Familiar with HPLC & GC operations & troubleshooting
Familiar 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.
Other duties assigned by manager
Other 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
