Dr. Karlheinz Landauer

Karlheinz is a GMP person, working regularly with guidelines from EU, US, ICH but also WHO and guidelines from development countries. Understanding the needs of the customers as well as the regulators and understanding of the processes leads to efficiently working with the guidelines while keeping a close eye on implementing them efficiently and in a practical way. After his PhD in the field of animal cell culture medium development, he took his first job in a cancer-therapy company and was finally promoted to Head Manufacturing. Later he took the opportunity to take a job at Celltrion, South Korea followed by a CDMO in Basel. He was Head Manufacturing and COO. After 9 years of employment at CMOs , he decided to take the next step. In January 2016, he has founded QBDC, with the core focus on consulting biotech and pharma companies in CMC matters as process development, technology transfer and scale-up, facility layout and design as well as project management and quality management and assurance. Additionally to that we are developing Excel-based cGMP solutions with the goal to increase operational efficiency at our customers and to comply with the newest regulations in this field. Karlheinz has specialized on quality management, facility design and qualification, on up-stream process development, scale-up and tech transfer strategies as well as GMP operations. He was a project team member and a project manager to set-up and implement GMP Quality Management and Assurance Strategies including a new DP Facility in Saudi Arabia as Managing Director Quality Operations.