Scientist, Technocrat, avid researcher, subject matter expert with over Three decades of experience with important government organisations and prominent private sector entities. Expertise in dealing with innovations, startups, accreditation and regulatory testing for Biotechnology derived Therapeutic / rDNA products) and In-Vitro Diagnostic products. Expert in emerging technologies in areas of AI, IoMT, LIMS, QMS, and Regulatory Intelligence. Served as program coordinator for Support Cell WHO-PQ & WHO-CC at National Institute of Biologicals (NIB), for In-vitro Diagnostics. Served as Expert panel member of Biotechnology Industry Research Assistance Council, Department of Biotechnology (BIRAC - FIRST-HUB) committee, a Facilitation Cell for the Start-ups/ innovators and for those who want to take up R&D in pharma and devices.Contributed significantly in establishing various QC laboratories at NIB, preparation of SOPs, QC test method development and validations engaging cutting edge technologies, leading to generation of pharmacopoeia monographs, dossier review, post approval changes as per prevailing regulatory guidance's.Developed & implemented basic training programs for PG students of Biopharma in alignment with current industrial practices.Research on upcoming segments relating to medical devices by supporting establishments associated with R & D, Innovations, Rapid Prototyping, 3D printing, manufacturing sector, strategy creators, Information vaults, and go to market. Ability to multitask across platforms (Regulatory science, thorough knowledge base of various QMS, WHO, ICH, ISO & CLSI data standards/guidances, Informatics & Accreditation services). Well experienced in QC/QA of Biologics (Biotherapeutics/rDNA products - TmAbs, Therapeutic Enzymes & Hormones, Immunodiagnostics - Infectious disease marker testing) in a well regulated, fast paced environment for Biologics & In-vitro Diagnostics.Core strength areas are QC & QA of In-vitro Diagnostics, Biologics, Design & Development of Reference standards, application of relevant Data standards, Biobanking/Biorepository, cGMP, GLP, LIMS-ALCOA++, Quality Management Systems (QMS) ISO - 17025, 13485, 15189, 14971, 17043, 17034 & 33, OHSAS & QHSE.Served as project lead for Artificial Intelligence based in-house Laboratory Information Management System (LIMS) development at NIB.Research in Bioinformatics engaging Artificial Intelligence, Machine and Deep Learning methodologies.