Nandkishore Yadav

WORK HISTORY

EDUCATION

ABOUT NANDKISHORE YADAV

Passionate leader with 20 years of industrial experience, specializing in formulation development for regulated markets, including compliance with global regulatory agencies such as USFDA, EMA, and other international authorities. Successfully led numerous formulation projects from concept to commercialization, ensuring product efficacy, stability, and regulatory alignment.Specialties: • Leading three teams of dedicated and enthusiastic formulation scientists to ensure timely development and delivery of R&D projects.• Preparing and presenting project status reports for quarterly R&D reviews to senior leadership.• Responsible for Regulatory audits and timely response to regulatory queries from USFDA and EU regulatory agencies.• Specialized in solid powder layering on pellets with proven scalability to commercial manufacturing levels.• Successfully scaled up solid dispersion techniques using Hot Melt Extrusion (HME) and Spray Drying technologies.• Driving development and on-time delivery of First-to-File (FTF) generic products.• Actively involved in budget planning, technology adoption, and manpower management for R&D operations.• Expertise in QbD-based development of generic solid oral dosage forms for US and EU markets.• Skilled in formulation and process optimization using Design Expert and Minitab software tools.• Developing robust control strategies for formulation and process components.• Conducting Failure Mode and Effects Analysis (FMEA) for risk mitigation in formulation and process design.• Proficient in data analysis, drawing actionable conclusions, and establishing development plans to meet project timelines.• Knowledgeable in Process Analytical Technology (PAT) tools and root cause analysis using Ishikawa/Fishbone diagrams.• Overseeing technology transfer and execution of validation batches at manufacturing sites.