Lead GMP Facility Coordinator

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

 

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

 

Join us

 

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 state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

About This Role

 

The Lead GMP & Facility Coordinator is responsible for the implementation and direct oversight of all facility driven current Good Manufacturing Practices (cGMP) support processes. This role is expected to own an effective, preventive, and predictive cGMP support program and execute those duties professionally, using human performance tools, safe work practices, and adherence to procedure use.

External US

What You’ll Do 

• Serves as the Subject Matter Expert (SME) for all facility related GMP support processes, including but not limited to gowning, pest control, cleaning, and waste removal
• Manages and provides direction to the GMP contract vendors while ensuring operational protocols are properly executed
• Escalates deficiencies and major issues to management or necessary stakeholders
• Creates and develops initial standard operating procedures (SOPs) and policies and revises, as needed to support business operations
• Oversees the facility specific Food & Drug Administration (FDA) audit documentation retention and inspection processes
• Reviews the facility GMP budget and provides recommendations to management for cost saving initiatives, contract improvements, etc.
• Participates in the opening meeting for GMP audits, as directed
• Collaborates with other departments, such as Environmental, Health & Safety, Quality, etc.
• Other duties, as assigned

Who You Are

 

You will serve as the SME for all facility related GMP support and work closely with other departments.

 

Basic Requirements

• High School Diploma/GED
• 6+ years of GMP Facilities or Manufacturing work experience
• Proficient knowledge of computer software (e.g., Microsoft PowerPoint, Excel, Word, Teams, Adobe, etc.)
• Strong knowledge of building codes and regulations, including FDA cGMP requirements
• Strong knowledge of HVAC, plumbing, and electrical systems, including automation and controls
• Ability to influence and mentor others
• Ability to develop and implement sustainable and disaster preparedness initiatives
• Proficient technical writing skills
• Ability to work in an environment where all processes are not fully defined and support their development

 Preferred Requirements

• Bachelor’s degree in GMP Facilities Management, Maintenance, or related field
• Experience developing and managing budgets and capital projects

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Ability to ascend or descend ladders, scaffolding, ramps, etc

Ability to stand for prolonged periods of time

Ability to sit for prolonged periods of time

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers

Ability to operate machinery and/or power tools

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. 

 

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. exp