Mihaela Simianu

A life-long learner with a passion for science applied towards medical innovation and manufacturing processes, Mihalea Simianu, PhD. has spent the past 25 years at the forefront of pharmaceutical research, standards, manufacturing, quality, and commercialization for some of the world’s leading pharmaceutical brands including, Eli Lilly, Amgen, and Merck.

Dr. Simianu is recognized by her peers as a transformational leader in the biopharmaceutical industry. Her focus has been on delivering business operation outcomes; the modernization of development, quality and manufacturing systems, as well as the adoption of new technical capabilities. Mihaela’s career has taken her around the world and her technical knowledge has helped with the approval of seven new commercial products, and the introduction of commercial processes at nine manufacturing sites in the United States and Europe. She has overseen the manufacturing of 20 commercial products both internally and through contract manufacturing sites.

Dr. Simianu is considered to be an authority and sought-after speaker for pharmaceutical commercialization, quality, and innovation. She regularly speaks on data and knowledge-based R&D: product and process QbD development, validation, transfer, and life cycle management for a large range of therapeutic modalities. She sponsors and engages industry peers and partners to advance global parenteral manufacturing, parenteral products closure systems design. She engages in adoption and advancement of new technologies, adding laboratory and pilot capability as platforms for investment into rapid experimentation and change from status quo.