Experience Leader who drives successfully changes across borders and hierarchy levels. Leading the accelerated growth of Wacker Biotech - Wackers BioPharma CDMO activities, with more than 23 years of experience in business and technical operations. In depth M&A, Due Dilligence and Integration experience with current focus on change management, people & organisational development. Overseeing the performance of our four GMP manufacturing sites in Germany (Jena/Halle), the Netherlands (Amsterdam) and in the United States of America (San Diego).
Strong hands-on experience in complex biopharmaceutical projects, CMC Management, bioprocess development, cGMP -manufacturing for clinical studies as well as for commercial products, quality control and quality assurance for biopharmaceuticals or biologics derived from mammalian or microbial expression systems.
Scientific focus on advanced medicines, pDNA, mRNA and recombinant proteins & antibodies, antibody derived molecules (e.g. ADCs, Fabs, scFv), experience in very large scale production; Scale up and down for upstream and downstream processes, analytical method development and validation
Transfer of biotech processes and methods, Multi-Product-Facility Design, Technical engineering for large scale fermentation and cell culture including Single Use equipment, manufacturing collaborations, FDA and EMA regulatory experience, IND/IMPD BLA filing processes, change control in late stage for biopharmaceuticals, Product development in big pharma and Project management in late clinical phases