Job description
Your Mission
Join our Scientist GMP analytical team to develop, validate, and transfer using Liquid Chromatography (LC) method 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:
• 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.
• Proven track record in industry with 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.