Koshy George

Koshy George is Associate Director of the Manufacturing, Science and Technology at Pii. He began working for Pii in 2003, setting up the Validation/Qualifications and Technology Transfer department as a group leader within the Formulation Development and Operations Departments. Mr. George has successfully performed numerous product tech transfers (site change, pilot-scale development, commercial scale), validated, and launched multiple New Drug Applications (orphan drugs, hormones, potent, DEA-schedule drugs, veterinary chewable tablets, tablet in tablet and softgels) and Generic Abbreviated New Drug Applications (tablet, hardgel capsule, softgel capsules, nanosuspension, solution, lotions, creams, and ointments) throughout his tenure at Pii.

Mr. George has more than 25 years of experience in Oral Dosage Formulation Development, Quality Compliance/Assurance, Manufacturing Science & Technology, Product Life Cycle Management, Process and cleaning validation, CSV, Calibrations, Tech Transfer, and Packaging with DSCSA emphasis. He has dual Graduate degrees: a Master of Science in Pharmaceutical Sciences and a Master of Science in Biotechnology from the University of Maryland, Baltimore County. He holds certifications from the National Institute of Health (NIH) in Clinical Pharmacology and in Clinical Research and is affiliated with the International Society for Pharmaceutical Engineering and American Association of Pharmaceutical Scientists, through memberships and mentorship programs.