(Sr.) Scientist LC-MS - Trace level Analysis
Over deze vacature
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.
- 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.
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Welk salaris kan ik verwachten?
Deze vacature toont geen salaris. Vergelijkbare rollen in Gent betalen vaak rond 1 994 € (mediaan van 122 vacatures).
Hoe solliciteer ik op deze vacature?
Open de oorspronkelijke bronpagina en neem daar contact op met de werkgever. Finder rekent werkzoekenden nooit iets.
Zijn deze vacatures actueel?
Ja. Finder vernieuwt regelmatig vacatures uit openbare bronnen en verwijdert gesloten aanbiedingen.
Waar kan ik het soort dienstverband en de werkvorm zien?
De belangrijkste voorwaarden vindt u boven de beschrijving. U kunt ook gerelateerde vermeldingen openen voor ANACURA en Gent.