Nessiem Samuel

Nessiem Samuel has over 20 years of industry experience in Compliance and Validation. He is a recognized expert in Commissioning, Qualification and Validation, enterprise systems, asset management lifecycle management, GLP, Change Control, CSV, PPQ, Process and Cleaning validation. He has a demonstrated record leading and developing major cross-functional teams. He is also a leading expert in Process Performance Qualification. He spearheaded and managed 3 First to Market ANDAs and 9 NDAs, including most recently the First Worldwide Gene Therapy CDMO commercial approval.