MSAT Scientist

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.