Senior QC Chemistry Analyst

Position Overview As a Senior QC Chemistry Analyst, you will play a crucial role in our biopharmaceutical manufacturing processes by executing a variety of QC Analytical Chemistry methods. You will work independently to perform tests that encompass chromatography, spectroscopy, electrophoresis, and more, adhering to GMP-compliant laboratory operations in alignment with regulatory standards. This position is fundamental in generating analytical results while identifying laboratory exceptions, invalid assays, deviations, and corrective actions. Company Overview Join FUJIFILM Biotechnologies as we pave the way for innovation in bioproduction. By the end of 2025, we will establish North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility in Holly Springs, North Carolina, specializing in drug substance production, fill-finish, and packaging—all under one roof. We seek passionate and mission-driven individuals to help us deliver groundbreaking vaccines, cures, and therapies. Our dynamic work environment nurtures a culture of purpose and energy—what we call Genki. Are you ready to transform healthcare with us? Holly Springs, North Carolina, offers a unique blend of a close-knit community and access to the thriving tech scene in nearby Raleigh. What You'll Do Conduct analytical testing methods including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (MS, GC/MS, LC-MS/MS, UV, FTIR), electrophoresis, wet chemistry, glycan analysis, peptide mapping, and particle analysis. Ensure all analytical testing of samples—such as in-process, drug substance, drug product, and stability samples—follows GMP regulations. Utilize LIMS software to capture testing data and uphold data integrity. Report assay results and contribute to quality improvement initiatives within QC Chemistry. Identify and address departures from standard procedures by initiating corrective and preventive actions (CAPAs). Support and coordinate laboratory activities and provide training for new associates in QC Chemistry. Author and review Standard Operating Procedures (SOPs) and technical reports. Collaborate cross-functionally with departments such as Manufacturing, Process Science, and Quality Assurance to meet business objectives. Perform additional responsibilities as assigned. Minimum Qualifications Bachelor's Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or a related field with at least 3 years of laboratory experience. Minimum of 1-3 years working in a GMP-compliant laboratory. Hands-on experience with a variety of analytical testing methods relevant to biological products. Preferred Qualifications Master's Degree in a related scientific field. Experience with raw material methodologies in a cGMP environment. Proficiency with LIMS software. Physical Requirements: This position requires physical capabilities to effectively perform essential functions which include: Ability to discern audible cues and ensure visual acuity for accurate testing. Ability to stand or sit for extended periods (up to 240 minutes). Engage in repetitive motion for tasks requiring significant use of hands and wrists. Move objects weighing up to 10 pounds and reach for materials situated at various heights. Comfortable working in both warm and cool environments and in small spaces. If you need reasonable accommodation for the application or interview process, please reach out to our HR Department. Job Locations: US-NC-Holly Springs Posted Date: 1 month ago Requisition ID: 2025-36487 Category: Quality Control Company: FUJIFILM Biotechnologies Fujifilm is an equal opportunity employer committed to diversity and inclusion in the workplace.

Created: 2026-03-10