Senior Chemist
New Jersey, United States
■Experienced in analytical research, method development, and method validation (including method SOP writing, protocol SOP writing, protocol SOP execution, and report writing) under cGMP for various dosage forms including tablet, capsule, solution, and suspension■Solved the key research problem to identify and quantify a major unknown impurity of a major drug product in a three months time-frame using HPLC-CAD, leading to the successful approval of the drug product by the FDA ■Conducted root cause analysis,suggested remediation, and wrote investigation reports to address issues emerging from release testing in Quality Control■Developed a Standard Operating Procedures and Performance Qualification Protocol from scratch for a new piece of instrument ■Collaborated with a cross-functional team involving R&D, Quality Control, Product Development, Quality Assurance and Regulatory Affairs to accomplish five projects in one year■Experienced with USP monograph, ICH guidelines work knowledge and assisted RA on filling document