Head of Process Development - Viral Gene Therapy - Boston
As a leading global Contract Development and Manufacturing Organization, FDB continues to grow and further accelerate offerings in viral vectors and advanced therapies. We are looking for a people, business and technically savvy Head of Process Development, ready to embark on a new journey with us to build a new facility as well as to recruit and lead a high performing organization. The new facility will house experimental and analytical equipment for viral vector and advanced therapy process development, with contract manufacturing services for early phase clinical trials beginning at the site in Fall 2023.
A unique opportunity to build and lead a new state-of-the-art process development and manufacturing facility for viral vectors and advanced therapies in the greater-Boston area
The Site Head will provide strong scientific, business and administrative leadership to Viral Gene Therapy process development and early stage cGMP manufacturing group at the Boston site, setting annual goals and objectives and long range planning. The Site Head will provide high-level business strategy for the site, oversee the management of resources and coordinate activities across multiple departments to achieve business objectives and revenue goals. This individual will serve as the strategic leader and an advocate for the site to the Viral Gene Therapy leadership team and will work to enhance the existing and establish new collaborations within the academia, pharma and industry communities to perform cutting-edge research and innovation in the field of advanced therapies.
The job holder will build, inspire, lead, and manage Viral Gene Therapy process development and early stage cGMP manufacturing group at our Boston site.
- Lead the establishment of the facility and the team, including hiring of staff and capital deployment enabling a fully functional service offering from the Boston site
- Ensure competitive excellence in VGT process development and manufacturing science.
- Ensure the effective operation, organization, and delivery of site VGT business targets.
- Ensure the team works safely within FDB's EH&S policies
- Ensure the team operates within the FDB Quality Management System.
- Engage and align with the global FDB Viral Gene Therapy science and manufacturing communities, aligning and standardizing operations, procedures and customer experience where feasible.
- Contribute, support and collaborate with the Viral Gene Therapy Business Steering Group on behalf of the site
- Support the sales and marketing activities to attract secure, and retain client programs
- Develop and grow the technical contacts and relationship with the local community on behalf of FDB.
- Ph.D degree preferably in Chemistry, Biology, Life Sciences, or related field, with at least 12 years' GMP experience preferably in the pharmaceutical or biotechnology industry of which at least 5 years of management/supervisory experience OR;
- Master's degree in Chemistry, Biology, Life Sciences, or related field with at least 16 years' GMP experience preferably in the pharmaceutical or biotechnology industry of which at least 5 years of management/supervisory experience.
- Matrix management experience.
- Previous experience in a Contract Manufacturing Organization (CMO) environment
We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.