Würzburg, Bavaria, Germany
- End-to-End Project Delivery: Leading the full lifecycle of downstream process scale-ups (10L to 3000L), managing the transition from clinical phases to market authorization and commercial GMP manufacturing. - Team & Resource Management: Provide strategic direction and technical leadership to multidisciplinary teams of engineers and operators. - Stakeholder Management: Serve as the single point of contact for international customers and project relevant departments - Regulatory & Compliance Oversight: Managing the DSP documentation pipeline, including the authoring of validation protocols and reports essential for successful regulatory filings and commercial phase operations. - Risk Management: Managing risk assessment strategies for process changes, deviations, out-of-specifications, CAPAs and other events, ensuring mitigation without impacting critical timelines or regulatory compliance. - Operational Excellence: Drive digital transformation initiatives by leading a project to automate data visualization, reducing manual reporting time and increasing data integrity.
Lecture in the module “Comprehensive Biotechnology” on production and purification of antibodies and introduction to novel therapies such as mRNA and cell & gene therapy
- Protein expression in E.coli and purification via FPLC (ÄKTA) - Characterization and functionalization of therapeutic proteins and site-specific modification with polymers and small molecules - Functional protein testing in in vitro bioassays - Design of novel transdermal therapeutic system - 3D bioprinting - Supervision of interns, bachelor and master students
Establishment of a perfusion reactor system with 3D printed scaffold inserts for the cultivation of hematopoietic cells and optimization by means of simulation
- Technical support - Resin-lifetime-studies - High-throughput optimization of antibody purification process