(Sr) Scientist LC-MS Trace level Analysis

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, a family-owned, growing center of excellence in healthcare with over 300 employees consists of 4 independent business units: Labo Nuytinck, active in medical analytics and Anabiotec, OHMX.bio and Discovery Studio, active in drug development. The labs have their main activities in a state-of-art building in a green surrounding near Ghent, Belgium.

Anabiotec provides analytical services for characterization, assay development and quality assessment of novel and established medicines, ranging from synthetic molecules and biologics, to cell & gene therapies. With more than 25 years of experience we contribute to these medicines of tomorrow by helping our customers to accelerate their drug development journey. We support startups, biotech as well as large pharma companies worldwide from pre-clinical drug development, through clinical phases I, II, III all the way to commercialised treatments. We take proud in our flexibility, diligence and science thereby operating as an extension of our clients with tailored solutions and pro-active, science driven advice. To achieve all this, Anabiotec is set-up as a workspace with open doors where all our employees are encouraged to continuously improve & grow and are welcomed to actively contribute to the goals of Anabiotec.

Roles and Responsibilities

As a (Sr.) Scientist in Trace Analysis, 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.

Skills and Qualifications

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry (or a closely) related scientific field) or Master degree with at least 6 years of relevant industry experience.
• Minimum of 4–6 years of hands-on experience in pharmaceutical R&D or analytical services.
• Proven experience in LC-MS trace analysis in drug substances, drug products, or excipients is a strong asset.
• Extensive practical knowledge of mass spectrometry (QqQ and orbitrap) and chromatography.
• Experience in method development, validation, and transfer under GMP conditions.
• Familiarity with regulatory requirements (ICH Q2, Q3, FDA/EMA guidance on nitrosamines) and GMP principles.
• Excellent English communication skills (written and spoken) is required for high-quality scientific reporting.
• Demonstrated ability to work effectively in a dynamic laboratory environment to project timelines.
• Capable of prioritizing tasks across multiple urgent client projects in a dynamic CRO environment.

Offer

• You will be part of the Anacura group, a family owned, long term focused and ambitious laboratory organization.
• You will join a dynamic team and have a position with autonomy and responsibility with opportunities to take initiatives to support further growth.
• You will be offered a competitive salary with fringe benefits, a green work environment and the possibility to join our bike lease program, flexible working hours, a healthy lunch and a pleasant fun club.
• You are stimulated in your personal growth; we build on your talents in accordance with our ambitions.