Mr. Le brings over 35 years of manufacturing, quality, and overall operations experience with devices and complex drug-device combination products. From 2011 to March 2020, Mr. Le was the Chief Technical Operations Officer for Dance Biopharm – a leader in aqueous respiratory therapy delivery with Drug and Device combination products – he built the Operations, Quality Systems, Manufacturing, Supply Chain, Product Development, Formulation, and IT teams (from very early stages). From 2009 to 2011, Mr. Le was the Chief Operating Officer for Avid Bio Services, Inc., a leading contract manufacturing organization that specializes in clinical trials and commercial distribution of monoclonal antibodies and recombinant proteins. From 2007 to 2009, Mr. Le served as the EVP Manufacturing and Quality for PrimaBiomed, a cell therapy company, and as a consultant for several drug/device companies.

From 2001 to 2007, Mr. Le was Senior Vice President of Operations, Product Development, Quality, and Regulatory Affairs for Nektar Therapeutics, a biopharmaceutical company, where he led the commercial formulation and device manufacturing for Exubera. From 1999 to 2001, he consulted for multiple large pharmaceutical and medical device companies (Abbott, Medtronic, Baxter, Dow Chemical) specializing in Due-diligence, Operation Effectiveness, and PAI readiness. From 1981 to 1999, Mr. Le was employed for a division of Johnson & Johnson, as the Worldwide Vice-President of Regulatory Compliance and Quality Systems. His work at Johnson & Johnson included 10+ years in operations, regulatory affairs, product development, manufacturing, and quality for ophthalmic products such as cataract devices and implants and drug products for ophthalmic surgery procedures.

Mr. Le has a B.S. in mechanical engineering, M.B.A. in Management, and completed numerous executive leadership training programs, including World Class Manufacturing at Duke University, Executive Management at Harvard University, and a QSR trainer at AAMI/FDA.