Supervisor, QC Chemistry

Position Overview

The Supervisor, QC Chemistry, first shift is responsible for day-to-day supervision, audit readiness, and planning activities for the Chemistry laboratory. This Supervisor will lead a team responsible for performing routine testing of QC analytical chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, peptide mapping, and physical appearance.

FUJIFILM 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.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit:

What You’ll Do

• Provide supervision and manage scheduling of the QC Chemistry team to ensure testing timelines are achieved.
• Ensure analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.
• Perform, review, and provide expertise in physical and chemical analytical testing methods, including chromatography (HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis, ELSD), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, peptide mapping, and physical appearance per Standard Operating Procedures (SOPs) and test methods.
• Act as primary point of contact for the team and first-line escalation.
• Lead the team to meet project deliverables.
• Set up and maintain operations of a QC testing laboratory.
• Review and approve SOPs, protocols, reports, change controls, Track Wise deviations, out-of-specification (OOS) and out-of-trend (OOT) investigations, and CAPAs for the QC Chemistry team, as needed.
• Assist senior management with resource planning and budget-related tasks.
• Gather recommendations for enhancements and gaps; collaborate with leadership to prioritize and implement solutions.
• Liaise with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results, as needed.
• Participate in cross-functional collaborations with other QC Departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Allocate and plan adequate resources for laboratory testing activities and QA support; provide technical guidance to the team.
• Lead cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-sized approach.
• Lead or guide laboratory staff in investigating deviations/excursions and implementing CAPAs as needed.
• Serve as SME in audits and inspections; prepare and guide the laboratory team to ensure audit readiness.
• Collaborate with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements.
• Establish and maintain internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements.
• Provide training, coaching, and mentorship; identify areas for improvement, reduce blind spots, and create growth opportunities aligned to career objectives.
• Perform other duties, as assigned.

Minimum Qualifications

• Bachelor’s in Chemistry, Biochemistry, Biological Sciences, or related science field…