Tasks and Responsibilities
Research
- University of London, UK
- University of Calgary, Canada
- Karolinska Institute, Stockholm, Sweden, as bench scientist
Industrial Research Leader
Scientist and manager of Research & Development at Boehringer Ingelheim, Germany, Hoffmann LaRoche, Nutley, NJ, USA for Microbiology, Protein Chemistry.
Industrial Manager
Manufacturing of biotech pharma products for clinical and commercial use and related disciplines like process development, scale up, Engineering and Facilities with increasing responsibilities as Senior Vice president, member of Executive Committee.
Chief Technical Officer and Board Director (Managing Director)
at
Biogen Idec International GmbH addressing novel process technologies and PAT, process and plant design with strategic directions for innovative products, lifecycle management and Biosimilars from an economic and CMC perspective, Exploration of CMC opportunities in Asia Pacific.
Quality and Regulatory Activities
- Herstellleiter for protein product release.
- Auditing internal and external operations and vendors.
- WHO expert for biological assays (IFN, and virus).
- Industrial Lead for writing group of Viral Safety Guideline in the group of 6 for International Conference for Harmonization writing the first Biotech Guidelines for recombinant protein drugs for EU, US and Japan (Q1A, Q5B).
- Company CMC technical lead for Submission, PAI and Approval at FDA and EMEA.
- Invited Expert with EBE at EMEA discussion on Biosimilars regulation in Europe, CMC expert in BIO delegation for SFDA interaction.
Lobby activities
- as Representative of company Boehringer-Ingelheim at EFPIA for biotech and Biotech environmental regulations and in Political debate around risks of recombinant DNA in the environment.
- EFPIA representative for European research Pharma Industry in International Committee for Harmonization (ICH).
- Member of PhRMA Biotech for Roche biotech.
- Early 'Cofounder' and member of BioPhorum for biomanufacturing, a small group representing > 60% of world wide biomanufacturing capacity.
Professional Societies and major events:
- Chairman of ESACT, the European Soc. Animal Cell Technology.
- Conference organizer and Scientific Advisor in many conferences like ESACT, SBE, and BioProcess/ BioManufacturing conferences organized IBC, Terrapinn, WTG etc. .
- Invited key note speaker at numerous international conferences in US, EU and Asia.