R&D Methodology &Validation Section Head

Lead and oversee the development, validation, and transfer of analytical methods.Ensure all methods are compliant with regulatory requirements and align with EDA, ICH, FDA, and EMA guidelines.Develop and implement strategies for method optimization, troubleshooting, and validation processes.Develop and issue analytical methods, establish method specifications and define acceptance criteria within the necessary thresholds, ensuring compliance with regulatory standards set by ICH, WHO, FDA and EMA.Manage a team of analytical chemists, providing mentorship, training, and performance feedback.Coordinate with cross-functional teams (Quality, R&D, Production) to support product development and regulatory submissions.Monitor and evaluate emerging trends in analytical science and adapt methods accordingly.Lead investigations related to method-related OOS/OOT results, deviations, and CAPA implementation.

Bachelor’s degree in Pharmacy or Science, Master’s degree in Analytical Chemistry, Pharmaceutical Sciences is preferred.Minimum 15 years of relevant experience & at least including 3 years in SH role.Strong expertise in chromatography (HPLC, UPLC, GC), mass spectrometry, and other modern analytical techniques.In-depth knowledge of global regulatory guidelines (WHO, ICH, FDA, EMA) for analytical method validation.Excellent problem-solving skills, with a detail-oriented approach to analytical challenges.Pharmaceutical industry experience is a must .