Principal Research Associate, Clinical Biomarker Laboratory
Core
Develop, qualify, and validate ligand-binding and cell-based assays for biomarker and immunogenicity testing to support Moderna's vaccine clinical development programs.
Role type
Senior IC clinical laboratory research associate (quality & data focus)
Builds
Regulated bioanalytical data and quality management systems for infectious disease, oncology, and autoimmune disease programs
Domain
Biopharmaceuticals / Clinical Laboratory / Vaccine Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Immunoassay development, Cell-based assay execution, GLP/GCP compliance, Quality data analytics, SOP development, LIMS data management, Document control, Risk assessment
Preferred skills
Virus neutralization assay experience, Functional antibody assay experience, Bioanalytical method validation, Data management planning, Lab automation, Statistical analysis
Technologies
LabVantage LIMS, Excel, Microsoft Office Suite
Responsibilities
Develop analytical quality data standards per GLP/ICH/GCP, oversee daily data quality procedures, evaluate performance risks against regulatory expectations, lead quality metrics reporting, manage document versioning and training, support QC review of clinical assay data, produce training manuals for staff
Seniority
Senior, hands-on IC