Senior Analyst , QC Analytical Development - Chemistry

The Senior Analyst 1, QC Analytical Development (AD) Chemistry works with limited direction to support the execution of analytical method transfers and validations for drug substance (DS) and drug product (DP) manufacturing into the Quality Control laboratories of FUJIFILM Biotechnologies Holly Springs. The analytical chemistry methods used in biological product manufacturing include chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.

The Senior Analyst 1, QC AD Chemistry adheres to GMP compliant laboratory operations in accordance with regulatory guidelines. This role executes analytical method transfers from clients and authors and reviews procedures, SOPs, and technical reports.

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

• Executes verification, transfer, and validation of analytical chemistry methods 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. with cellular and molecular analytical testing methods.
• Ensures compliance of analytical testing with appropriate GMP regulations.
• Participates in regular meetings for TT programs with cross-functional teams and key stakeholders.
• Authors and reviews SOPs, protocols, and technical reports.
• Works cross-functionally with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure transfer of non-compendial and compendial methods according to deadlines.
• Collaborates with the LIMS team and IT department to build new analytical method functionality that meets end-user and customer requirements.
• Ensures compendial method oversight and scientific guidelines (e.g. ICH, EMA, FDA, etc.).
• Supports regulatory requests and inspections.
• Supports the QC AD team to investigate any project challenges with necessary risk assessment tools and techniques, as needed.
• Supports best practices for TT and PPQ strategies globally, as required.
• Coordinates and supports QC AD Chemistry lab activities, as needed.
• Provides training for QC Chemistry lab associates.
• Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to physical and chemical analytical methods.
• Working knowledge and experience…