Job
Description
Role & responsibilities To conduct research and development of Active Pharmaceutical Ingredients (APIs), focusing on process design, optimization, and scale-up for new and existing drug substances, ensuring quality, cost-effectiveness, and regulatory compliance. Preferred candidate profile Design, develop, and optimize synthetic routes for APIs, intermediates, and impurities. Perform literature surveys and use tools like SciFinder, Reaxys, and patents to develop synthetic strategies. Execute lab experiments for route scouting, optimization, and impurity profiling. Scale-up processes from lab to pilot scale, ensuring process robustness and reproducibility. Develop and validate analytical methods in collaboration with the analytical team. Prepare and review technical documents including lab notebooks, development reports, and tech transfer documents. Support technology transfer to pilot plants and manufacturing sites. Address regulatory requirements and provide documentation for DMF (Drug Master File) and regulatory submissions. Ensure adherence to GMP, EHS, and quality compliance standards during development activities. Key Skills & Competencies: Strong knowledge of synthetic organic chemistry and reaction mechanisms. Familiarity with regulatory and quality requirements in API manufacturing. Hands-on experience in process development, scale-up, and impurity profiling. Proficient in analytical techniques such as HPLC, GC, NMR, MS, etc. Good understanding of QbD, DoE, and risk assessment tools.
