Basel, Basel, Switzerland
- Late phase process development - Support process optimization, process characterization and process transfer
- Lead a 10 people cross-site and cross-functional TT team (Operations, Supply chain, Quality, Process Development, EHS, Engineering) to ensure the successful transfer and GMP manufacture at industrial scale - Provide budgetary and schedule estimates for the requirements of the project - Support manufacturing activities by identifying and resolving complex problems, facilitating/helping teams to resolve ambiguity resulting from rapid change - Ensure reporting to iCMC project core Team, Stakeholders, Manufacturing site management and beyond
- Developed scalable and reproducible industrial processes for production of biologics (cell culture with CHO) and small molecules (fermentation with yeasts) - Managed a team of scientists - Designed new labs and pilot facilities for cell culture (+500 m2)
- Resolved productivity issues with trials at 20L scale (media optimization with DoE) - Assisted in writing and reviewing of manufacturing batch records in accordance with cGMP standards - Supervised data process monitoring (trends follow-up, control chart)