Principal Scientist, Immunogenicity and Ligand Binding Assays

Principal Scientist, Immunogenicity and Ligand Binding Assays

Moderna

Oxford, United Kingdom

The Role:

This role sits at the forefront of Moderna’s clinical bioanalytical strategy, providing deep scientific expertise and hands-on leadership across immunogenicity and ligand binding assay (LBA) bioanalysis for our mRNA-LNP therapeutic pipeline. As an individual contributor, you will shape and execute phase-appropriate bioanalytical strategies that enable critical clinical development decisions while ensuring the highest standards of scientific rigor and regulatory compliance.

Working closely with cross-functional development teams, you will drive regulated immunogenicity and bioanalytical activities spanning assay development, validation, sample analysis, data interpretation, and regulatory support. You will play a pivotal role in advancing innovative medicines through clinical development while leveraging modern digital capabilities and emerging analytical technologies, including opportunities to work alongside advanced data and AI-enabled approaches that accelerate scientific insight generation.

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.

Here’s What You’ll Need (Basic Qualifications):

• A Ph.D. in infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 10+ years of industry biotech/pharmaceutical experience. M.S. with extensive bioanalytical experience are considered.
• Experience with RNA, biologics and cell therapy preferred.
• Experience of various platforms such as ECL, Gyrolabs, reporter gene assays, DelPhia assays and other methodologies for clinical assays.
• Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment.
• Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.
• Experience on Watson LIMS and LabVnatage eLBN would be an advantage.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.