Manager, QC Lab Support

Location: Holly Springs
Posted on: June 23, 2025

Job Description:

FUJIFILM Diosynth Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. What Youll Do • Leads all areas of QC Lab Support (e.g., change controls, investigations, corrective action preventive action (CAPAs), data review, etc.) • Develops QC Lab Support goals and strategy in alignment with the production schedule • Drives Quality Control key performance indicators (KPIs) to support quality, continuous improvement, while escalating and mitigating issues • Oversees training and development for all QC Lab Support staff • Ownership and oversite of QC systems and business processes • Interacts professionally with clients and partners to effectively communicate QC deliverables and commitments • Leads discussions and responses during inspections, including area readiness prior to these inspections • Drives and supports alignment and coordination between other FDB sites on QC topics • Manages and develops direct reports from the Lab Support team • Administers company policies such as time off, shift work, and inclement weather that directly impact employees • Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.) • Coaches and guides direct reports to foster professional development • Participates in the recruitment process and retention strategies to attract and retain talent, as needed • Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution • Performs other duties, as assigned Minimum Requirements: • Bachelor’s degree in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 7 years of experience OR • Masters degree in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 5 years of experience OR • Ph.D. in Chemistry, Microbiology, Biological Sciences, Engineering or related science with 3 years of experience • 2-5 years of people management experience • Experience working in a regulated GMP environment • Experience managing and developing direct reports and teams • Extensive experience with Analytical and/or Microbiology methods Preferred Requirements: • 5 years of experience in a GMP environment • Experience working in a contract manufacturing or testing organization • Experience with statistical experimental design and data analysis with JMP software Physical and Work Environment Requirements: • Ability to discern audible cues. • Ability to stand for prolonged periods up to 240 minutes. • Ability to sit for prolonged periods up to 240 minutes. • Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. • Ability to conduct work that includes moving objects up to 10 • Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions pounds. • Will work in small and/or enclosed spaces.

Keywords: , Fayetteville , Manager, QC Lab Support, Science, Research & Development , Holly Springs, North Carolina