Brett Budis

About Brett Budis

23 years of experience in the biopharmaceutical industry including supervisory roles within Manufacturing and Quality Assurance• 16 years experience as the Quality Lead for the tech transfer, qualification of new facilities and equipment, validation of processes, and licensure of biologics drug substance, primarily at Contract Manufacturing Organizations (CMOs). Includes 4 years experience with Quality Operations and lot disposition of commercial biologics drug substance manufactured at CMOs. Experience includes quality oversight for up to 6 concurrent biologics drug substances manufactured by microbial (up to 40k scale) and mammalian cell culture (up to 25k scale) at CMOs located in US, Europe and Asia for clinical and commercial supply. • 13 years experience in leading cross-functional inspection readiness teams for CMOs and serving as front room facilitator for three general GMP and eleven Pre-Approval Health Authority inspections. Each of the Pre-Approval inspections resulted in product approval.

Experience

1. Vice President, Global Project Management

   LOTTE Biologics

   Aug 2024 — Present · Syracuse, NY, US

Education

• Lafayette College

  BS, Chemical Engineering

  1983 — 1987

• Lehigh University

  M.S., Chemical Engineering

  1987 — 1990

• Lehigh University

  Doctor of Philosophy (Ph.D.), Chemical Engineering

  1990 — 1994

Skills

• Gmp
• Quality System
• V&V
• Cleaning Validation
• Fda
• Biotechnology
• Capa
• Validation
• Biologics
• Cmc
• Biopharmaceuticals
• Quality Assurance
• Technology Transfer