Schlieren, Zurich, Switzerland
Innovative, result-driven and team-oriented professional with nearly 20 years of experience in the Discovery & Development of novel biotherapeutics and biosimilars within the pharmaceutical industry. AREAS OF EXPERIENCE 1) Regulatory Affairs: • Regulatory Affairs CMC life-cycle management of biologics, e.g. major marketed brand Cosentyx and a drug product brand in clinical development. 2) Analytics: • Protein-and Bioanalytics, encompassing a wide range of analytical techniques. Development and implementation of analytical methods and analytical strategies. Method validation. Method transfers. Expert in in- & ex-vivo stability assessment (incl. PK and immunogenicity), ligand-binding, affinity & kinetics and cell-based assays. • Managing of therapeutic projects (mAbs, ADCs, therapeutic proteins) in research and early development phases. • Leadership and communication skills, including experience in managing and mentoring laboratory teams and collaborating with multidisciplinary and CMC teams. KEY ACHIEVEMENTS • Prepared major line extensions (US, RoW) and variations (manufacturing site transfers, scale-ups, shelf-life extensions, changes to specifications) for marketed brand Cosentyx, contributing to continuous market supply, increased patient access, and reduced manufacturing costs. Planned, authored and coordinated submissions. Authored CMC documentation for Health Authority submissions, incl. responses to HA questions. Prepared CTD dossier, incl. Module 3 Quality documentation, supporting lifecycle management and BLA/MAA submissions. • Let the "In-vivo Fitness Assessment" and "Kinetics & Affinity" laboratories, successfully contributing to the identification, characterization, and selection of new biotherapeutic drug candidates. Developed and established new analytical assays, analytical technologies and solutions for lab automation. • Developed bioassay strategies and bioassays for biosimilars, facilitating the expansion of a strong pipeline and enhancing patient access to medicines. • Managed the developability assessment for several biotherapeutic projects, contributing to a successful transition of novel drug candidates from research to technical development. • Led a workstream to define and implement an analytical strategy and analytical methods for Adeno-Associated Viruses, facilitating the successful implementation of a new AAV platform.
Leading Athebio’s Protein Science Group, contributing to the generation of Athebody® DARPins - a next-generation protein scaffold that empowers drug developers to create novel biotherapeutics with exceptional specificity, efficacy, and safety.
Regulatory submissions and life-cycle management for marketed drug product Cosentyx and product in development phase. Major line extensions (US and RoW), major variations (site transfers, scale-ups, shelf-life extensions, changes to specificaitons), authoring of CMC documentation for Health Authority submissions (responses to questions) and NDA/MAA.
Providing profound bioassay expertise and bioanalytical support contributing to the establishment of a robust biosimilar pipeline and enhanced patient access to medicines.
Driving the developability assessment of novel drug candidates in various roles (lab head, project representative, senior analytical expert, screening & production expert) to contribute to a successful transition of novel biotherapeutic drug candidates from research to technical development.
Member of the commercial production team for Herceptin drug substance.