Molecular Biologist
CurrentLeading multiple cross functional & locations teams- R&D team, Regulatory Affairs & business developmentR&D grant proposal writing ,submitting , presenting & defending to funding agencies in India like Deppt of Biotechnology, Dept of S&T,Technology Development Board-GOI and International Agencies like FDA-Biz opportunity-US ,JRC-EU etc and MNCs and consulting & research partnership for collaborative projects with national R&D institutes, Business and Marketing plans writing and validating.R&D team -biomarker discovery (identification and validation of bio-marker for drugs discovery using comprehensive genomic reference databases), Product development on Rapid (qPCR)Molecular Diagnostics kits (Infectious diseases) , Molecular food diagnostic( Rapid qPCR-DNA test for pathogens, GMO), Genomics and Next Generation Sequencing.Work with BioServe US on cross-border R & D projects involving bio-marker discovery with global potential such as inflammatory disorders, endocrine disorders, cardiovascular disease, hypertension, obesity etcTranslating R&D into products and services after validation and testing & thereafter commercializing these after obtaining regulatory approvalsRegulatory Team on liasoning and quality management system and a detailed orientation on ISO 17025:2005, 15189:2007, ISO 13485:2003 , FDA501K,CE marking certification & 9001:2008. Initiatives on liasoning with regulatory bodies and well versed with FDA regulations, ICH guidelines, EU regulations and CSDO in the area of molecular diagnostic, FDA-US, EU, AFNOR,ISO, Centre for Disease Control, Clinical Laboratory Standard Institute Institute USand nodal agencies like Export Inspection Council, BIS,APEDA, NIN , NABL and ICMR etcBusiness Team: Strategic planing & execution, strategic business and technology alliances in genomic biomarker , next generation diagnostic consumables ,MDx ,Next Generation Sequencing.Financial and Market Modelling.