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Project Director: Head of ENG/Project Delivery in Holly Springs, North Carolina | Careers at NC Holly Springs FDBU Office more...
Location:Holly Springs, NC
Company:FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
First posted:March 25, 2021 (last updated 1 day 22 hours ago)
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Requisition ID 2021-14701
Category Project Management
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
External US

The Production Director: Head of ENG/Project delivery will be responsible for the establishment of the entire production facility covering DSM, DP and FGM in the Project.

The project will - during phase 1 in the years 2021-2025 - invest more than $2b and recruit more than 725 employees to establish end to end manufacturing capacity and enable delivery of life saving medicine, hereunder among other things Covid-19 vaccines.

The Manufacturing plant is expected to deliver products from 2025 and forward and most likely phase 2 (larger than phase 1) is currently expected to be kicked off.

The project director is the leader in establishment of the facility with responsibility of getting the facility ready with all relevant aspects (process equipment, buildings etc.), on time in the right quality. You will with your experience from establishing production facilities in a cGMP environment, lead the project and direct a large team in the work packages in the project. You will be responsible for securing the facility are structured, designed, engineered, and constructed in a way that lives up to the expectation of future operations.

The position will oversee all engineering areas and collaborate closely with internal (FUJIFILM, FUJIFILM Diosynth Biotechnologies global) as well as external (local, regional and federal level and suppliers) stakeholders.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Build and lead the full establishment of the production facility - as the Project Director: 40%

Oversee all aspects of the establishment of the production facility Drug Substance Manufacturing (DSM), Drug products (DP) & Finish good manufacturing (FGM) or secondary buildings (CUB/WH, admin/lab)

Provide Leadership to Engineering areas: 35%

Leadership of engineering areas such as DSM (Drug substance Manufacturing), DP (Drug products) & FGM (Finish goods manufacturing), IT & Automation, CUB/WH/Admin (Central utility buildings), Engineering management, Project services and CQV (Commissioning, Qualification & validation)

Manage internal and external stakeholders as well as strategic objectives: 25%

Collaborate globally and globally to ensure project success as well as with internal and external stakeholders to ensure strategic objectives

REQUIREMENTS:

  • Master's Degree in Physical, Chemical or Biological Science, Technical Engineering or equivalent
  • More than 20 years of relevant global experience (industry as well as functional) and more than 15 years of consecutive leadership experience, hereunder senior leadership experience. Moreover experience from involvement in large (up to $2b) projects. In specifically:
  • Global expertise includes senior leadership experience from a similar project in Europe, North America & Asia.
  • Industry experience includes pharmaceutical experience as well as biopharmaceutical experience and Drug Substance, Drug Product and Finished Goods Experience. Market Cap top 10 Pharma experience highly preferred (ie abilit to help grow the company in a sustainable way).
  • Functional experience includes oversight of functions such as DSM, DP & FGM
  • Large project leadership experience includes involvement in expansion, projects establishing new capacity, establishing greenfield manufacturing facilities

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.

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.

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