapy capabilities.

 

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.

Apply here