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Join our Scientist GMP analytical team to develop, validate, and transfer using Karl Fisher (measure water content in pharmaceutical raw materials, active ingredients, and finished drug products) and Liquid Chromatography (LC) methods that guarantee the purity and safety of next-generation therapies. You will own water-content testing workflows and high-resolution liquid-chromatography assays for small molecules, peptides, and oligonucleotides, ensuring every batch meets stringent regulatory standards before reaching patients.
Job Responsibility:
Karl Fischer Expertise: Design, validate, and execute KF titration methods (volumetric & coulometric) for APIs, excipients, and drug products
troubleshoot instrument drift, side reactions, and matrix effects
LC Method Development: Develop and validate U/HPLC assays for potency, impurities, and stability indicating methods
perform method transfers to QC and CMO partners
GMP Compliance: Author protocols, reports, and SOPs
review data for ALCOA+ principles
support regulatory inspections and deviations/CAPA
Cross-functional Collaboration: Partner with Process Chemistry, Formulation, and QA to align analytical strategies with project milestones
Continuous Improvement: Evaluate new KF reagents, columns, and LC technologies to increase throughput and reduce cost-of-goods
Requirements:
BSc/MSc in Chemistry, Analytical Chemistry, or related field
2+ years’ hands-on experience with Karl Fischer titration in a GMP pharmaceutical environment
Proven track record in liquid-chromatography method development and validation (HPLC/UPLC)
Strong documentation skills in English
familiarity with ICH Q2(R1), USP <921>, and FDA/EMA guidelines
Nice to have:
Experience with Empower CDS, Agilent OpenLab, or similar chromatography data systems
Knowledge of LC-MS, IC, or other orthogonal techniques
Exposure to stability studies and regulatory filings (IND, IMPD, NDA)
What we offer:
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe