Edward De Simone
About Edward De Simone
Edward De Simone serves as the Vice President of Product Development at ANI Pharmaceuticals, Inc. since 2020, bringing extensive experience from his previous roles at Eli Lilly and Company, where he held various positions over a span of more than a decade.
Work at ANI Pharmaceuticals
Edward De Simone has served as Vice President of Product Development at ANI Pharmaceuticals, Inc. since 2020. In this role, he oversees the coordination of functions within Product Development to ensure optimal development strategies and technical solutions. He collaborates with Sales, Marketing, Operations, and Regulatory Affairs to develop product pipeline strategies and prepare FDA discussion documents. Additionally, he plays a key role in preparing Chemistry, Manufacturing, and Controls (CMC) sections for regulatory filings. His previous position at ANI Pharmaceuticals was as Director of Analytical Services from 2018 to 2020.
Education and Expertise
Edward De Simone holds a Bachelor of Science in Chemistry from Creighton University, where he studied from 1996 to 1999. He further advanced his education by obtaining a Master of Science in Biochemistry from Purdue University, completing his studies from 2004 to 2005. His educational background provides a strong foundation for his extensive experience in analytical chemistry and product development within the pharmaceutical industry.
Background
Edward De Simone has a significant history with Eli Lilly and Company, where he worked in various roles from 2003 to 2017. His positions included Analytical Chemist, Senior Analytical Chemist, Associate Analytical Chemist Consultant, Chemist Consultant, Quality Control Manager, and Operations Manager. This diverse experience equipped him with a comprehensive understanding of the pharmaceutical development process and quality control measures.
Achievements
Throughout his career, Edward De Simone has contributed to the development of systems for project management and tracking within the Product Development team at ANI Pharmaceuticals. He leads the selection and management of Contract Research Organizations (CROs) and vendors related to Active Pharmaceutical Ingredient (API) and formulation development. His collaborative efforts across various departments have been instrumental in advancing product pipeline strategies.