Tara Gooen Bizjak has been with the FDA for over 11 years. She started at FDA as an investigator in the New Jersey District, performing domestic and international drug manufacturing inspections. In 2007, she transferred to the Center for Drug Evaluation and Research (CDER), Office of Compliance, Division of Manufacturing and Product Quality, to the Guidance and Policy Development Team. She is a subject matter contact for several CGMP topics including pre-approval inspections, continuous manufacturing, water quality, isolator technology, and scale-up issues. Tara Gooen moved into the pre-approval world in 2009 as a Team Leader for manufacturing assessment and pre-approval compliance of new and generic drug applications. She is currently acting in the role of Branch Chief for the new drug manufacturing assessment branch and continues to perform inspections. She has a B.S. in Chemical Engineering from Cornell University and a Masters in Biomedical Sciences from the University of Medicine and Dentistry of New Jersey.