Area Manager Warehouse & QC Lab

Location
Holly Springs, NC
Posted
May 21, 2021
Ref
2021-15047
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time

We are looking for an Area Project Lead of Warehouse (WH) and Quality Control (QC) Admin Building, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Area Project Lead of WH and QC, you will be responsible for setting the direction and managing a central workstream in a $2 billion global project.

We offer the possibility of creating and leading two dedicated project teams focusing on building the optimal warehouse capabilities on a global scale and ensuring QC mechanisms are established to measure method performance.

As Area Project Lead of WH, you will be responsible for designing and building the warehouse to serve the purpose of future operations and eventually operate the warehouse managing sample handling, scaling, systems operations and capacity analysis etc.

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 an Area Project Lead of Warehouse (WH) and Quality Control (QC) Admin Building, who will join our journey to establish the largest end-to-end cell culture CDMO facility in North America. As Area Project Lead of WH and QC, you will be responsible for setting the direction and managing a central workstream in a $2 billion global project.

We offer the possibility of creating and leading two dedicated project teams focusing on building the optimal warehouse capabilities on a global scale and ensuring QC mechanisms are established to measure method performance.

 

As Area Project Lead of WH, you will be responsible for designing and building the warehouse to serve the purpose of future operations and eventually operate the warehouse managing sample handling, scaling, systems operations and capacity analysis etc.

As Area Project Lead of QC, you will be responsible for method validation, verification, equipment verification and all analytical techniques/ methods performed to ensure generation of precise and accuracy analytical data. Additionally, you will be responsible for the space planning and administrate areas.

We are looking for a manager with positive energy, entrepreneurship, and courage to empower and inspire others while utilize your extensive knowledge and knowhow. 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

  • Design and develop the optimal warehouse setup
  • Design and own the warehouse footprint and processes from receiving to shipping
  • Global warehouse space management
  • Lead the QC Laboratory to outstanding mechanism/ method establishment
  • Ensure optimal quality inspections (internal and external)
  • Build and lead the two teams acting as manager
  • Assume overall budget responsibilities for the work package  
  • Ensures on-time project deliverables 
  • Performance reporting to senior project team 
  • Ensure deliverables meet all quality and compliance standards  
  • Coordination with external partners e.g., on deliverables and schedule 
  • Manage proposed changes within work package   
  • Creation and approval of required documents including SOPs  
  • Ensure delivery and implementation of solutions which fulfils requirements and expectations by the end users 

Requirements

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

 

  • Degree in Physical, Chemical or Biological Science, Technical Engineering or equivalent  
  • 10+ years of experience from similar role in large projects from conceptual design phase to qualifications
  • 5+ years of with team management experience.
  • Process knowledge for the specific area (Drug Substance Manufacturing, Drug Product, Finish Goods Manufacturing)
  • 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.