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, 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

• Manages and prioritizes daily activities of QC Bioassay with team planners, focusing on release, stability, and clinical testing while ensuring overall performance according to KPIs and delivering results within expected turnaround times.
• Ensures timely analysis, review, and approval of results to support on-time CoA issuance or stability time points and approves data reports within the team’s area of discipline.
• Oversees laboratory exceptions and investigations, ensuring timely closure according to Quality metrics, while managing complex issues and barriers to support team success.
• Motivates the group to perform efficiently, reducing turnaround times for the release of commercial, stability, and clinical products.
• Manages and prioritizes the preparation of procedures, protocols, and associated reports for various deliverables while ensuring compliance with
GMP guidelines.
• Leads projects such as method transfers and qualifications to support new product introductions for new and existing customers, while focusing on optimized laboratory systems and implementing necessary procedural changes.
• Directs a team responsible for executing bioanalytical methods requiring aseptic techniques for cell culture maintenance and cell-based assay execution.
• Leads method verification, qualification, and validation activities while maintaining lab equipment, and authors, reviews, and approves SOPs, protocols, reports, change management reports, Trackwise deviations, and investigations as needed.
• Ensures department readiness for customer visits, audits, and regulatory inspections while providing technical leadership through effective project
management and status tracking.
• Proactively identifies technical gaps and areas for improvement related to quality and represents QC Bioassay on cross-functional Tech Transfer teams to support implementation and validation of client methods.
• Provides leadership and mentoring to aid in team development while supporting management in compliance-related activities.
• Manages complex problem-solving efforts that may impact compliance of methods, results, products, or Quality systems, making decisions in consultation with management as necessary.
• Performs other duties as assigned.

Basic Requirements

• Bachelor’s degree with 8+ years of experience in a GMP environment
OR
• Master’s degree or Ph.D. in Chemistry, Microbiology, Biological
Sciences, Engineering or related science degree with 6+ years of
GMP experience OR

• Ph.D. in Chemistry, Microbiology, Biological Sciences with 4+ years
of GMP experience
• 2- 3 years QC Bioassay leadership experience
• Prior experience and advanced knowledge in Bioassay testing
• Prior Experience and Advanced knowledge working with BSL1 and BSL2 viruses in a GMP lab environment including mammalian cell culture propagation and maintenance

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 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.