AGM- Research & Development

As an Assistant General Manager in Research & Development at an Indian Pharmaceutical MNC based in Thane, you will play a crucial role in leading the Analytical Method Validation team. Your responsibilities will include overseeing validation activities, ensuring regulatory compliance, driving quality and efficiency, and fostering collaboration with R&D, Regulatory, and Plant QA/QC teams. Key Responsibilities: - Provide leadership for analytical method validation (AMV) across multiple dosage forms. - Oversee RM and PM characterization in compliance with regulatory requirements. - Plan and manage validation projects adhering to international regulatory guidelines. - Act as an SME for analytical lifecycle management and lead interactions with regulatory authorities. - Review DMF documentation for outsourced APIs and define product specifications and analytical methods. - Ensure audit readiness, handle audit responses, and provide cross-functional support to various units. - Lead investigations for OOS/OOT results, manage change controls, deviations, and incidents. - Drive training, compliance, and capability-building initiatives within the team. - Ensure GLP compliance, efficient utilization of laboratory infrastructure, and collaboration with formulation leads. - Manage departmental budgeting, material planning, and implement process improvements for enhanced efficiency. Qualifications & Skills: - M. Pharm / M.Sc. / Ph.D. in Analytical Chemistry or related discipline. - Hands-on experience with analytical instrumentation like HPLC, GC, LC-MS, etc. - Knowledge of international regulatory guidelines, QMS principles, method validation, and GLP practices. - Demonstrated leadership skills with experience in managing scientific teams. - Strong communication, stakeholder management, and project execution abilities. - Analytical thinking, attention to detail, and ability to make data-driven decisions. In this role, you may need to work in shifts and travel to external manufacturing or R&D sites based on business requirements. If you meet the qualifications and are interested, you can share your CV at pooja.j@domniclewis.com.,