Associate Scientist II, Clinical QC - GMP Sample Management and Testing ADQC

Job description

Are you ready to turn rigorous GMP sample management and clinical QC testing into faster, confident decisions for people living with rare diseases? In this role you will sit at the heart of our biologics development engine, ensuring every sample is accounted for, every test is executed to standard, and every data point moves our pipeline from early stage through Phase III with speed and integrity. You will lead the flow of clinical stability and release samples from shipment to result, bringing discipline to gLIMS/sample management and precision to compendial testing. By collaborating across development, clinical supply, manufacturing, quality and external partners, you will translate laboratory excellence into reliable batch release and stability insights that optimize processes and protect patients. Can you spot a trend in stability data and act before it becomes a deviation? Accountabilities: GMP Sample Management and Logistics: - Own receipt, inventory, chain-of-custody and gLIMS data entry for GMP samples; manage compliant shipping/receiving, including temperature-controlled logistics; keep audit-ready records that withstand internal and external scrutiny. Clinical Stability O...