Our client, a leading biopharmaceutical organization, is seeking an expert to join their analytical science and technology department. The role focuses on driving analytical excellence by developing and implementing critical methods to ensure the quality and consistency of cell culture-based manufacturing processes.
- Act as a technical expert for analytical qPCR and ELISA methodologies.
- Execute method handovers from research to manufacturing science, ensuring comprehensive documentation and knowledge transfer.
- Coordinate the transfer of validated analytical methods to quality control, including troubleshooting and writing of protocols and reports.
- Design, develop, and validate analytical methods for both existing and new production processes.
- Independently design experiments and develop comprehensive analytical studies.
- Perform data trending and monitoring of analytical methods to ensure long‑term reliability and effectiveness.
- Conduct root cause investigations for analytical deviations and present findings to the technical team.
- You possess a PhD in Life Sciences, Biochemistry, Biotechnology, or equivalent through experience.
- You bring proven experience in analytical method development, qualification, and validation within a cGMP environment.
- You have strong hands‑on expertise with qPCR and ELISA, specifically for host cell impurity analysis.
- You have experience designing and executing DOE experiments for the qualification of analytical assays and interpreting complex datasets.
- You're an analytical problem‑solver with strong technical writing skills and the ability to manage multiple projects.
- You are fluent in English with a good knowledge of Dutch.
Nice to Haves
- Knowledge of protein characterization techniques such as SDS-PAGE or Western/Southern/Northern blots.
- Willingness to support both laboratory-based testing and desk-based analysis.