QC Senior Scientist, Testing

Job Summary:Perform testing in IPC, finished products testingFamiliar with HPLC & GC operations & troubleshootingFamiliar with CE-SDS, cIEF, cell based potency, ELISA based qualification, Karl Fischer Titrator, Total Organic Carbon (TOC) testing, UV-Vis Spectrophotometer machines, FTIR.Manage laboratory supplies, conduct inventory, and place orders for replacements as needed.Follow established safety protocols and regulations to maintain a clean, safe, and organized work environment.Provide guidance to the teamOther requirements:A good understanding of the overall view of drug development process.A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas.Comprehensive knowledge in IND/IMPD, NDA and ANDA filing