Functieomschrijving

You will be the analytical engine behind our clients' most challenging impurity investigations. You will design and execute highly sensitive mass spectrometry methods to ensure the safety and compliance of pharmaceutical products.

• Design, develop and validate sensitive and robust analytical methods for trace-level analysis quantification (with a primary focus on nitrosamine and NDSRI’s) using LC-MS/MS and HRMS, in compliance with ICH, FDA, and EMA guidelines.
• Perform complex sample preparation and analysis in diverse pharmaceutical matrices, applying expertise in mass spectrometry (Triple Quadrupole, HRMS), chromatographic separation (UHPLC) and sample preparation.
• Design robust extraction and sample clean-up strategies (e.g., SPE, liquid-liquid extraction) to overcome severe matrix effects in complex drug products, while strictly preventing artifact generation during analysis.
• Conduct and support root cause investigations related to impurity formation, focusing on chemical pathways, impurity profiling, and risk assessment across drug substance and drug product development.
• Deliver data and reports according to high scientific and quality standards. Contribute to method transfer and GMP documentation.
• Promote innovation by exploring novel analytical approaches and emerging technologies to enhance detection limits and method robustness.
• Support lab operations in full compliance with GMP and data integrity standards.
• Interact with our clients to discuss scientific aspects.
• Represent Anabiotec/anacura in internal and external scientific forums and scientific conferences.