Principal Scientist, Immunogenicity and Ligand Binding Assays

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. 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.

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 LabVantage 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.