Mihaela C. Simianu

Dr. Simianu is an experienced executive leader in Bio-Pharmaceutical industry. She has diverse and deep expertise in development, commercialization and international manufacturing of complex bio-pharmaceuticals and delivery systems used in the treatment of multiple forms of cancer and diseases associated with endocrine, cardiovascular, neurological, and immunological disorders.

She successfully built new and flexible technical organizations, implemented improvements to development, quality and manufacturing systems, and has established technical and social capabilities that contributed to the success of multi-billion dollar organizations. She is a transformational leader experienced in modernization of practices applied to drug product design and life cycle management. She has extensive experience integrating suppliers into pharmaceutical systems required to achieve product quality by design.

In her role with Pharmatech Associates she guides companies to apply a tailored “Compliance trough Science “approach to commercialization of complex therapeutic agents, balancing regulatory, compliance, and technical requirements with business needs.

In her tenure, as Executive Director of Parenteral Product and Process Development at Amgen and Research Advisor in Manufacturing Science and Technology at Eli Lilly she was responsible for qualification and validation activities leading to the approval of seven new commercial products. She was part of commercial processes introduction at nine manufacturing sites in US, and Europe. She managed technical groups responsible for implementation of post-approval changes for over 20 commercial products manufactured at Lilly, Amgen and Contract Manufacturing sites. As a recognized international industry expert, she has spoken and published on many occasions on application of science to quality and manufacturing practices.

Dr. Simianu holds a MS/BS in Chemical Engineering and Pharmaceutical Technology from University of Cluj-Napoca, Romania and a Doctorate Degree in Chemistry from Marquette University, Milwaukee, WI. She was certified in Creating Winning Strategies by Jack Welch Management Institute.