Sean Searfoss
Senior Director, Quality & Site Head
Sean Searfoss is Senior Director, Quality with responsibility for Quality Assurance, Quality Compliance/Systems, Quality Control and Validation.
Sean brings over 20 years of experience in quality and manufacturing functions in FDA-regulated industries, including medical devices, small molecule pharmaceuticals, and biologics, including gene therapies. He has extensive experience in Pre-Approval Inspections, quality remediation efforts and building robust, phase-appropriate quality systems.
Sean’s most recent role was Senior Director of Quality Assurance at MacroGenics Inc. where he was head of Quality Systems and Operations for the site. A highlight of Sean’s 7+ years of CDMO leadership experience was the implementation of Quality system elements to support initiatives for pre-approval inspection(s), resulting in approval for the first commercial gene therapy at Catalent. Sean held previous quality positions at MacroGenics Inc., Paragon BioServices/Catalent and Pharmaceutics International Inc.
Sean earned a B.S. in Biology from Lock Haven University (Pennsylvania) and his M.B.A from University of Delaware.