Thomas Amort

Global Project Lead for high-priority Biosimilar programs, overseeing end-to-end CMC strategy from pilot scale to BLA/MAA readiness Orchestrated IND/IMPD submissions across multiple geographies with a landmark "Zero CMC Question" outcome Lead Negotiator for FDA Briefing Books, successfully aligning innovative development paths for complex combination products Direct Leadership: Managing and mentoring a team of RegCMC Managers while leading cross-functional SMEs in a matrix environment

Spearheaded the US development Strategy for a major Biosimilar, leading successful FDA interactions as the primary CMC presenter. Strategic Consultant: Hand-picked to support an IND for a novel protein-small molecule conjugate and provided critical support for a high-profile BLA Due Diligence: Evaluated external biosimilar assets, providing critical regulatory risk assessments for potential acquisitions

Graduated with Distinction | Author of 6+ peer-reviewed publications in high-impact journals (e.g., Genome Biology, Cellular and Molecular Life Sciences) | Inventor