Senior Scientist, Trace Analysis — LC-MS/MS Expert (GMP)

Anacura; Evergem; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Bike lease program

Flexible working hours

Healthy lunch

Fringe benefits

Social club

Résumé du poste

Anacura is seeking a (Sr.) Scientist in Trace Analysis based in Belgium to design, develop and validate LC-MS methods for impurity investigations in pharma products. You will work on nitrosamines-focused analyses using LC-MS/MS and HRMS, ensuring compliance with ICH/FDA/EMA guidelines.

You will join a dynamic CRO environment, interact with clients, and contribute to GMP documentation and data integrity while advancing novel analytical approaches. English communication is essential.

Qualifications

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or related field, or Master with relevant industry experience.
• 4–6 years of hands-on experience in pharmaceutical R&D or analytical services.
• Experience with LC-MS trace analysis in drug substances/products/excipients is a strong asset.
• Solid knowledge of mass spectrometry (QqQ, Orbitrap) and chromatography.
• Experience in method development, validation and transfer under GMP.
• Familiarity with regulatory guidelines (ICH Q2, Q3, FDA/EMA nitrosamines) and GMP.

Responsabilités

• Design, develop and validate trace-level analytical methods (LC-MS/MS, HRMS) for nitrosamines.
• Perform sample prep and analysis across diverse pharmaceutical matrices.
• Develop robust extraction/cleanup strategies to overcome matrix effects.
• Conduct root cause investigations on impurity formation and risk assessment.
• Deliver data and reports to high scientific and quality standards; assist method transfer.
• Promote innovation by exploring new analytical approaches and technologies.
• Support GMP-compliant lab operations and data integrity.
• Interact with clients on scientific aspects; represent Anabiotec/Anacura at forums.

Connaissances

LC-MS trace analysis

Mass spectrometry

Chromatography

Method development

Validation under GMP

Regulatory knowledge

English proficiency

Project management

Prioritization

Formation

PhD in Analytical Chemistry

Master degree in analytical/related field

Outils

QqQ mass spectrometry

Orbitrap mass spectrometry

UHPLC

Description du poste

Anacura is seeking a (Sr.) Scientist in Trace Analysis based in Belgium to design, develop and validate LC-MS methods for impurity investigations in pharma products. You will work on nitrosamines-focused analyses using LC-MS/MS and HRMS, ensuring compliance with ICH/FDA/EMA guidelines.

You will join a dynamic CRO environment, interact with clients, and contribute to GMP documentation and data integrity while advancing novel analytical approaches. English communication is essential.