Brett Budis
About Brett Budis
Brett Budis is the Director of Global Regulatory Sciences CMC Operations and Intercon Support at Bristol Myers Squibb, with extensive experience in biologics quality assurance and regulatory compliance.
Title
Brett Budis serves as the Director, Global Regulatory Sciences CMC Operations and Intercon Support at Bristol Myers Squibb, located in Lawrenceville, New Jersey.
Company
Brett Budis is currently employed by Bristol Myers Squibb. At this company, he holds a senior leadership position overseeing global regulatory sciences CMC operations and intercontinental support.
Career Background
Brett Budis has an extensive career at Bristol Myers Squibb, starting from the role of Group Leader, Operations in 1996. He transitioned through multiple roles including Associate Director and Interim Director, QA/QC. From 2007 to 2010, Budis served as Associate Director, Biologics Quality Assurance Compliance Management. He continued to advance as Director, Third Party Manufacturing Biologics Quality Operations and as Director, Biologics External Manufacturing Quality Compliance until 2020. Currently, he is the Director, Global Regulatory Sciences CMC Operations and Intercon Support.
Education and Expertise
Brett Budis holds a Doctor of Philosophy (Ph.D.) and a Master of Science in Chemical Engineering from Lehigh University. He earned his Bachelor of Science in Chemical Engineering from Lafayette College. His expertise includes quality oversight for biologics drug substances, managing health authority inspections, and leading inspection readiness teams for CMOs. He has significant experience in tech transfer, qualification of new facilities and equipment, validation of processes, and licensure of biologics drug substances.
Achievements
Throughout his career, Brett Budis facilitated three general GMP and eleven Pre-Approval Health Authority inspections, which resulted in product approvals. He has 16 years of experience as the Quality Lead for various critical projects, including the tech transfer and validation of biologics drug substances at commercial scales. His work spans CMOs in the US, Europe, and Asia, ensuring compliance and quality operations.