AGM- Analytical Method Validation

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.

pooja.j@domniclewis.com