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Form of workJob Description
Our client is a leading biotechnology company that discovers, develops, manufactures, and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.
Job Overview:
This position is part of the Small-Molecule Impurities Group in the Protein Analytical Chemistry department responsible for analyzing and managing small-molecule impurities to support process development and validation activities. This group 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 leachables (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.
