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Senior Analytical Chemist
2 months ago
The Senior Analytical Chemist will work 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 will adhere to GMP-compliant laboratory operations in accordance with regulatory guidelines.
Key Responsibilities- Execute 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.
- Ensure analytical testing of in-process, drug substance (DS), drug product (DP), and stability samples is performed according to appropriate GMP regulations.
- Ensure analytical testing data is captured in LIMS software and data integrity is maintained.
- Report assay performance and assist with implementing improvements that ensure quality and efficiency within QC Chemistry.
- Identify and follow up on excursions and deviations and initiate corrective and preventative actions (CAPAs).
- Coordinate and support QC Chemistry lab activities as needed.
- Provide training for QC Chemistry lab associates.
- Author and review SOPs and technical reports.
- Work cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Diosynth Biotechnologies objectives.
- 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.
