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 Manager, Documentation Management will be responsible for creating and leading the Manufacturing Support Documentation team and their associated activities to ensure compliant and reliable production.

What You'll Do

During Project Phase:

Provide oversight and lead operational readiness projects, including but not limited to: leading the creation of manufacturing documentation business processes, and transferring any applicable business processes from an existing large scale facility, to ensure GMP operational readiness.
• Lead, manage and build the support documentation team

In Operations:

• Manage, lead, and develop direct reports from the support manufacturing team while overseeing, organizing, and coordinating the workload of the manufacturing documentation team
• Provide oversight on the coordination of non-batch activities and collaborate cross functionally, including but not limited to:

• • Batch documentation and associated automation recipe
  • Document creation and project management of manufacturing changeover
  • Preventive maintenance plans (PMs)
  • Column packing documentation and project management

• Lead the creation and lifecycle management of manufacturing standard operating procedures (SOPs) and work instructions (WIs)
• Collaborate with Manufacturing, Process Science, Engineering, and other functional groups to transfer in new programs into the facility, including maintaining alignment with other large scale documentation teams
• Act as a functional manufacturing documentation lead for regulatory inspections and audits
• Perform other duties as assigned.

Who You Are

You have the ability to collaborate with manufacturing and other functional areas. You demonstrate strong organizational skills in addition to project management capabilities. You actively champion continuous improvement practices and ideas. You have an advanced understanding of good manufacturing practices, inspection requirements, safety and manufacturing operations. You have the ability to coach, lead and develop individual contributors. You have experience with regulatory inspections, investigations and change management.

Basic Requirements

• High School Diploma or GED with 10 years of related experience OR
• Bachelor's Degree with 6 years of related experience
• Prior experience managing, leading and developing people

Preferred Requirements

• Bachelor's degree (BA/BS) or master's degree with an emphasis in life science or engineering with 6-10 years of experience in pharmaceutical/biological manufacturing operations
• Previous experience leading others in a pharmaceutical/biological manufacturing facility
• Experience working in a changing, project driven organization
• Previous experience directly supporting manufacturing

FDBN 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. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.