M.Sc.(Analytical) qualified offering nearly 12 years of multifaceted experience in Pharma (Biotech(conjugate vaccines),API and Formulation)Comprehensive exposure in working in USFDA, MHRA, WHO, TGA, ISO certified system and providing leadership for management of activities pertaining to analytical development encompassing method development, preparation of SOP & routine stability analysisExperience in designing methods for new developed formulations and regulatory requirements documentation that will enable organization to consistently meet and enhance qualityComprehensive knowledge of method development using chromatographic, spectroscopic , chemical and biochemical techniquesExposure in designing methods for Macro-molecules such as Polysaccharides, Proteins , Vaccines etc.Proficient in operating and maintaining complex lab equipment.Hands-on experience in troubleshooting on analytical instrumentsmentoring new team membersWorking on polysaccharide conjugate vaccine projectsProviding support on method development, validation and technology transfer activitiesCommunicate with management and other departments concerning progress and results of projects.Initiating stability studies as per regulatory requirementsPreparation of calibration plan, AMC schedule, Validation Master Plan

Rendered Analytical Technical Support to development, optimization of instrumental methods analysis for Formulations (Tablets, Syrups, capsules)Conducted analytical support to routine analysis and technology transfer

Provided analytical support to various analytical works in LabPrepared Method Validation ProtocolsConducted instrumental methods of analysisProvided technical support for procurement of various instruments in analytical laboratory and coordinated with Instrument Engineer for troubleshootingPerformed calibration and documentation of UPLC, HPLC, GC, UV Spectrophotometer, KF Autotitrator, GC, Analytical Weighing Balance in Analytical Laboratory

Raw material, in-process , and finished product analysisManagement of Laboratory standards, glassware’s, reagents, volumetric solutions etc.Preparation of COA’s for finished products