Dr. Simianu is a transformational and influential leader in Bio-Pharmaceutical industry, poised to advance realization and supply of technology and therapeutic products in service of personalized medicine and public health outcomes She has delivered business, technical and operation outcomes for large biopharmaceutical. Led to successful approval of more than twenty (20) new therapeutic agents. Operated cross-functionally and applied boundaryless leadership principles in complex matrix organizations. Directed teams on the introduction of commercial processes at more than (thirty) manufacturing sites in US, Europe, and Asia. Managed technical groups responsible for implementation of post-approval changes for more than forty (40) commercial products manufactured at Merck &Co, Amgen, Eli Lilly and their respective Contract Manufacturing Organizations. Currently Dr. Simianu is Scientific Advisor at SmartSkin Technologies and President of Concordia MCS, LLC, applying strategic and tactical expertise in sterile product end-to-end life cycle management to guide executives, business, operations, technical and quality leaders achieving targeted outcomes for modern or legacy therapeutic agents (biologics, vaccines, and pharma products).