QC Manager, Bioassay at FUJIFILM Holdings America Corporation

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.

External US

About This Role

The Manager, QC Bioassay oversees key functional and operational aspects of the QC group, ensuring GMP-compliant laboratory operations. This role manages and supervises the Bioassay team, which conducts cell-based and plate-based methods, including protein binding assays, potency assays, cell culture maintenance, and residual testing for DNA, Host Cell Protein (HCP), and Protein A/G. As a technical subject matter expert, the Manager provides support for troubleshooting complex investigations and optimizing laboratory systems. This role ensures compliance with GMP standards, maintain accurate documentation, and lead day-to-day team activities. Additionally, the Manager represents QC Bioassay during customer and regulatory audits while fostering team development through effective leadership

What You’ll Do

Basic Requirements

Preferred Requirements

Prior experience and advanced knowledge of QC testing involving: ELISAs, Potency assays, residual DNA/Host Cell Protein/Protein A assays.

Working Conditions & Physical Requirements

Ability to sit for prolonged periods of time. 

Ability to stand for prolonged periods of time. 

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

Ability to conduct work that includes moving objects up to 10 pounds.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

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

Will work in warm/cold environments 2‐8C, ‐20 and ‐70C temperature for a few mins with appropriate PPE

Will work in heights greater than 4 feet.

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 

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.