Head of Process Development, Viral Gene Therapy

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.

This position will sit in Boston, MA. 

External US

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

Essential Functions

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, organisation 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 standardising operations, procedure 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.

Turnover          

Growing to $45M in 5 years

Site Numbers

Growing to 90 FTEs

Number of Customer projects

Growing to 15 program starts per year

Forward work plan

Up to 36 months

Minimum Qualifications:

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. 

Preferred Qualifications

Matrix management experience.

Previous experience in a Contract Manufacturing Organization (CMO) 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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.