Job description
The Research Chemist will be responsible for developing and validating methods, as well as performing stability assessments on drug substances and products. This role includes assisting with Out of Specification (OOS) investigations, Corrective and Preventive Actions (CAPA), and preparing regulatory submissions, all while ensuring the accuracy of laboratory documentation. Proficiency in analytical methodologies including GC, LC-MS, and HPLC is essential. Candidates should also have experience with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and FDA regulatory standards.
