QC Scientist - HPLC

Job Description

As a QC Scientist specializing in HPLC, you will perform HPLC/UPLC testing on In-Process Drug Substance (DS) release, Drug Product (DP) release, DS stability, DP Stability, process validation, analytical method validation/transfer, method establishment/qualification, and various other non-routine samples. You will demonstrate proper laboratory safety and housekeeping practices through weekly 5S Lab audits and monthly laboratory inspections, ensuring all activities meet EHS requirements. Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods such as Reverse Phase, SEC, Titer concentration, and CEX. #stlsci

Responsibilities

• Accurately record and report analysis results in accordance with lab procedures and quality systems.
• Recognize and report out-of-specification/out-of-trend results to laboratory management and recommend solutions.
• Maintain and troubleshoot analytical instrumentation and workspace as needed.
• Perform method validation and/or qualification testing as needed.
• Author and/or review SOPs, test methods, forms, and other documentation in the document management system eDMS.
• Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Work with internal and external customers to ensure clear and open communication when resolving and raising issues.
• Collaborate with QC leads, PMs, and clients to maintain good health of client programs.

Essential Skills

• Minimum of 1 year of HPLC/UPLC experience in quality/analytical/pharmaceutical industry or similar experience.
• Experience with a multitude of HPLC/UPLC assays is a plus, including SEC, CEX, Glycans, Peptide Map, etc.
• Prior use of EMPOWER is preferred.
• Knowledge of GMP regulations in cGMP manufacturing environment.
• Working knowledge of scientific principles for a wide range of analytical techniques is strongly preferred.