Head of Building Drug Product and Finished Goods Manufacturing

Location
Holly Springs, NC
Posted
Jul 19, 2021
Ref
2021-14661
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

We are seeking a Head of Building Drug Product and Finished Goods Manufacturing in our journey to establishing the largest End-to-End cell culture CDMO plant in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji film have ever entered. Be a part of the future. Today.

You as the Head of Building Drug Product and Finished Goods Manufacturing will be responsible for setting the direction and managing the engineering and construction activities for the new facilities in a $2 billion global project. We offer the possibility of creating and leading the CSA team, and you will act as the leader of the team and work package owner with your management skills strong CSA background. The focus of the job will be on either Drug products (DP), Drug substance manufacturing (DSM) or finish good manufacturing (FGM). You will be responsible for securing that the future buildings are structured, designed, engineered and constructed in a way that lives up to the expectations of future operations.

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 create 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 FDB 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 will be built within the vicinity of an existing Fujifilm site in the US. The position will ultimately sit in Holly Springs, NC, U.S.A, once the site is able to accommodate.

We are seeking a Head of Building Drug Product and Finished Goods Manufacturing in our journey to establishing the largest End-to-End cell culture CDMO plant in North America but more importantly, someone who wants to be a part of the largest growth journey that we in Fuji film have ever entered. Be a part of the future. Today.

You as the Head of Building Drug Product and Finished Goods Manufacturing will be responsible for setting the direction and managing the engineering and construction activities for the new facilities in a $2 billion global project. We offer the possibility of creating and leading the CSA team, and you will act as the leader of the team and work package owner with your management skills strong CSA background. The focus of the job will be on either Drug products (DP), Drug substance manufacturing (DSM) or finish good manufacturing (FGM). You will be responsible for securing that the future buildings are structured, designed, engineered and constructed in a way that lives up to the expectations of future operations.

 

We are looking for someone with positive energy, entrepreneurship and courage to empower and inspire others. You will join an organization with focus on growth, you will have a steep learning curve but most essential there is a focus on people first and what you can bring to the table. We have a diverse workplace with people driven to make a difference.

Job Responsibilities

  • Identify and onboard team members to the CSA (Civil, Structural, Architectural), Black utility, electrical and HVAC project team. 
  • Lead the CSA team – project manager for work package (DP, DSM or FGM)
  • Secure information flow between client and A&E provider (Architectural & engineering) provider, to align expectations.   
  • Secure client requirements are included into the CSA design packages. 
  • Secure the review and approval of submittals from the A&E in within the CSA design packages. 
  • Secure that review of the tendering packages is performed within the CSA disciplines. 
  • Assist site construction teams and project controls teams with respect to the CSA works ongoing on site. 
  • Secure resources in owner's organization to support the project and deliver needed inputs to secure progress.  
  • Report on KPIs to the senior project team 

Requirements

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

  • Bachelor or Master in Civil, Structural or Architectural, Technical Engineering or equivalent
  • 15 + years as a senior engineering working on large industrial projects.
  • 5+ Years with team management experience.
  • Process knowledge for the specific area (DSM, DP, FGM)
  • Experience in cGMP manufacturing facilities 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.