A dynamic professional with more than 19 years of rich experience in R&D, production, technical operation & troubleshooting, product management, Manpower management, business planning, Infrastructure development QA, and regulatory affairs.Presently working with RFCL Limited as General Manager- R&D/QA/Production and technical operation.Expertise in manufacturing of Immunodiagnostic products, which includes ELISA, Chemiluminesence, Rapid tests based on Immunochromatography, Flow through, Lateral flow Dip sticks, agglutination based tests, Hematology and Biochemical reagents.Planning and control of operational activities in compliance with cGMP norms and their implementation.Effective team management skills, Planning, execution and implementation of various production activities including machinery set up and their problems resolving.Exposure to R&D,QA/QC, Manufacturing, application support, marketing, technology transfer, regulatory affairs, Products licensing, ISO,CE certification activities and collaboration with national/ international research institutions, universities & industries. Knowledge of international laboratory standards. Setting up the facility, highly dedicated and target achiever.Well versed with rDNA technology and recombinant protein expression, purification and characterization methods.Expertise in planning and organizing day-to-day research activities and resolving procedural/ logistical problems as appropriate to the timely completion of research objectives. An effective communicator with excellent relationship building & interpersonal skills.Writing up the training manuals, protocols, procedure, SOPs, BMR, and other documents as per the regulatory norms.Specialties: Biotechnologist having more than nineteen years of experience in R&D in the field of Immunodiagnostic, Microbiology, Molecular biology, Hematology, clinical biochemistry, New drug discovery and Protein chemistry. Familiar with cGMP, FDA, WHO regulations, QA/QC activities and regulatory compliances.