Expertise on following topics
# Products Handling: Injectable, complex injectable (microspheres, Liposomes & Nanotubes), both liquid and lyophilized, Parenteral Nutrition, IR OSD and ER OSD, Ointments & Biosimilars
# Method development, Structural and Polymorphic Characterization for RE and Q1/Q2 sameness & (Q3) similarities
# Specification setting and various protocols & reports, STP & SOP preparation
# Products Handled: OSD (ER & IR) and Injectables, Complex injectables, Ointment
# QbD based Product Development, Statistical data analysis and interpretation
# Good understanding of ICH, FDA and other regulatory guidelines & CMC requirements
# Project planning & management and Data integrity practices implementation # Effectively communicate and collaborate with technical team, Business Development, and Management
# Hiring & performance management
