QC Scientist - HPLC

Job Description

You will perform HPLC/UPLC testing on various samples, including In-Process DS release, DP release, DS stability, DP Stability, process validation, analytical method validation/transfer, method establishment/qualification, and other non-routine samples. Responsibilities include demonstrating proper laboratory safety and housekeeping practices, conducting GMP testing using HPLC and UPLC methods, accurately recording and reporting analysis results, recognizing and reporting out-of-specification/out-of-trend results, maintaining and troubleshooting analytical instrumentation, performing method validation/qualification testing, authoring/reviewing SOPs and test methods, and collaborating with internal and external customers to maintain clear communication.

Skills

• Bachelor's degree in Chemistry, Biochemistry, or Biology
• 1 year of HPLC/UPLC experience
• Experience with HPLC/UPLC assays (SEC, CEX, Glycans, Peptide Map)
• Prior use of EMPOWER
• Knowledge of GMP regulations in cGMP manufacturing environment
• Working knowledge of scientific principles for a wide range of analytical techniques