Scientist 2, QC Chemistry

Fujifilm•Holly Springs, NC

5d•Onsite

About The Position

The Scientist 2, QC Chemistry is a technical subject matter expert (SME) 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 2, 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). The QC Chemistry Scientist II authors, reviews, and approves SOPs, protocols, and technical reports. The role serves as the subject matter expert (SME) for QC Chemistry in cross-functional projects and meetings. 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

Requirements

Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 8+ years of relevant experience; OR, Master’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6+ years of relevant experience; OR, D. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 4+ years of relevant experience.
4+ years of experience working in a regulated GMP environment.
In-depth technical knowledge and experience of 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.
Advanced knowledge and experience of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to Chemistry analytical methods.
Familiarity with LIMS Software.
Ability to independently analyze raw data and assess assay and system suitability criteria.
Displays an advanced knowledge of GMP requirements for laboratory operations.
Demonstrated complex problem-solving skills.
Excellent organization and analytical skills.
Excellent technical writing, presentation, and communication skills.
Excellent interpersonal skills including the ability to work as part of a cross-functional team, collaborate with external clients, adapt to changing business needs, communicate with confidence, challenge others when necessary and display strong problem-solving capabilities.
Ability to plan, prioritize and to complete own work and the work of others.
Excellent English oral and written communication skills as well as demonstrated expertise with Microsoft Excel, Project, Word and SmartSheet.

Nice To Haves

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.

Responsibilities

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.
Represents QC Chemistry in cross-functional collaborations with other QC Departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objective.
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.
Authors technically-sound simple to moderately complex reports with limited guidance.
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.