Analyst 1, QC Chemistry

About the role

The Analyst 1, QC Chemistry works with 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 Analyst 1, QC Chemistry adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines and standard operating procedures. This role generates analytical results and identifies laboratory exceptions, invalid assays, deviations.

Responsibilities

• Executes physical and chemical analytical testing methods used in biological product manufacturing, including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis), electrophoresis (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 standard operating procedures.
• 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 excursions and deviations.
• Captures and coordinates QC Chemistry lab activities as needed.
• Works cross-functionally with other QC departments, Manufacturing, Process Science, and Quality Assurance stakeholders to achieve customer and FUJIFILM Biotechnologies objectives.
• Performs other duties, as assigned.

Requirements

• Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, or related science field with 1- 3 years relevant experience.
• 1+ years laboratory experience.
• 1-3 years GMP laboratory experience.
• Experience with physical and chemical analytical testing methods used in biological product manufacturing including spectroscopy (UV, UV-Vis, FTIR), wet chemistry, and physical appearance.
• Experience with physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis, FTIR), electrophoresis (non-reducing and reducing CESDS, 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.
• Experience with LIMS software.

Qualifications

• Minimum qualifications: Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, or related science field with 1- 3 years relevant experience.
• Preferred qualifications: Experience with physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis, FTIR), electrophoresis (non-reducing and reducing CESDS, 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.

Skills

• Physical and chemical analytical testing methods used in biological product manufacturing including chromatography (GC, HPLC, UPLC, SEC), spectroscopy (UV, UV-Vis, FTIR), electrophoresis (non-reducing and reducing CESDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.
• LIMS software proficiency.

Benefits

Not specified.

Pay

Not specified.

Schedule

Not specified.