Herman F. Bozenhardt BSChE, MSSE

President, Bozenhardt Consulting Services LLC

Herman Bozenhardt has 44 years of industry experience in the areas of pharmaceutical manufacturing, aseptic filling, biotech manufacturing, engineering, and compliance. His expertise ranges from renovation of aseptic facilities and systems to achieve best practices and Annex 1 compliance, to process development to enable a clinical trial level product to achieve commercial success. Mr. Bozenhardt has worked in numerous manufacturing facilities and has engineered and designed manufacturing for application in BL-1, BL-2, and BL-3 and achieved compliance with the CDC, ECBC, and within the FDA and the EU jurisdictions. He writes a monthly column in pharmaceutical processing online.com and bioprocessing online.com, has 4 e-books on pharmaceutical processing, engineering, and related business practices, and conducts podcasts on pharmaceutical topics. He has a BS in Chemical Engineering and an MS in System Engineering, both from the Polytechnic Institute of Brooklyn (now NYU).