Keith E. Bader

Keith holds a Bachelor of Science degree in Chemical Engineering from the University of Colorado at Boulder. He began his career conducting government contract research in catalysts and advanced materials through SBIR grants. Following that, he joined Hyde Engineering + Consulting, Inc. in 1999 and worked in a variety of areas from control system development to cleaning validation. Through the years, he has provided high level consultation to Hyde’s Engineering's clients in topic areas ranging from strategic quality and validation documentation architecture to detail oriented support such as design of experiments and supporting study design. Keith has focused in recent years on the implementation of online instrumentation and process analytical technologies for clean- in-place systems, as well as the translation of bench scale cleaning process development data to full scale manufacturing systems. Leveraging this expertise, Keith founded Hyde’s CORE Lab in 2012, a facility devoted to the development, exploration, and scaleup of cleaning processes for the pharmaceutical and biopharmaceutical industries. Keith has also published multiple journal and periodical articles as well as chapters in PAT Applied in Biopharmaceutical Process Development And Manufacturing: An Enabling Tool for Quality-by-Design by Duncan Lowe, and in Cleaning and Cleaning Validation, Volume 2, edited by Dr. Paul Pluta.