Hemant Kumar Bakshi Email and Phone Number

I am an experienced R&D professional with about 2 decades of insightful experience in Analytical - Research & Development. I am ensuring the on-track running of key activities related to product development in the pharmaceutical industry coupled with expertise in managing Chromatographic based instrumentation, Physio-chemical analysis, and Data analysis.My focus remains on driving strategy associated to pharmaceutical analysis of Drug Substances and Drug Products, primarily with generic pharmaceutical organizations. I am continuously working and sharing my technical inputs by utilizing broad knowledge across Analytical Method Development, Validation, Transfer, Pre-formulation Studies, Impurity Profiling, and E&L Studies.I am competent in leading R&D’s analytical team with a focus to drive analytical strategy and provide training to improve productivity of the organization.My significant highlights include:► Core Belief is attuned to team work and leadership culture with an objective to provide excellent services and support from analytical department.► Specialties - Analytical method development, validation, transfer and stability studies of different kind of formulations dosage forms.► Set up the Analytical Laboratory as per cGLP/cGMP norms, as well as establish the system in tune with quality and regulatory requirements.► Involved in strategies for Technical transfer of Analytical Methods from R&D to plant.► Qualification of analytical instruments as per CSV guideline.► Facing different regulatory audit (USFDA, MHRA, CDSCO and different client audits) and response to the observations and CAPA preparations► Managerial skills - Problem solving through application of knowledge, Understanding client expectations and leading all client communications, setting up the Capex & Opex for analytical lab, training, adhere safety norms at work place, people management.In addition, I am working in cGLP/cGMP environment, supervise the microbiology laboratory for non-sterile products (BET, MLT, PET/AET), trained in handling of LIMS, SAP, QMS (Change control, Deviation, Incidents etc.)