Job
Description
We are looking for Assistant General Manager- Analytical Method Validation (Research & Development) for an Indian Pharmaceutical MNC based in Thane Position: Assistant General Manager- Analytical Method Validation (Research & Development) Experience: 15-20 years in Analytical Method Validation Qualification: M. Pharm / M.Sc. / Ph.D. in Analytical Chemistry Location: Thane, Maharashtra The Associate General Manager – AMV will be responsible for strategic and operational leadership of the Analytical Method Validation team, overseeing the execution of validation activities across multiple dosage forms. The role involves managing a team of 15+ scientists, ensuring regulatory compliance, driving quality and efficiency, and supporting cross-functional collaboration with R&D, Regulatory, and Plant QA/QC teams. Key Responsibilities Provide leadership and direction for analytical method validation (AMV) across oral solid, nasal, injectable, ophthalmic, and topical formulations. Oversee RM (Raw Material) and PM (Packaging Material) characterization and associated documentation in line with regulatory requirements. Plan and manage method validation and qualification projects, ensuring strict compliance with international regulatory guidelines. Serve as SME for analytical lifecycle management—covering method development, validation, transfer, and troubleshooting. Lead interactions with internal regulatory teams and external authorities to address analytical queries pre- and post-submission. Review and support DMF documentation for outsourced APIs, including evaluation reports and follow-up actions. Define product specifications and analytical methods, providing scientific justifications aligned with global regulatory expectations. Ensure audit readiness at all times; handle internal and external audit responses and implement corrective/preventive actions. Provide cross-functional support to Regulatory Affairs, Quality Control (QC), and Manufacturing units. Lead investigations for OOS/OOT results, manage change controls, deviations, and incidents within the analytical function. Drive training, compliance, and capability-building initiatives within the team, including periodic internal audits. Ensure GLP compliance and effective utilization of laboratory infrastructure and analytical instrumentation. Collaborate with formulation leads to align on project timelines and deliverables, ensuring timely submission readiness. Manage departmental budgeting, including material requirement planning and Capex proposals for laboratory upgrades. Continuously evaluate and implement process improvements to enhance efficiency, data integrity, and quality outcomes. Qualifications & Skills M. Pharm / M.Sc. / Ph.D. in Analytical Chemistry or related scientific discipline. Extensive hands-on experience with analytical instrumentation such as HPLC, GC, LC-MS, GC-MS, ICP-MS, etc. In-depth knowledge of international regulatory guidelines (e.g., USFDA, EMA, WHO). Strong understanding of QMS principles, method validation protocols, and GLP practices. Demonstrated leadership skills with experience managing medium to large scientific teams. Excellent communication, stakeholder management, and project execution capabilities. Strong analytical thinking, attention to detail, and ability to make data-driven decisions. Additional Requirements Willingness to work in shifts, if needed, as per business requirements. Flexibility to travel to external manufacturing or R&D sites as required. Relevant candidate can share their CV at pooja.j@domniclewis.com
