Global Director, Process and Manufacturing Technology
Joseph Micsko is a Global Director Process Manufacturing Technology, where he oversees various projects for Biotech/Pharma clients. He has a wealth of knowledge and experience with over sixteen (16) years in the Pharma/Biotech Industry especially in Single Use Technology (SUT) and Cell and Gene Therapy (CGT) Startups. Joseph manages the development and implementation of process improvements designed to achieve greater efficiency in overall Business Operations. He is a subject matter expert in CIP systems, Chemical Distribution Skids, Upstream and Downstream Processing, Single use systems, Autoclaves and Steam-in-Place (SIP). He has extensive knowledge of planning, coordinating, and executing Cleaning Validation Programs to verify compliance and absence of cross-contamination. Joseph has experience with Quality Risk Management (QRM) specifically in process risk and control strategies. He has successfully managed and led diverse teams across the globe delivering numerous Pharma/Biotech projects. Joseph has extensive knowledge in Quality Management Systems, specifically in eQMS & Audit software where he was responsible for sales and implementation in APAC. He was also the APAC quality management representative with some of his responsibilities included hosting and conducting ISO9001 audits, quality management reviews and gap analysis. Joseph was the system administrator of his company’s eQMS software and implemented various process improvements/changes that were translated from paper-based to enterprise systems.