Single Point of Contact overseeing the manufacturing process throughout the commercial lifecycle, ensuring product quality and process robustness.Proficient in process safety, hazardous reaction management, HAZOP studies, scale-up, and tech transfer.Collaborate with external suppliers to enhance process capability and maintain validation.Analyze manufacturing data from APQRs and relevant sources for control assessment.Lead/support root cause investigations for product and process failures, collaborating across teams.Proficient in hands-on characterization using analytical techniques like MS, NMR, HPLC, XRD, IR.Develop cost-effective non-infringing processes for API and intermediates.Improve yield and quality of intermediates and APIs.Evaluate impact of technical changes, assess feasibility of technical batches, and contribute to registration strategies.Ensure continuous validation oversight, review control strategies, and Quality Risk Analyses.Verify critical process parameters through thorough testing of technical batches.Support evaluation and selection of external suppliers and product transfers.Support regulatory activities for new product submissions to EDQM, WHO, US, and JP.Support regulatory activities for DMF filing, including carryover study, genotoxic impurity assessment using QSAR, justification for impurity and intermediates through purge and fate analysis, evaluation of elemental impurities, assessment of nitrosamine impurities, and Quality Risk Assessment (QRA) study utilizing Design of Experiments (DOE) conceptAid in regulatory activities for new product submissions and DMF filings.Expertise in hazard assessment using ICH M7 guidelines.Lead nitrosamine impurity assessment and control strategy