Head of Product Supply

We are looking for a Head of Product Supply to join our senior leadership team and help guide our journey to establishing the largest end-to-end cell culture CDMO facility in North America.  As Head of Product Supply, you will lead the Drugs Substance Manufacturing, Drug Product & Finished Goods Manufacturing and Supply Chain groups within the new production facility.  This is a unique opportunity to build something that has never been built before.  You will set the direction for the manufacturing part of a $2B project and play a major role in setting the strategic leadership direction for Fujifilm Diosynth Biotechnologies globally.  You will leverage your experience and knowledge within large-scale manufacturing of biologics, packaging, and supply chain management to create new standards in our organization. 

External US

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new site is to be located in Holly Springs, North Carolina, United States. 

We are looking for a site senior leadership team member who will join as Head of Product Supplyon our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of Product Supply, you will be responsible for Drugs Substance Manufacturing, Drug Product & Finished Goods Manufacturing and Supply Chain within the new production facility.

You will be responsible for heading up and setting the direction for the manufacturing part of the project. As Head of Product Supply, you will play a major part in setting strategic leadership direction for FDB globally and contribute to new standards within our area by leveraging existing experience within large-scale manufacturing of biologics, medical device assembly, packaging and supply chain management.

Additionally, you will be responsible for establishing Manufacturing strategies and goals as well as the development and implementation of new processes and procedures. The position interfaces with cross functional facility heads to oversee activities for manufacturing areas such as validation, maintenance, calibrations, up-grades, sampling, and others. 

We are looking for a senior leader with over 12+ years of experience in Pharma/ Biotech projects and/or Operations who can leverage existing experience from strategic and tactical roles within manufacturing and guide cross-functional team members on the journey.

You will join an organization focusing on growth, people and a steep learning curve as well as a diverse workplace with people driven to make a difference.

Job Responsibilities

• Establish Manufacturing strategies, goals, and processes
• Drive the relevant Manufacturing activities to ensure achievement of the business
• Ensure harmonization of practices across manufacturing
• Gradually build the Manufacturing organization to secure robust ramp-up
• Overseeing and securing compliance with all standards and directives
• Member of Senior Leadership team for the site.
• Hire staff and develop high performance culture and organizational training management
• Support the development of the new facility from a Manufacturing point of view ensuring that the facility is completed to a consistently high standard, within budget, and that objectives are met on time, suiting the company's vision and objectives.
• Ensure operational readiness for manufacturing
• Lead the activities in collaboration with other facility owners across the project.
• Prepares and presents project status and targets.   
• Coordination with external partners e.g., on deliverables and schedule 
• Manage proposed changes within project.   
• Vendor management.
• Ensure project implementation is well received throughout the organization.
• Secure resources in the project organization to support and deliver progress.  

Requirements

We are looking for a candidate with the following background and skill set:

• Bachelor or Master in Physical, Chemical or Biological Science, Technical Engineering or equivalent
• 12+ years of experience from a similar role in large pharma/biotech projects.
• 10+ years of experience within people/ team management.
• Experience in establishing production facilities in a GMP environment
• Experience in Manufacturing, Product Supply and/or Supply Chain
• Experience in a GMP facility or working with FDA regulations.
• Demonstrate excellent verbal and written communication English skills, and exceptional interpersonal skills.

The Company requires that the successful candidate hired for this position be fully vaccinated for COVID-19, absent being granted an accommodation due to medical, pregnancy, or sincerely held religious belief or other legally required exemption.

FDBN 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.

FDBN 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. If an accommodation to the application process is needed, please email lena.lee@fujifilm.com.

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 wll be paid.