Keith 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.  Keith 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.  He has expertise in the implementation of online TOC instruments 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 Cleaning Process Development Lab in 2011, 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.  Keith is currently an elected member of both the Board of Directors for the Rocky Mountain Chapter of ISPE and the Mountain States Chapter of the Parenteral Drug Association.

Keith is currently a member of the International Society for Pharmaceutical Engineering (ISPE), the American Institute of Chemical Engineers (AIChE), and the Parenteral Drug Association (PDA).