Director CMC Analytical

In partnership with a clinical-stage biotech in Utrecht heading into patient studies, we are looking for an experienced analytical leader. You will set the analytical strategy for a molecule with both binding and enzymatic activity to characterize, at the point where the decisions you make will carry it through late-stage development and towards commercial filing. You’ll own analytical development and control for Drug Substance and Drug Product, reporting to the VP CMC.

That means: building the analytical development and control strategy for a complex biologic, from clinical stages through to late-stage and commercial readiness; acting as technical lead for method development, qualification, validation and transfer; overseeing characterisation, stability and release testing programmes; setting specifications and shelf life based on release and stability data and trending; managing analytical work at CDMOs and holding partners to high scientific and quality standards; authoring and reviewing the analytical sections of regulatory filings (IND, IMPD, briefing packages) and contributing to agency interactions; supporting manufacturing investigations and root cause analysis; introducing new analytical technology and QbD approaches where they add value; working closely with CMC, Clinical, R&D, Quality, Regulatory Affairs and Manufacturing & Supply.

What you bring: a PhD or MSc in Analytical or Biochemistry, Pharmaceutical Sciences or a related field, with 10+ years in analytical development in biotech or pharma, including a leadership role; hands-on depth in method development and validation for biologics DS and DP; a track record of managing CDMOs and building partnerships that deliver; experience across early and late-stage development, ideally through to launch; solid knowledge of ICH, FDA, EMA and GMP requirements for development, release and stability.

What's in it for you: analytical ownership of a complex fusion protein, with both binding and enzymatic activity to characterize; the chance to shape the control strategy ahead of late-stage development and commercial scale-up; a well-funded company backed by leading European life sciences investors; an entrepreneurial, high-pace environment, reporting directly to the VP CMC.