Job description
Your Mission
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.
Key Responsibilities
• 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.
Must-Have Qualifications
• 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, 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).
Why joining us?
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.