• Responsibilities:o Routine testing with HPLC, Ultraviolet – Visible spectroscopy (UV-Vis), Total Organic Carbon (TOC), polarography, wet chemistry Raw Material, In-process, Final Product Release.o Author and investigate investigations and deviations. o Authored and executed technical reports for: New instrumentation installation qualification, operational qualification, and performance verification.  Current instrument annual requalification.  Compendial review of methods against USP/NF and ACS. Coordinate reference standard program o Ensure compendial reference standards were within expiry per USP o Qualify and requalify non-compendial reference standards per ICH guidelines. Spreadsheet validation. o Method validation and method transfer from development to QC.

• Responsible for High Performance Liquid Chromatography (HPLC) analysis of in process and finished drugs.o Gel permeation (size exclusion and iron exchange) chromatography (multiple product testing) .o Operation, analysis, trouble-shooting, and preventive maintenance.o Agilent Systems and Millennium Software.• Responsible for Gas Chromatography (GC) analysis of in process and finished drugs.• Responsible for Bench-top (fast through-put) Assays analysis of in process and finished drugs.o A280 protein concentration, pH Assay, p-NP Activity Assays, UV/Vis Spectroscopy Protein Concentration Assays, Appearance Assay, Reconstitution Assay (multiple product testing).• Preparation of samples, mobile phases, and reagents for assay performance.• Follow accurate written procedures for testing of in-process and finished drugs.• Review of Quality Control Data for compliance to procedures and specifications. Calculate and evaluate results.• Experience using iLIMS for reporting results and archiving data to customer and management.• Daily monitor and record all incubators, cold room temperature and laboratory hoods humidity.• Effectively demonstrate an understanding cGMPs and application to specification responsibilities. • Give feedback and training for new hire employee.

• Responsible for electrophoresis and HPLC analysis of in process and finished drugs.• Perform many chemical and physical tests under the company strict SOPs.• Documentation of test procedures into laboratory notebook per cGMP requirements.• Dealt with hazardous material and disposed of them accordingly.• Person in-charge for lab test scheduling and personnel assignment.• Hands on laboratory automation systems.• Mentored new lab members.• Follow cGMP guidelines monitored by internal and FDA auditors.• Hands on laboratory automation systems.