Barb has been working in the pharmaceutical industry for over twenty years. She has worked extensively across multiple types of therapeutic formulations for approvals in the US, Canada, Europe, Australia, Britain, Brazil and Japan. Her experience spans quality and operations, including strategic leadership roles in quality control, quality assurance, project management, and clinical trial manufacturing. In her operations, laboratory, and quality roles, Barb has worked directly with drugs from innovation, through clinical trials, through registration, and to commercialization, and has directly supported the CMC process; this includes pre-IND documentation, FDA interactions, and creation and editing of the submission documents for CTD e-filing. She has worked with innovator drugs, generics, and commercial products with orphan indications ranging from diluents to small molecules, peptides, proteins, encapsulated DNA and adjuvated vaccines.
She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and in Pharmacological & Physiological Science. She received her Project Management Professional certification in 2007, her Six Sigma Green Belt in 2008, and her Certified Manager of Quality/Operational Excellence and Certified Quality Auditor from the American Society for Quality in 2015.