Jeske Smink
Senior Director Cmc, Head of Cmc @Aicuris Anti-Infective Cures Ag
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WORK HISTORY
Senior Director Cmc, Head of Cmc @Aicuris Anti-Infective Cures Ag
Aicuris develops novel anti-viral therapies for patients with weakened immune systems. The pipeline includes the late-stage candidate pritelivir, a small molecule, which targets refractory and resistant HSV infections in vulnerable patient populations. An antisense oligonucleotide candidate designed specifically to treat reactivation of the BK virus (BKV) in kidney transplant recipients, is currently in early-stage clinical development. At AiCuris, I lead CMC development of the different therapeutic modalities throughout the different clinical phases. I’m responsible for the strategic and operational oversight of the different activities including manufacturing, but also CMC regulatory activities. Key responsibilities include - Overseeing CMC development for an oligonucleotide program (Clinical Phase 2) and small-molecule programs (Clinical Phase 3 and NDA/MAA), including scale-up activities, GMP manufacturing, and CMO management- Leading a cross-functional CMC team and responsibility for budgeting and project planning across the different modalities and clinical phases- Contribute to and review regulatory CMC dossiers, including Quality sections of IND/IMPD/NDA filings and briefing documents- Serving as the company’s CMC representative, specifically for the oligonucleotide program, in managing interactions with CMOs and strategic partners
EDUCATION
Utrecht University
BSc and MSc, Biology
SKILLS
ABOUT JESKE SMINK
Summary:CMC Development Oligonucleotides BiologicsCell Therapy Scientific, technical and manufacturing expertiseSpecialties:CMC, Process & Analytical Development, Manufacturing, GMP, Quality, Operational expertise, Project management, Team management, Strategic thinking, Regulatory documents, Cross-functional collaboration, Stakeholder management, Molecular & Cellular Biology
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