QC Chemistry 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.

Company Overview

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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, TrackWise 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 with 5+ years of experience; OR,
• Master’s in Chemistry, Biochemistry, Biological Sciences, or related science field with 3+ years of experience.
• 2+ years of team management experience.
• Analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO).
• 3+ years of experience working in a regulated GMP environment.
• Ability to guide and influence teams in a laboratory setting.
• Excellent oral and written communication skills.
• Experience in large pharma/biotech operations or projects.
• Knowledge and experience of physical and chemical analytical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LCMS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, peptide mapping, and physical appearance.
• Proven ability to lead teams.

Preferred Qualifications

• Experience managing complex projects.
• Experience with customer relationship management.
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting.
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system).
• Working knowledge of LIMS, Smartsheet, TrackWise, and/or Kneat validation software.
• Experience and high-level familiarity/understanding of laboratory equipment, utilities qualification, environmental monitoring qualification, quality systems, automation, IT systems, and/or method validation.
• Experience in and thorough understanding of Data Integrity and application of regulatory requirements for QC assays.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job,the employee is required on a regular basis to:

• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 240 minutes.
• Ability to sit for prolonged periods of time up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, and reach to retrieve materials from 18” to 60” in height, and use twisting motions.
• Will work in warm/cold environments.
• Will work in small and/or enclosed spaces.

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.

*LI-Onsite

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).