Ms. Unger has over 25 years of experience in biologics, cell and gene therapy, antibodies and biosimilars including a venture capital start up, big pharma, big biotech and many years of consulting in the area of GMP Quality.
Barbara’s experience includes hands on experience in CMC Regulatory Affairs for new products and GMP Quality support for clinical trial materials and commercial production, including preparation for PAIs, routine GMP inspections and warning letter remediation. She has most recently focused on GMP due diligence evaluations and GMP auditing including evaluations of data integrity and data governance.
Barbara chaired the GMP Intelligence subgroup of the Midwest Discussion Group for four years. She was also the initial chair of the Rx-360 Monitoring and Reporting group in 2009 that identified and summarized new GMP regulations and guidance relevant for the pharmaceutical industry. She currently co-chairs the Rx-360 Working Group on Data Integrity.
Prior to her association with Pharmefex, Barbara formed Unger Consulting Inc. after retiring from Amgen Inc in 2014. At Amgen Inc. she was a Director of Quality and led the corporate GMP audit program for API, drug substance, Quality Systems and Computers in addition to developing and implementing the corporate GMP Intelligence Program. Prior to Amgen, Barbara was a consultant with Don Hill and Associates serving the biopharmaceutical industry. She also worked for Eli Lilly and Company in CMC Regulatory Affairs after starting her career at Hybritech Inc in San Diego. Barbara holds a B.S. in Chemistry from the University of Illinois in Urbana IL.