Key Credentials

• Experience in Complex Generics API

• Six Sigma Black Belt certification from ASQ

• PMP certification from PMI • Post-Doc from UT Southwestern Medical Center (Prof. Falck)

• Ph.D from NCL, Pune (Dr. Ganesh Pandey)

Key Achievements

• NDA filing & Co-inventor of the drug Osimertinib (Tagrisso); DS development from MTD to launch including multiple IND filings

• 12 DMFs filed

• Co-inventor of 10 patents

• Authored/co-authored 10 publications in reputed journals

Key Skills

• QbD development for API

• R&D Operational Excellence

• NCE development (Developed Osimertinib at AZ)

• Complex Generics API Development

• Purge Factor Assessment for GTIs

• Nitrosamine Risk Assessment