Principal Scientist, Immunogenicity and Ligand Binding Assays in Harwell

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.

Responsibilities

• 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, and 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.

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 is considered.
• Experience with RNA, biologics, and cell therapy preferred.
• Experience with 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, and 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.

Pay & Benefits

• Best in class healthcare, plus voluntary benefit programs to support your unique needs.
• A holistic approach to well being with access to fitness, mindfulness, and mental health support.
• Family building benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year end shutdown.
• Savings and investments to help you plan for the future.
• Location specific perks and extras.
• Benefits may vary depending on the nature of your employment and the country where you work.

Moderna is committed to equal opportunity in employment and non discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team.