Here’s What You’ll Do

• Provide scientific and hands-on oversight of ligand binding assay (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 submissions and support responses to regulatory authority questions and information requests.
• Maintain current knowledge of emerging scientific literature, industry best practices, regulatory expectations, and evolving guidance related to clinical bioanalysis.
• Ensure adherence to Good Clinical Laboratory Practice (GcLP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs, applicable regulations, guidance documents, and relevant white papers.
• Apply scientific judgment and risk-based decision making to support robust bioanalytical strategies that accelerate development while maintaining quality and compliance.
• Partner with multidisciplinary teams to advance innovative analytical approaches and continuously improve laboratory and bioanalytical processes.