Process Development Associate – Large Molecule Release Testing, Pre-Pivotal Attribute Science

Role: Process Development Associate specializing in Large Molecule Release Testing within Amgen’s Biotech pipeline. Primary focus on defining critical quality attributes, advancing analytical tools, and supporting product characterization and stability. Responsibilities include executing and troubleshooting compendial methods (protein concentration, pH, chromatography, electrophoresis), supporting method transfer and qualification, maintaining documentation per GxP standards, and participating in investigations and regulatory submissions. Additional duties involve laboratory maintenance, inventory management, and calibration activities. Qualifications: Bachelor’s degree in Life Sciences or related field; ideally with GxP experience, expertise in chromatography and capillary electrophoresis, and strong documentation skills. Preferred: background in cell biology, biochemistry, or biomedical engineering, with experience in analytical method development and validation. High-value specifics include focus on large biologics, early-phase (pre-pivotal) development, compliant with GMP, and supporting regulatory submissions. Collaboration spans product and process development, quality, and analytical teams. Work environment is laboratory-based, with potential for cross-functional interaction; travel not specified.