Principal Scientist, Immunogenicity and Ligand Binding Assays

1000scholars; Oxford; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Moderna in Oxford, United Kingdom, seeks a Principal Scientist in Immunogenicity and Ligand Binding Assays to lead LBA-based bioanalysis for the mRNA-LNP pipeline. You will guide immunogenicity strategy, oversee ADA/neutralizing antibody assays, and ensure GLP/GcLP compliance across the team.

You will work with cross-functional teams to drive assay development, validation, sample analysis, data interpretation, and regulatory support throughout clinical development, leveraging modern analytics

Qualifications

• PhD in infectious disease, immunology, cancer biology or related field with 10+ years in biotech/pharmaceutical industry.
• MS with extensive bioanalytical experience accepted.
• Experience with RNA, biologics and cell therapy preferred.
• Experience with platforms such as ECL, Gyrolabs, DelPhia and reporter gene assays for clinical work.
• Ability to communicate scientific concepts and program objectives in a matrix environment.
• Knowledge of GLP requirements and regulatory expectations for bioanalytical science.
• Experience with Watson LIMS and LabVantage eLBN is advantageous.

Responsibilities

• Provide scientific and hands-on oversight of LBA-based bioanalyses supporting Moderna’s development programs.
• Lead and oversee ADA and neutralizing antibody assay development, validation and clinical testing.
• Ensure GcLP compliance across the LBA team and laboratory practices.
• Design and execute phase-appropriate clinical analytical strategies across various assay types.
• Review raw data, validation data, and study reports for quality and regulatory alignment.
• Collaborate with internal and external stakeholders to support regulatory submissions.

Skills

RNA experience

Biologics

Cell therapy

Assay platforms

Communication skills

GLP knowledge

LIMS Watson

LabVantage eLBN

Education

PhD in immunology/related

MS in bioanalytics

Tools

Watson LIMS

LabVantage eLBN

DelPhia

Gyrolabs

ECL

Job description

# Principal Scientist, Immunogenicity and Ligand Binding AssaysModernaOxford, United KingdomResearcher / ScientistImmunologyProteinsNo deadline given## About the positionPrincipal 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. The key Moderna Mindsets you’ll need to succeed in the role: We obsess over learning. We don’t have to be the smartest we have to learn the fastest. We act with dynamic range, driving strategy and execution at the same time at every step. 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 companythat is Bold, Relentless, Curious, and Collaborative. Apply Now Don't forget to mention EuroScienceJobs when applying.