Principal Scientist, Immunogenicity and Ligand Binding Assays
Core
Lead scientific strategy and hands-on oversight of immunogenicity and ligand binding assays (LBA) for Moderna's mRNA-LNP therapeutic pipeline, ensuring regulatory compliance and data integrity for clinical development.
Role type
Principal Scientist, Clinical Bioanalysis (Immunogenicity & LBA)
Builds
Regulated bioanalytical assays (ADA, neutralizing antibody, PK, PD) and clinical data packages for mRNA-LNP therapeutics.
Domain
Biopharmaceuticals / mRNA therapeutics / Clinical Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Immunogenicity assay design, Ligand binding assay (LBA) development, Anti-drug antibody (ADA) assay validation, Neutralizing antibody assay execution, GLP/GCP compliance, Regulatory submission support, Data interpretation, Risk-based decision making, Cross-functional collaboration
Preferred skills
RNA biology, Biologics, Cell therapy, ECL/Gyrolabs/DelPhia platforms, Watson LIMS, LabVantage eLBN
Technologies
ECL, Gyrolabs, DelPhia, Watson LIMS, LabVantage eLBN
Responsibilities
Lead and facilitate regulated method development and validation for ADA and neutralizing antibody assays; Design and execute phase-appropriate clinical analytical strategies; Review and evaluate raw analytical data and study reports for scientific integrity; Ensure GcLP/GLP/GCP compliance across laboratory systems and procedures; Collaborate with stakeholders to support clinical bioanalytical activities throughout the product development lifecycle; Contribute to regulatory submissions and responses to authority questions.
Seniority
Principal, hands-on IC with strategic leadership
