Patrick Burke

Associate Director, Global Technology Transfer at Lonza

Speaker

Patrick is an accomplished biotechnology leader with more than 20 years of experience spanning manufacturing science and technology (MSAT), global technology transfer, quality systems, process validation, and scientific operations. He currently serves as Associate Director of Global Technology Transfer at Lonza, where he leads cross‑site harmonization initiatives, oversees complex internal and external tech transfers, and acts as a strategic MSAT liaison for commercial programs. He drives harmonized global consistency across raw materials, analytical methods, process validations, and technical transfer workflows, while serving as the technical lead for intercompany business and authoring high‑impact comparability assessments and white papers.

Previously, he managed Lonza’s Bioscience MSAT Process organization, overseeing a team of scientists, engineers, and pilot operations staff supporting media, liquid, powder, and endotoxin detection product lines. He led process validation activities from Phase I–III, scale‑up initiatives, cleaning validations, and aseptic process simulations, while ensuring alignment with site KPIs, quality expectations, and regulatory commitments.

Patrick’s earlier leadership roles in Quality Assurance and MSAT established his reputation as a subject matter expert in investigations, FDA inspections, risk assessments, and supplier audits. He has successfully supported new facility commissioning, Annex I readiness, and regulatory/customer audits, and has repeatedly delivered productivity improvements, streamlined validation programs, and ensured compliance with global standards.

His scientific foundation includes roles across QC, process development, research, and academic laboratories, with deep technical expertise in molecular biology, cell culture, assay development, and analytical testing

He holds a B.S. in Biology from Jacksonville University and is an active PDA member. He is recognized for his ability to build high‑performing teams, solve complex technical challenges, and guide organizations through regulatory and operational transformations.