This position is part of the Small-Molecule Impurities Group (SMIG) in the Protein Analytical Chemistry (Client) department responsible for analyzing and managing small-molecule impurities to support process development and validation activities.
The SMIG utilizes advanced analytical tools such as NMR, GC-MS, LC-MS, and ICP-MS to quantify process-related small-molecule impurities, identify unknown compounds of interest, investigate product quality issues, and conduct extractables and leachable (E&L) studies.
In this role, you will perform both wet chemistry and instrumental analysis to support the SMIG projects in a timely manner. You will be exposed to various aspects of small-molecule analysis in complex biological matrices.
Responsibilities:Process protein drug samples for instrumental analysis using extraction techniques such as liquid-liquid extraction; prepare standards and replicates; spike analytes.Run samples on LC-MS and/or GC-MS using existing methods or develop/optimize new methods; perform method validation following a protocol.Analyze data to quantify analytes and/or identify unknown compounds.Document results properly and author reports; communicate results to project teams.Help with building and maintaining an internal E&L database and library.Basic Qualifications:B.S./B.A. degree in chemistry, materials science or a relevant scientific discipline with 3+ years of experience.Good understanding of chromatography and mass spectrometry with 2+ years of hands-on experience.Demonstrated capability of performing wet chemistry procedures such as solution preparation, sample processing, and quantitative analysis.Strong troubleshooting and problem-solving ability.Preferred Qualifications:An advanced degree (M.S.) in analytical chemistry.Experience with E&L analysis or trace analysis.Hands-on experience with protein sample preparation, high-resolution mass spectrometry (HRMS) or analytical method development and validation using LC-MS or GC-MS.Organization and documentation skills in a regulated environment. •
Last updated on Nov 15, 2023