Mitch Lesiuk
About Mitch Lesiuk
Mitch Lesiuk is the Manager of Quality Engineering and Validation at Bristol Myers Squibb, with over 20 years of experience in large-scale GMP production.
Current Role at Bristol Myers Squibb
Mitch Lesiuk serves as Manager Quality Engineering and Validation at Bristol Myers Squibb. In this role, he provides quality oversight for process validation programs involving seven commercialized monoclonal antibodies. He also leads a team responsible for overseeing process, equipment, facility, and environmental validation, ensuring the robustness of the Quality Management System.
Previous Position at Juno Therapeutics, Inc.
Before joining Bristol Myers Squibb, Mitch Lesiuk worked at Juno Therapeutics, Inc. as a Senior Specialist in Quality Engineering. During his tenure from 2018 to 2020, he operated out of Bothell, Washington. His role focused on supporting quality engineering activities within the company's manufacturing operations.
Career at Genentech
Mitch Lesiuk had a long tenure at Genentech, spanning from 1999 to 2018. He initially served as a Quality Assurance Associate in Manufacturing QA from 1999 to 2001, followed by roles including Senior Supervisor in Manufacturing Quality Assurance for six years, and finally, Senior Technical Manager in Quality Engineering Validation for 11 years. His work was based in Vacaville, CA, where he contributed extensively to quality engineering and validation processes.
Experience at ALZA Corporation
From 1995 to 1998, Mitch Lesiuk held the position of Quality Assurance Specialist at ALZA Corporation in Vacaville, CA. During this period, he focused on maintaining quality assurance standards in the manufacturing process, helping to ensure that products met rigorous GMP requirements.
Education and Background
Mitch Lesiuk obtained his Bachelor of Science degree in Cell/Cellular and Molecular Biology from Humboldt State University. His academic background laid the foundation for his extensive career in quality engineering and validation, especially within large-scale GMP production environments.
Industry Expertise and Collaboration
With over 20 years of experience in large-scale GMP production, Mitch Lesiuk brings a wealth of industry expertise. He collaborates closely with Engineering and Development stakeholders to ensure that quality standards are upheld in process validation programs. His experience in managing and leading quality oversight teams makes him a valuable asset in maintaining high standards in pharmaceuticals manufacturing.