Formulation Development, Method Development and Characterization Expert

Uttam Kumar Tripathi

Indore, MP, India
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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