

Seasoned Scientist with 9+ Years of Cross-disciplinary research experience covering Regulatory Audits and Compliances (WHO, US-FDA, EU-GMP, S-FDA, TGA, ANVISA, NPRA, CDSCO & GLP) with wide experience for Technology Transfer to International Clients (Germany, Russia, Egypt, Malaysia, Saudi-Arabia, Iran, Cuba & China) and Quality Management System on vaccines/Pharmaceuticals/Biologics Vaccine industry. Conceptualized and designed the establishment of affordable, scalable and robust processes, ensuring the development of safe and Immunogenic high quality vaccines covering both under-utilized as well as new vaccines of public health importance, including COVID-19, Pneumococcal (PCV), Meningococcal (MCV), H1N1, H5N1, Haemophilus-Influenzae B, Tetanus-Toxoid & Hepatitis-B vaccines. Experienced in promoting vaccine regulation and pharmacovigilance, quality assurance and quality monitoring systems.Collaborated for development and use of guidelines on vaccine regulation, quality control/quality assurance of vaccines, Good Manufacturing Practices and laboratory quality control of vaccines e.g. Licensing and Marketing Authorization (MA), Emergency Use Authorization (EUA), Good Regulatory Practices (GRPs), Quality Management Systems and Quality Risks Management.
Institute of Engineering and Technology | Jul 2017 - Oct 2019
Integral University, Lucknow, Uttar Pradesh | 2011 - 2015
Research Scientist | February 2023 - Till Date
Senior Executive Officer (R&D-QC) | July 2021 - Feb 2023
Technical Officer | 2019 - 2021
Assistant Manager (QC) | 2015 - 2017
Successfully Transferred Technology for conjugate vaccines such as Pneumococcal, Meningococcal, H1N1,H5N1, Haemophilus-Influenzae B, Tetanus-Toxoid & Hepatitis-B.
Read MoreProviding end to end solutions to the challenges faced by Pharmaceutical, Biotech and vaccine industry in terms of Facility Design and Project Implementation, Manufacturing, Product Development, Scale-up & optimization, Business Development Strategies, Quality Management, Manpower Development and Intellectual Property Rights.
Read MoreGMP and GLP audits and compliances for US-FDA, EU-GMP, S-FDA, TEVA, TGA, NPRA, ANVISA, CDSCO and WHO as well as other domestic audits and inspections subjected to other third-party and loan licensed manufacturers.
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