As an MSAT Scientist, you will be responsible for leading analytical method transfer and validation activities for commercial and pipeline biologics manufacturing processes. You will combine hands-on laboratory work with scientific data analysis, technical writing and cross-functional project support.
This is a highly visible role where you'll have the opportunity to take ownership of critical analytical projects while continuously expanding your expertise in biologics characterization and analytical sciences.
Key responsibilities
- Lead analytical method transfer and validation activities
- Own and drive analytical method transfer and validation projects from initiation through completion.
- Develop and execute validation and transfer strategies in accordance with ICH, USP and Ph. Eur. requirements.
- Design and perform analytical studies supporting content, potency and impurity testing.
- Investigate analytical deviations, troubleshoot method performance issues and perform root cause analyses.
- Collaborate with MSAT, QC, development teams and external partners.
- Present project updates, scientific data and conclusions to stakeholders.
Grow as a technical expert
- Build deep expertise in analytical methods, products and instrumentation within your area of responsibility.
- Serve as a subject matter expert for technical, scientific and regulatory questions.
- Stay up to date with emerging technologies, scientific literature and industry best practices.
- Support continuous improvement initiatives and innovation projects.
Ensure quality and compliance
- Author and review SOPs, study protocols and technical reports.
- Document experiments in electronic laboratory systems while ensuring data integrity compliance.
- Perform data trending and statistical evaluation of analytical method performance.
- Review data packages and reports with a critical scientific mindset.
- Ensure compliance with cGMP requirements and regulatory expectations.
Support laboratory operations
- Execute analytical testing using techniques such as ELISA, receptor binding assays, qPCR, electrophoresis and spectroscopy.
- Perform laboratory troubleshooting and routine equipment maintenance.
- Support small-scale testing activities.
- Contribute to a safe, compliant and well-organized laboratory environment.
Required qualifications
- PhD in Biotechnology, Biochemistry, Life Sciences or a related scientific discipline.
- Proven experience with analytical method validation and/or method transfer within biologics, biotechnology or biopharmaceutical environments.
- Hands-on experience with ELISA, protein binding assays and spectroscopic techniques.
- Strong understanding of cGMP and regulatory requirements for analytical testing.
- Familiarity with ICH guidelines, USP and Ph. Eur. requirements.
- Experience writing scientific protocols, validation documentation and technical reports.
- Strong analytical thinking and problem-solving skills.
- Ability to independently manage multiple priorities and projects.
- Experience with statistical data analysis and interpretation of analytical method performance.
- Interest in digitalization, automation and innovative technologies, including AI-supported analytical workflows.
Preferred qualifications
- Experience with automated liquid handling platforms such as Tecan, Hamilton or Andrew.
- Knowledge of protein characterization techniques such as DLS, DSF, CD, AUC or Western Blot.
- Experience applying Design of Experiments (DOE) principles.
- Previous experience in a GMP-regulated biopharmaceutical environment.
Languages
- Fluent in English, both written and spoken.
- Dutch is an asset, as you will work closely with local teams in a predominantly Dutch-speaking environment.