Hari Narayan Kushwaha

WORK HISTORY

EDUCATION

ABOUT HARI NARAYAN KUSHWAHA

A pioneered manager and analytical scientist with research experience and thorough knowledge of analytical for drug substance and drug product. Experience of Literature search, strategic planning, execution and monitoring of projects for analytical research and throughout the lifecycle of drug substance ad drug product (early stage of development to late stage of development). Manpower and resources planning as well as day to day planning and supervising LCMS team activities to support multiple teams in terms of method development, reaction monitoring and routine analysis, method validation, method transfer to plant site for validation, stability studies, trouble shootings at R&D and plant site, OOS & OOT, customer queries and deficiencies and regulatory filing. Literature search, LC-MS, LC-MS/MS, HRMS and GCMS studies for structure elucidation, impurity profiling and identification of unknown impurities in drug substance and drug products observed during reaction monitoring and process optimisation, lab validation, scale-up in kilo-lab and manufacturing at plant site. Expertise with Sophisticated and hyphenated techniques for reaction monitoring, impurity profiling, chromatographic purity, related substance, assay for raw materials, intermediates and finished products of drug substance and drug products. Literature search, method development and validation for estimation/quantification of mutagenic, non-mutagenic, common nitrosamines and nitrosamine drug substance related impurities (NDSRIs) as well as extractables and leachables in different drug substances and drug products. Comprehensive understanding of regulatory guidelines for preparation and review of standard operating procedures, standard test procedures, protocols, specifications, certificate of analysis and relevant documents related to internal and regulatory approval audits. Performance and record maintenance of Annual Maintenance Contract, Comprehensive Maintenance Contract, daily, quarterly and half-yearly calibration records of instruments. Timely KRA submission and annual appraisal of myself and my team members. Co-ordination with different Stakeholders like chemical research, quality control, production, regulatory, business development etc for project progress updates as well as queries and deficiencies of customer and agencies. Supervision & motivation of team members and ensured KRA as well as annual appraisal and implemented systems for continuous improvement of communication and analytical tools and methodologies.