(Sr.) Scientist LC-MS - Trace level Analysis

Anacura Group; Evergem; Sur place; EUR 60 000 - 85 000; Plein temps

Résumé du poste

Anacura Group is seeking an analytical scientist to lead impurity investigations using LC-MS/MS and HRMS. You will design, validate and transfer robust methods for trace-level analysis of nitrosamines and related compounds, ensuring GMP, data integrity, and regulatory compliance.

You will interact with clients and present scientific findings at forums, contributing to method development and quality assurance across drug substances and products.

Qualifications

• Design and validate trace-level analytical methods for nitrosamines and related compounds.
• Perform complex sample preparation and analysis across pharmaceutical matrices with MS and chromatography.
• Develop extraction and cleanup strategies to overcome matrix effects while preventing artifacts.
• Conduct root cause investigations on impurity formation and risk assessment.

Responsabilités

• Deliver data and reports according to GMP standards and support method transfer.
• Promote innovation by exploring novel analytical approaches and emerging technologies to enhance detection limits and robustness.
• Support lab operations in full compliance with GMP and data integrity standards.
• Interact with clients to discuss scientific aspects and present findings.
• Represent Anacura Group in internal and external scientific forums and conferences.

Connaissances

Mass spectrometry

LC-MS/MS

HRMS

UHPLC

SPE

Sample prep

Method validation

GMP compliance

Data integrity

Scientific reporting

Outils

Triple Quadrupole

Description du poste

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.