Senior Analyst 1, QC Chemistry

About the role

The Senior Analyst 1, QC Chemistry 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 role adheres to GMP-compliant laboratory operations in accordance with regulatory guidelines.

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).
• Captures 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 Biotechnologies objectives.
• Performs other duties, as assigned.

Requirements

• Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3+ years of experience
• 1- 3 years 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 CESDS, imaged capillary isoelectric focusing (icIEF)), wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc.
• Experience with cellular and molecular analytical testing methods

Qualifications

• Bachelor’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field
• Master’s Degree in Chemistry, Biochemistry, Biological Sciences, Engineering, or related science field
• 1+ years of experience with Raw Material methodology as it pertains to cGMP
• Experience with LIMS software

Physical Requirements

• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to sit for prolonged periods of time up to 240 minutes
• Ability to conduct activities using repetitive motions that include wrist, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
• Ability to bend, push or pull, and reach to retrieve materials from 18” to 60” in height, and use twisting motions
• Will work in warm/cold environments
• Will work in small and/or enclosed spaces