Senior Analytical Chemist

4 days ago


Holly Springs, United States FUJIFILM Corporation Full time
About the Role

The Senior Analytical Chemist works with limited direction to execute QC analytical chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Senior Analytical Chemist adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations, change controls, and corrective and preventative actions (CAPAs). The role is primarily responsible for executing routine analytical methods in support of manufacturing, supporting laboratory execution of analytical method transfers and validations, and training other QC Chemistry laboratory associates. The ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success.

Key Responsibilities
  • Executes 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.
  • Ensures analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.
  • Ensures analytical testing data is captured in LIMS software and data integrity is maintained.
  • Reports assay performance and assists with implementing improvements that ensure quality and efficiency within QC Chemistry.
  • Identifies and follows up on excursions and deviations and initiates corrective and preventative actions (CAPAs).
  • Coordinates and supports QC Chemistry lab activities as needed.
  • Provides training for QC Chemistry lab associates.
  • Authors and reviews SOPs and technical reports.
  • Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives.
Requirements
  • B.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of relevant experience
  • 3+ years laboratory experience
  • 1-3 years GMP laboratory experience
  • 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.
Preferred Requirements
  • M.S. in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 1+ years of experience
  • Familiar with Raw Material methodology as it pertains to cGMP
  • Experience with LIMS software


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