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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.
Details
Biotechnical
Clinical Research
Utrecht - Netherlands
40 hours per week
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About your role
This is how you will make the difference
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's needed
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 we offer
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
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