Keith Bader has nineteen years of experience with specific expertise in project engineering, aseptic process engineering, cleaning process development, and validation, cleaning reviews and gap assessments as well as Pre-Approval Inspection (PAI) Readiness.
Through the years, he has provided high level consultation to Hyde’s engineering 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 scale up 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.