An analytical scientist with passion for analytical research. 24+ years of rich experience in pharmaceutical industry with proven leadership skills. Currently leading multiple teams of analytical scientists and working towards filing of ANDAs. Expert in the core area of analytical research, method development & method validation for drug product and drug substance. Adept at: * Trouble shooting and resolving complex problems from analytical front. * Analytical Method validation of drug product & Drug substance, excipients, drug intermediates key starting materials & in process tests. * Addressing regulatory queries* Supporting manufacturing sites on analytical/Quality investigation. * Applying QbD principles for analytical method development. * Preparation & review of analytical technical documents for ANDA and DMF submission. * Providing effective CAPA for incidents. * Stability testing of drug substance & drug product. * Prediction of drug degradation pathway & Drug excipient interactions. * Enriching degradation products and isolation by prep-HPLC and by manual procedure. * Handling of onco drugs. * Maintaining GLP and Safety in analytical development laboratory. *Trace level impurities quantification (like genotoxic impurities, elemental impurities). * Nitrosamine risk assessment in drug product, drug substance, method idevelopment by LCMS and GCMS. Instruments proficiency: HPLC, UHPLC, GC, LC-MS, prep-HPLC, Auto titrators, Malvern Particle size analyzer, DSC, TGA, IR, UV, Dissolution apparatus, Polarography, TLC scanner , XRD, ICPMS, GCMS, M4 Morphologi.Professional efficiency : Capable of aligning multiple stake holders as per the requirement of projects. Creating conducive working atmosphere to the team. Quick & Firm decision maker. Recruitment of talents for the team.Ready to take senior Leadership role in analytical / quality/regulatory functions.