Stijn Claerhout

CMC Leader | Small Molecules & Advanced Therapies | CDMO Strategy & Execution | Cross-functional Leadership | Pharma & Biotech

Antwerp Metropolitan Area

About

CMC leader with 10+ years of experience in biopharma, specializing in drug substance development and CMC leadership across multiple modalities, including small molecules, Cell & Gene Therapy, peptides, and lentiviral vectors. Proven track record in delivering IND/CTA submissions and leading cross-functional global teams and CDMO networks in fast-paced environments. Strong expertise in CMC strategy, external manufacturing, tech transfer, and regulatory alignment, with a focus on clinical readiness and operational excellence. Recognized for building high-performing teams and driving execution of complex programs from early development through clinical readiness.

Experience

  • Galapagos (7 yrs 2 mos)
    • CMC Project Lead (Cell Therapy)
      Nov 2023 - Mar 2026 · 2 yrs 5 mos

      Leading cross-functional CMC teams in the development and execution of CMC strategies for innovative Cell & Gene Therapy programs. Responsible for end-to-end CMC delivery.

    • Associate Director, Drug Substance Development
      Feb 2019 - Nov 2023 · 4 yrs 10 mos

      Led drug substance development across small molecules and lentiviral vectors, supporting multiple clinical-stage programs. Focused on delivering high-quality CMC packages and ensuring reliable clinical supply through effective CDMO network management. Key contributions: Managed a global CDMO network (10–15 partners) Delivered drug substance for 10+ (pre)clinical programs with 100% on-time milestones Led development activities including solid-state (small molecules) and LVV (plasmids, cell banks, manufacturing readiness) Contributed to IND/CTA submissions and regulatory responses

  • Project Manager at Corden Pharma - Peptisyntha
    Oct 2015 - Nov 2018 · 3 yrs 2 mos

    Managed peptide API development programs from early development through GMP manufacturing. Acted as key interface between internal teams and external partners to ensure timely and high-quality delivery. Key contributions: Designed and executed peptide process development (liquid & solid phase synthesis) Delivered multiple tech transfers and GMP batches Coordinated external analytical activities (method development, validation, impurity profiling) Supported GMP manufacturing, including deviations and validation documentation

  • Manager analytical laboratory at Umicore
    Sep 2013 - Jun 2015 · 1 yr 10 mos

  • Process Chemist at Eastman Chemical Company
    Nov 2012 - Jul 2013 · 9 mos

    Worked on process improvement of polyvinyl butyral (PVB) manufacturing for laminated safety glass (Saflex® interlayer). Key contributions: Improved manufacturing processes to enhance efficiency and product quality

  • Postdoctoral researcher (Marie-Curie Fellow) at IECB - Institut Européen de Chimie et Biologie
    Apr 2010 - Oct 2012 · 2 yrs 7 mos

    Conducted advanced research in organic chemistry, focusing on synthetic methodologies and catalysis. Key contributions: Developed innovative approaches in synthetic chemistry Collaborated in an international research environment