Sr. Research Associate, Clinical Biomarker Laboratory

Moderna is seeking an experienced and highly motivated Senior Research Associate to join the Clinical Biomarker Laboratory (CBL) Immunoassay and Cell Based Assay group. This laboratory-based role will support the development, qualification, validation, transfer, and clinical implementation of cell-based assays, virus neutralization/functional antibody assays, and ligand-binding assays (LBAs) used to characterize vaccine-induced immune responses and support clinical vaccine development programs, while also contributing to biomarker and immunogenicity testing across Moderna's infectious disease, oncology, and autoimmune disease portfolio. The successful candidate will bring strong hands-on experience with mammalian cell culture, cell-based functional assays, and immunoassays and will be expected to independently execute assay development and optimization experiments, qualification/validation studies, clinical sample testing, data analysis, troubleshooting, and compliant documentation in a regulated clinical laboratory environment. Direct experience with virus neutralization or other functional antibody assays is preferred, including cell culture-based neutralization assays, reporter-based or pseudovirus neutralization platforms, and/or hemagglutination inhibition (HAI) assays. Experience with ligand-binding platforms such as ELISA or electrochemiluminescence-based assays is also highly desirable. The Senior Research Associate will work closely with the clinical Biomarker Laboratory Immuno-Assay Lead, and also with biostatisticians, Quality/ Compliance partners, and other cross-functional stakeholders to deliver high-quality, traceable, and regulatory-compliant bioanalytical data supporting Vaccine clinical development programs. Here’s What You’ll Do: Contribute to preparation and review of assay methods, protocols, qualification/validation plans and reports, batch records, technical reports, and controlled documentation required for regulated clinical bioanalysis. Analyze assay data, identify trends or sources of variability, document investigations and troubleshooting, and partner with assay leads and biostatisticians to support scientifically sound interpretation of assay performance and clinical immunogenicity data. Perform clinical sample testing with strong attention to chain of custody, sample handling, plate maps/worklists, assay controls, repeat testing rules, data traceability, and timely delivery of high-quality results to support clinical study milestones. Execute ligand-binding assays for vaccine immunogenicity and biomarker endpoints, including preparation and qualification of critical reagents and controls, plate-based assay execution, curve fitting and data review, and evaluation of assay performance against predefined acceptance criteria. Run neutralization assays and related functional antibody assays using established viral, pseudoviral, reporter-based, or other qualified assay platforms; assess assay controls and system suitability, calculate and review neutralizing antibody readouts/titers, and troubleshoot assay performance when acceptance criteria are not met. Maintain and use mammalian cell culture systems required for functional bioassays, including cell expansion, passage, cell banking support, assay readiness assessment, and monitoring of cell performance in accordance with established procedures and biosafety requirements. Independently execute and support development, optimization, qualification, validation, transfer, and routine clinical testing of cell-based assays, virus neutralization/functional antibody assays, and ligand-binding assays supporting vaccine development programs. Develop analytical quality data standards related to GLP/ ICH/ GCP in accordance with existing SOPs across clinical studies and in collaboration with Laboratory Operations lead and scientific leaders at CBL. Responsible for gathering Quality data required to establish metrics and generate insights and daily