Senior Analyst 1, QC Analytical Development - Chemistry (Holly Springs)
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. 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 in Microsoft Office products (Outlook, Word, Excel, and Power Point). Ability to work with minimal supervision. Ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships. Excellent verbal and written communication skills and attention to detail. Thorough understanding of pharmaceutical/biotech testing. Proven ability to conduct investigations, writing deviations and CAPA’s. Superior technical writing and problem-solving skills required. Must be flexible to support 24/7 manufacturing facility. Minimum Qualifications B.A./B.S. degree in Chemistry, Biology, Microbiology, Biochemistry or other relevant scientific discipline with 2 years of experience; OR, Masters degree in biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0 years’ experience. 3 years laboratory experience. 1-3 years GMP laboratory experience. Experience in a GMP environment. Experience with physical and chemical analytical testing 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. with cellular and molecular analytical testing methods.
