Edward Desimone
Vice President of Product Development @ANI Pharmaceuticals, Inc.
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WORK HISTORY
Vice President of Product Development @ANI Pharmaceuticals, Inc.
Serve as a member of the executive team that sets the company’s strategic direction for Product Development. Lead all aspects of product pipeline and pharmaceutical development, including API selection, sourcing formulation development and optimization, analytical methods development and validation, methods transfer, CMC, scale-up, packaging, stability studies, management and distribution of clinical supplies, and preparing CMC sections for regulatory filings. Where applicable, provide leadership for activities supporting commercial launch. Support in developing systems for the management and review of projects and provide/develop project tracking reports. In collaboration with the Product Development, Operations, Business Development, Quality and Regulatory Affairs teams. Ensure Product Development strategies, budget and timelines are consistent with development plans and goals. Oversee Product Development coordination of functions to ensure optimal development strategies and technical solutions. Select and manage Product Development CRO’s and vendors as the relate to API and formulation development and coordinate relevant activities. Work closely with Sales/Marketing, Operations and Regulatory Affairs to develop product pipeline strategies, proposals, FDA discussion documents, presentations, and filings.
EDUCATION
Creighton University
Bachelor of Science - BS, Chemistry
Purdue University
Master of Science - MS, Biochemistry
SKILLS
ABOUT EDWARD DESIMONE
Experienced leader with a demonstrated history of working in the biotechnology industry…
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