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Manish Kumar Sharma

Manish Kumar Sharma
Research Scientist- Analytical Research and Development, Amneal Pharmaceuticals
Brookhaven, New York, USA


12 years of educational and research experience in pharmaceutical analytical research and development and co-authored 7 published, research publications and 3 submitted peer reviewed high impact research publications.
Research in the field of corrosion and passivation of advanced metallic materials in various media
Vast experience of generic pharmaceutical industry (ANDA-Abbreviated New Drug Application) to develop affordable and bioequivalent generic drugs.
Experience on HPLC, UPLC, GC, GPC, GC-MS, Dissolution Apparatus (USP I, II, III, IV, VII), XRD, TPW, Rheometer and Malvern Mastersizeres.
Proficiency in Analytical Method Development and Validation of pharmaceutical and bio-pharmaceutical products (ANDA and NCE), parenteral (Injection, powder for Injection, suspension for injection), solid oral-Rx and OTC (tablet, capsule, soft gel capsule, birth control pill), ophthalmic (solution, suspension), topical (gels) and liquid orals (syrup, powder for suspension) formulation projects.
Experienced in Bio-relevant dissolution testing method development and “in vitro-in vivo correlation” (IVIVC) for immediate and controlled release products.
Strong analytical, problem solving and interpersonal skills with solid work ethics.

Research Interest

Pharmaceutical analytical research, corrosion and passivation of advanced metallic materials, Generic pharmaceutical Analytical Method, Development and Validation of pharmaceutical and bio-pharmaceutical products.