Vienna, Vienna, Austria
• Design and scale-up of aseptic filling and freeze-drying processes • Validation/Qualification • Downstream processing of biological products
• Deviation, Change Control and CAPA Management • Head of Production (§8 AMBO 2009) • Joined the project team for the construction of a new large-scale cell culture facility with 185,000 litres of biopharmaceutical production capacity in Vienna in 2018 • Established the new team for GMP-Compliance in Manufacturing
• Process validation of aseptic fill and finish processes • Plan and organize validation activities • Perform risk assessments • Evaluate and summarize results
• Implement new aseptic processes for production of prefilled application systems • Coordinate projects from lab phase to manufacturing • Transfer and scale-up of aseptic processes • Responsible for the production of clinical trial materials • Design and evaluate lab-scale studies • Freeze-drying process development and scale-up • Evaluate and transfer new technologies and processes to production • Perform risk assessments (FMEA)
• Implement new aseptic processes for production of prefilled application systems • Coordinate projects from lab phase to commercial manufacturing • Design and evaluate lab-scale studies • Freeze-drying process development and scale-up • Transfer and scale-up of aseptic processes to commercial production lines • Responsible for the production of clinical trial materials • Create master batch records for clinical and commercial production • Validate aseptic filling and freeze drying processes • Perform risk assessments (FMEA)
• Coordinated startup and validation of new production equipment • Created validation protocols and reports • Performed process validations • Created maintenance and calibration schedules • Performed risk assessments (FMEA)
• Responsible for GMP production of clinical trial material • Scale-up of purification processes (filtration and chromatography) • Training and instruction of operators • Prepared work instructions (SOP, MBR) • Evaluated and implemented new techniques • Contributed to design of new protein purification processes and analytical methods