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Sr. Scientist - Small Molecules (Analytical)
For our client a developer of innovative therapies and precision medicine, we’re looking to recruit a Senior Scientist – Small Molecules (Analytical) to act as SME for small molecules in the entire organisation. This position is specifically interesting as you will operate at the intersection of science, CMC strategy and regulatory execution, shaping analytical development from early clinical phases through to commercial readiness.
Biotechnical
R&D
Leiden - Netherlands
40 hours per week
Get to know
Your consultant
About your role
This is how you will make the difference
- Independently design, develop, transfer and validate advanced analytical methods for Drug Substance and Drug Product
- Ensure analytical methods are robust, transferable and fit-for-purpose across clinical and commercial phases
- Lead and manage external contract laboratories and manufacturing organisations for method development and routine testing
- Represent Analytical Small Molecules within CMC teams and align analytical strategy with overall CMC objectives
- Generate high-quality scientific documentation, reports and presentations for internal and external stakeholders
- Contribute to regulatory submissions (IMPD, IND, NDA, MAA) and respond to complex regulatory questions
- Own deviations, CAPAs and major changes, providing scientific troubleshooting and innovative solutions
- Mentor scientists and support knowledge transfer to internal and external stakeholders
what's needed
What you bring
- A PhD or MSc in Pharmaceutical Sciences, Analytical Sciences, Biochemistry or related field
- 10 years of relevant experience, including >5 years in biotech/pharma focused on Analytical Small Molecules
- Strong expertise in analytical method development, transfer and validation for small molecules
- Experience working with and managing CxOs in a GMP-regulated environment
- Solid understanding of EMA, FDA, ICH guidelines and cGMP requirements
- Proven project management experience, with the ability to balance timelines and budgets
- Experience contributing to regulatory dossiers and interacting with health authorities
- Excellent communication skills in English, both written and verbal
What we offer
What's in it for you
- A visible and influential role within global CMC project teams
- The opportunity to shape analytical strategy across multiple small molecule programmes
- Exposure to both clinical and commercial development phases
- Close collaboration with international CxOs and regulatory stakeholders
- A culture that values ownership, scientific depth and continuous learning
- Competitive compensation aligned with seniority and expertise
- A collaborative biotech environment with short communication lines
- Long-term growth potential within an expanding rare disease portfolio
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