Key ResponsibilitiesProcess Development:Design and execute multi-step organic synthesis experiments to develop new and innovative routes for API synthesis.Conduct literature searches and patent reviews to identify non-infringing and commercially viable synthesis routes.Optimize reaction parameters such as temperature, pressure, time, and solvent to improve yield, purity, and reduce costs.Technology Transfer:Prepare and document process development reports and technology transfer documents (TTDs) for seamless scale-up.Collaborate with pilot plant and manufacturing teams to successfully transfer developed processes.Provide technical support and troubleshoot issues during scale-up and commercial production batches.Analytical and Data Management:Utilize and interpret analytical data from instruments like HPLC, GC, NMR, Mass Spectrometry, and IR to monitor reactions and characterize products.Ensure all experimental data and observations are meticulously recorded in a laboratory notebook, maintaining Good Laboratory Practices (GLP).Compile stability data and other technical documents required for regulatory filings (e.g., Drug Master Files or DMFs).Impurity Profiling:Identify, synthesize, and characterize impurities and degradation products to ensure product quality and regulatory compliance.Conduct forced degradation studies to understand the stability profile of APIs.Collaboration & Communication:Work closely with cross-functional teams including Analytical R&D (AR&D), Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs.Communicate project progress, challenges, and results to the R&D Manager and other stakeholders.Mentor junior team members and contribute to a positive and collaborative work environment.Safety & Compliance:Adhere to all safety protocols and company policies, especially when handling hazardous or sensitive chemicals.Maintain a clean and organized work area and ensure proper maintenance and calibration of laboratory equipment.Stay updated on the latest regulatory guidelines and industry trends.
