Head of Drug Substance Manufacturing

We are looking for a Senior Leadership team member who will join as Head of Drug Substance Manufacturing (DSM) on our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of DSM, you will be responsible for the establishment of a new production facility in a $2 billion global project.

You will be responsible for heading up and setting the direction for the Drug Substance Manufacturing part of the project. As a senior member of the leadership team at the new site, you will play a major part in setting strategic leadership direction for FDB globally and contribute to new standards within our area.

We are looking for a senior leader with over 20+ years of experience in Pharma/ Biotech projects and/or Operations who can leverage existing experience from strategic and tactical roles and guide cross-functional team members on the journey.

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 Senior Leadership team member who will join as Head of Drug Substance Manufacturing (DSM) on our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Head of DSM, you will be responsible for the establishment of a new production facility in a $2 billion global project.

You will be responsible for heading up and setting the direction for the Drug Substance Manufacturing part of the project. As a senior member of the leadership team at the new site, you will play a major part in setting strategic leadership direction for FDB globally and contribute to new standards within our area.

We are looking for a senior leader with over 20+ years of experience in Pharma/ Biotech projects and/or Operations who can leverage existing experience from strategic and tactical roles 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

• Build and lead the full establishment of the production facility.
• Assume overall budget responsibilities for the project. 
• Gradually build the drug substance manufacturing organization and secure robust ramp-up for manufacturing.
• Ensure 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 drug substance manufacturing across support functions and 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.
• Member of Senior Leadership team for the site.
• 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's or Master's Degree in Physical, Chemical or Biological Science, Technical Engineering or equivalent
• 20+ years' experience from similar role in large pharma/biotech projects.
• 10+ years of experience within team management.
• Experience of establishing production facilities in a cGMP environment
• Process knowledge for the specific area of DSM
• Experience in a cGMP facility or working with FDA regulations.
• Good communication skills and fluency in English

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.

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.