Teams at Asklepios Biopharmaceutical

Lead U.S.-based regulatory strategy for assigned gene therapy programs, driving global submissions and health authority interactions (IND/CTA/PIND), preparing regulatory documents and briefing packages, advising cross-functional teams, managing external regulatory partners, and ensuring compliance with FDA, EMA, MHRA and other agency requirements throughout clinical development.

Support MSAT process engineering for gene therapy scale-up, technology transfer, and cGMP manufacturing. Develop/qualify small-scale models, design and analyze process characterization experiments, author protocols/reports, support investigations and PPQ readiness, maintain lab operations, and communicate technical results to stakeholders.

Perform and develop immunology assays on clinical samples to assess AAV immunogenicity. Lead assay development/validation, analyze and report data, author SOPs and validation reports, manage sample workflow, maintain GxP-compliant lab practices, and train junior staff while coordinating with clinical teams.