1. Have been involved in Analytical Method Development, Analytical Method Validation, Analytical Method Transfer for global market including USA, Europe, CANADA.2. Have been involved in analytical method development and Characterization of Injectable (Simple include - Injection, Lyophilized formulation, and Complex include - Liposomal, Emulsion, Suspension. Prefilled Syringes, Pen devices and Peptide formulation-Protein Aggregation, Amino acid analysis, peptide mapping), Semi Solid formulations (Soft Chews, Soft Gelatin).3. Have been involved in analytical method development of RS, Assay, Cleaning Method, Admixture Study, Diluent Compatibility Study, Excipient Content such as Antioxidants, Preservatives, Lipids and Impurities of Excipients (Lipid) such as LysoPhosphatidylcholine, Free Fatty Acid etc. 4. Have been involved in review of M3 Module Dossier for Drug Substance and Drug Product, DMF, VMF and COAs for Vendor Qualification, LIR, OOS, OOT Investigation, Nitrosamines Risk Assessment, Elemental Analysis and Risk Assessment, E&L Analysis, Delamination Study, Unknown Impurities Identification and Characterization and finding it's degradation pathway.5. System knowledge : HPLC, UPLC, UHPLC, IC, LC-MS (Empower, Chromeleon, Lab solution and Open Lab software), Malvern Zeta Sizer (Particle Size & Zeta Potential), UV Spectrophotometer, IR Spectrophotometer, Dissolution Apparatus (USP-I,II,IV), KF Coulometer and KF titrator, Universal Testing Machine for PFS tests such as Glide force, Break loose force, Bottle Rotating Apparatus (Liposome-IVR) etc.