Edward Desimone

About Edward Desimone

Experienced leader with a demonstrated history of working in the biotechnology industry…

Experience

1. Vice President of Product Development

   ANI Pharmaceuticals, Inc.

   Jul 2020 — Present

   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

  1996 — 1999

• Purdue University

  Master of Science - MS, Biochemistry

  2004 — 2005

Skills

• Biotechnology
• Sop
• Validation
• Chromatography
• Purification
• Quality Assurance
• Six Sigma
• Fda
• V&V
• Change Control
• Gmp
• Gxp
• Pharmaceutical Industry
• Protein Chemistry
• Capa
• Technology Transfer
• Standard Operating Procedure (Sop)
• Root Cause Analysis
• Hplc