Job Description
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:
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