Steve has more than 24 years of experience managing process equipment and design for the biopharmaceutical, OSD and cell & gene therapy industries. He has familiarity with operational and regulatory requirements at all stages of process and product development. He has utilized PIC/S Annexes extensively in the past, to ensure adequate contamination control strategies, compliant aseptic equipment and operations for product, and appropriate air classifications within suite design. Steve is a subject matter expert for downstream process and equipment design, including depth filtration, chromatography, UFDF and supporting vessels and clean utilities. He also specializes in upstream process and equipment design, single-use technology, CIP/SIP, aseptic processing, cleanroom design, HVAC and functional integration of automation into processes.
- 20+ years of experience
- Bachelor of Science in Chemical Engineering from Clarkson University