Analytical Development Drug Product Production Management

Seppe De Smet

Director of Analytical Development

Seppe De Smet

Seppe De Smet is Director of Analytical Development. He leads the definition and execution of analytical strategies supporting drug product development across the full product lifecycle at Ardena. He focuses on aligning scientific, regulatory, and client needs through phase-appropriate analytical approaches, control strategies, and lifecycle management.

Throughout his career, Seppe has supported programs from preclinical development through clinical stages and commercialization, providing end-to-end analytical oversight tailored to each phase of development. He has worked across both CRO and biotech environments, combining project leadership with scientific expertise in small molecules and biologics. His experience includes method development, validation, GMP-compliant analytical operations, regulatory submissions, and CMC-related processes including manufacturing, quality control, and release testing.

Seppe earned his PhD in Analytical Chemistry with a strong focus on chromatography. At Ardena, he supports clients through high-quality and pragmatic analytical solutions designed to accelerate development timelines while ensuring product quality and regulatory compliance.