Head of Manufacturing, aseptic production of mesenchymal stem cell products (IMP); responsibility for the GMP-compliant manufacturing of a dimeric fusion protein (IMP), including CDMO management and manufacturing oversight, secondary packaging, and distribution to trial sites. Management of quality assurance for a dimeric fusion protein, ensuring GxP compliance and regulatory requirements, batch record review, as well as CAPA and deviation management, conducting and organizing GxP training, risk management and continuous process optimization, preparing for and supporting customer and regulatory audits, serving as deputy head of quality control, developing and validating analytical methods and assays, qualification, planning and conducting stability studies