MICHELE LEVENSON

Ms. Levenson brings 18+ years of   experience in the biopharmaceutical, pharmaceutical, and medical device/diagnostic industries with an emphasis on process, equipment, utility, facility, computer, and automation validation as well as project and people management. Ms. Levenson’s areas of expertise include equipment/facility/utility/automation commissioning & qualification, quality management systems, statistical analyses, process design and process validation. Her expertise spans solid dose manufacturing delivery systems to aseptic biotech processes and drug delivery systems. Throughout her career she has been involved with process and technology transfers, process optimization and redesign projects, and cell culture fermentation operations.  Ms. Levenson has been extensively involved in leading commissioning and qualification mission critical projects for gene therapy, pharmaceutical, and biotechnology companies. Additionally, she has been fully engaged in remediation activities of pharmaceutical and biotechnology companies that are under regulatory action specifically for Process Validation in the US and was involved in the development of policies and procedures for process validation programs deployed around the world. Ms. Levenson is a Lean Six Sigma Green Belt and Certified Project Management Professional (PMP) with a B.S. degree in General Life Sciences and a Minor in Spanish from Penn State University in State College, PA.