About this role
About the Role Principal Scientist, Immunogenicity and Ligand Binding Assays focused on LBA bioanalysis for Moderna's mRNA-LNP therapeutics. You will provide scientific leadership as an individual contributor, shaping phase-appropriate bioanalytical strategies and ensuring regulatory compliance across immunogenicity and LBA activities. What You'll Do
- Provide scientific and hands-on oversight of LBA-based bioanalyses supporting Moderna’s mRNA-LNP therapeutic development programs.
- Support and oversee the Immunogenicity function through clinical science-driven, phase-appropriate, and risk-based bioanalytical development strategies across advancing stages of clinical development.
- Lead and facilitate anti-drug antibody (ADA) assay and neutralizing antibody assay regulated method development, validation, and clinical sample testing activities.
- Ensure in-house GcLP compliance across the LBA team, systems, and procedures, maintaining rigorous laboratory practices and regulatory requirements for analytical activities through a phase-appropriate approach.
- Design and execute phase-appropriate clinical analytical strategies supporting development programs.
- Drive development, validation, and implementation of: Cell-based assays, Immunoassays, Quantitation of translated proteins, Pharmacokinetic (PK) assays, Pharmacodynamic (PD) assays.
- Review and evaluate raw analytical data, assay validation data, and study reports to ensure scientific integrity, data quality, and compliance with current regulatory, industry, and Moderna standards.
- Assess analytical performance and laboratory compliance to ensure data generated meet both scientific and regulatory expectations.
- Collaborate with internal and external stakeholders to support clinical bioanalytical activities throughout the product development lifecycle.
- Contribute to regulatory subm