Scientist 1, QC Chemistry

Position Overview

About the Role

 

The Scientist 1, QC Chemistry is responsible for QC analytical chemistry methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Scientist 1, QC Chemistry ensures GMP-compliant laboratory operations in accordance with regulatory guidelines. This role performs technical/compliance reviews and approves analytical results. The role approves laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs).

Company Overview

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.

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

 

• Performs physical and chemical analytical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, UV-Vis, FTIR), electrophoresis (GE, non-reducing and reducing CE-SDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance• Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations• Performs laboratory work and peer reviews of analytical data in support of tech transfer and routine manufacturing• Executes and reviews method qualification and validation activities and maintains lab equipment• Monitors assay performance and implements improvements that ensure quality and efficiency within QC Chemistry• Troubleshoots and investigates deviations and invalid assays performed in QC Chemistry• Authors, reviews, and approves 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• Participates in cross-functional collaborations with other QC Departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives• Manages and monitors lab activities, as needed• Provides training for QC Chemistry associates• Provides technical support as the QC Chemistry SME during customer visits, audits, and regulatory inspections• Participates in risk and gap assessments during project scoping, as needed• Collaborates with the LIMS team and IT department to build new method functionality that meets end-user and customer requirements• Liaises with Contract Laboratory Organizations (CLOs) to monitor method execution and the timely delivery of results, as needed• Executes routine analytical methods and trains other QC Chemistry laboratory associates• Performs other duties, as assigned

 

Minimum Requirements:

 

• B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 5+ years of experience OR• M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience, OR

• Ph.D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of 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• Knowledge and experience of physical and chemical analytical testing methods for biological products, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/M