Director
Process development
Ascendis Pharma
Denmark
"Process development and validation of chemical and enzymatic processes to small and large molecules and of downstream biopharmaceutical processes. Manufacture of small and large molecules and of biopharmaceuticals under cGMP, authorship of regulatory files for BLA/NDA and experience with inspections & audits. Leadership and management of process- and medicinal- chemistry teams and leadership of team specialized in recovery processes. Investigation Leader using A3 structured problem solving methodology. Project leadership and management of scale-up campaigns."
Process Validation, Biopharmaceuticals,