Research Associate

About This Role

This research associate role focuses on the analytical method development and feasibility activities for drug substances, drug products, and excipients. It involves executing regulatory query activities, performing RLD analysis, and generating Certificates of Analysis.

Responsibilities

• Execute analytical method development (Assay, Dissolution, Related substances, content, UOD, PSD) and analytical method feasibility activities of drug substance / drug product / excipients
• Execute activities related to regulatory queries and perform RLD analysis and COA generation
• Prepare assessment reports, method development reports, and method equivalency reports of drug product
• Perform qualification and calibration of analytical instruments like HPLC, IR and other standalone instruments (like water content, pH meter, balances etc.)
• Prepare protocols / reports / standard operating procedures and standard testing procedures
• Follow cGLP/cGMP compliance of the analytical laboratory, ensuring laboratory safety, good laboratory practices, good documentation practice in the lab and general cleanliness and training & development activities
• Monitor and support all method transfer related activities from ARD to the CMO locations
• Execute authorized to sign (as prepared by) for, Certificate of Analysis, Calibration record, Specification and Standard test procedure, Method Validation / transfer/Reverse Engineering / protocols and reports, Method equivalency report etc.

Requirements

• M. Pharm