Description
A strategic new product development leader with over twenty years of accomplishments in a cross functional role spanning multiple therapeutic areas in small and multinational companies with continued success in innovator specialty and drug-device product formulation CMC strategic portfolio/program management/planning IP mission critical decision making phase appropriate product development NIH grant writing regulatory clinical supply strategic compliance approval and launch. Possess working knowledge in drug delivery biochemistry non-clinical and clinical operations. He holds B.S M.S. in Pharmaceutical Sciences and Ph.D. in Pharmaceutical Chemistry. Also he is a self- motivated excellent communicator and objective leader to drive projects to completion and certified in Biotechnology Project Management. Open for relocation. Track record is attached. Due diligence Feasibility analysis Contingencies Process Analytical Clinical supply Clinical (Bio-equivalence PK Effectiveness) Non-clinical and Toxicological qualification Products Designed Ophthalmic emulsion (dry eye) Filled auto-injectors (Epi-pen) Iontophoretic Trans-dermal Ungual drug-device combination products Chronopharmacological temporal drug-device products DPI respiratory drug delivery Contributed several patents (9) publications/abstracts (17)