Responsibilities
- Develop, optimize, and transfer analytical or process methods such as LC-MS, HPLC, and chromatographic separations.
- Act as a subject-matter expert for analytical or process domains, providing technical support and troubleshooting.
- Support technology transfer of products from development to GMP manufacturing scale, including documentation and control strategies.
- Lead improvement initiatives to increase yield and process robustness while building supportive data packages.
- Conduct root cause investigations and impact assessments for product, process, or method-related issues.
- Collaborate cross-functionally with lab, manufacturing, and quality teams to maintain a compliant work environment.
- Master or PhD in Life Sciences, Chemistry, or a related field.
- You have 3 years of relevant experience in MSAT, analytical R&D, or process development.
- You bring hands-on experience with analytical techniques such as LC-MS, HPLC, Chromatography, and Mass Spectrometry.
- You possess knowledge of manufacturing processes including mammalian cell culture and biologics.
- You have a strong understanding of GMP standards and pharmaceutical testing requirements.
- You're a strong communicator with an analytical, problem-solving mindset.
- You are fluent in English with active knowledge of Dutch.
- Familiarity with regulatory frameworks such as ICH, EMA, and FDA.
- Experience with statistical and data trending tools like JMP, Statistica, Matlab, or Simca.
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