Principal Research Associate, Clinical Biomarker Laboratory

Role: Principal Research Associate in the Clinical Biomarker Laboratory supporting immunoassay and cell-based assay development for Moderna's infectious disease, oncology, and autoimmune clinical programs. Responsibilities: develop, qualify, validate, and perform clinical biomarker and immunogenicity assays, including virus neutralization and hemagglutination inhibition tests; generate high-quality, regulatory-compliant data; oversee quality metrics, document control, and SOP revisions; collaborate with cross-functional teams including biostatistics and QA; lead quality analytics and data integrity initiatives; support GLP/GxP compliance and audits. Requirements: Bachelor's/Master’s/PhD in Pharmaceutical Sciences or related; 4-8 years' experience in clinical lab settings, with expertise in immunoassays, cell culture, cytometry, and bioanalytical method validation preferred; familiarity with GxP, GLP, CAP/CLIA; knowledge of LIMS, ELN, data management standards; proficiency in Microsoft Office; strong organizational and communication skills. High-Value: focus on immunogenicity testing across clinical phases, regulated environment, biologics and vaccine modalities, clinical sample analysis. WorkSetup: 100% onsite at Moderna's location with no travel specified.