| Location | Beerse, Belgium |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 27080 |
| Published | about 4 hours ago |
Location: Beerse, Belgium
Department: Advanced Material Characterization and Investigations (AMCI) / Analytical Development
Contract type: Contract
Language: English
We are looking for a skilled and enthusiastic Scientist (Project Owner) to join the Advanced Molecular Analysis (AMA) team within the Advanced Material Characterization and Investigations (AMCI) group in Analytical Development. This international and diverse team performs advanced analytical characterization of pharmaceutical products and leads global analytical investigations for both the commercial product portfolio and the Discovery, Product Development & Supply organization.
Within AMA, you will focus on designing and coordinating experiments to quantify nitrosamine impurities in different matrices and pharmaceutical products. This is a hybrid office/lab role that combines analytical design, project coordination, and close collaboration with both internal and external experts.
Design and coordinate analytical method development for nitrosamine quantification.
Develop strategies for innovative sample preparation, chromatographic separation, and detection.
Review protocols and reports from internal and external laboratories.
Coordinate with external labs to ensure right-first-time execution.
Collaborate with internal specialists and cross-functional project teams.
Communicate and report scientific results to stakeholders and project teams.
Lead analytical investigations and deviation follow-up.
Ensure compliance with GMP, safety, and relevant regulatory requirements.
PhD in analytical chemistry, pharmaceutical sciences, or a related field, or a master’s degree with at least 6 years of relevant experience.
Experience in pharmaceutical R&D is a strong advantage.
Strong planning, tracking, and project coordination skills.
Well organized and able to manage multiple priorities and resources.
Practical industry experience and knowledge of GMP regulations.
Experience in nitrosamine determination in pharmaceutical products is a clear asset.
Strong mass spectrometry experience, especially Triple Quadrupole and High-Resolution MS.
Experience with chromatographic method development.
Knowledge of regulatory frameworks such as ICH, EMA, and FDA, and GMP validation requirements.
Excellent written and spoken English.