Scientist, Genetic Assays

Scientist, Genetic Assays

Moderna

Oxford, United Kingdom

The Role:

As a sole-contributor scientist, you will bring deep expertise in genetic, biochemical and molecular biology assays to develop and execute phase-appropriate approaches supporting pharmacokinetic/pharmacodynamic (PK/PD) analysis. You will work across technologies including genomic DNA and RNA isolation, qPCR, ddPCR, RNA sequencing, MSD, ELISA and immunoblotting, while establishing robust mRNA-based bioanalytical capabilities internally and with external partners.

This is an opportunity to operate at the intersection of translational science, clinical bioanalysis and emerging technology. Alongside hands-on scientific and regulatory responsibilities, you will have opportunities to get close to Generative AI and digital tools that can support scientific workflows, knowledge synthesis and data-driven ways of working across Moderna.

Here's What You'll Do:

• Design and effectively execute phase-appropriate biochemical and molecular biology assays to enable PK/PD analysis, including genomic DNA and RNA isolation, qPCR, ddPCR, RNA sequencing, MSD, ELISA, immunoblotting and other relevant technologies.
• Develop assays in a timely manner aligned with program timelines, ensuring assay qualification or validation is fit for purpose within GcLP compliance for clinical use.
• Troubleshoot scientific and technical issues arising internally and through external CRO partners, applying rigorous molecular and bioanalytical expertise to maintain assay performance and data quality.
• Evaluate and review raw data, study analytical reports and assay validation reports, as appropriate, ensuring laboratories perform analyses in compliance with current regulatory, industry and Moderna standards and that resulting data meet required regulatory and scientific quality expectations.
• Establish internal and external mRNA-based bioanalytical capability and facilitate method development to support Moderna’s portfolio.
• Support analytical equipment procurement and qualification, preparation and maintenance of SOPs, and the determination and control of critical reagents.
• Stay current with scientific literature, government guidelines and internal guidance relating to clinical trial conduct, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs, applicable regulations and White Papers for clinical bioanalysis, ensuring practices remain consistent with regulatory expectations.
• Collaborate with Clinical Operations and Sample Management to define the sample journey and develop appropriate laboratory manuals.
• Apply expert knowledge of RT-PCR, ddPCR, RNA sequencing and other methodologies used for preclinical and clinical assays.
• Bring working knowledge of the translational literature and competitive landscape in the ASO field, connecting external scientific developments with Moderna’s bioanalytical work.
• Communicate complex scientific concepts, program objectives and data analyses effectively within a matrix environment.
• Apply knowledge of GcLP requirements alongside an understanding of current industry trends and regulatory expectations associated with analytical science.
• Leverage experience with RNA, biologics and cell therapy where applicable to strengthen assay strategies and bioanalytical approaches.
• Utilize Lab Information Management Systems (LIMS), electronic laboratory notebooks (eLNB) and laboratory automation where relevant; experience in these areas would be an advantage.
• Explore opportunities to work alongside digital and Generative AI-enabled tools as Moderna continues to evolve how scientific information, workflows and insights can be used to accelerate impact.

Here’s What You’ll Bring to the Table:

• A Ph.D. in genetic assays from the following areas: infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 5 years of industry biotech/pharmaceutical experience. B.S./M.S. with a minimum of 7 years of bioanalytical and GcLP/GLP experience are considered.
• Experience with RNA, biologics and cell therapy preferred.
• Expert knowledge of RT-PCR, ddPCR, RNA sequencing and other methodologies for preclinical and clinical assays.
• Working knowledge of the translational literature and competitive landscape in the ASO field.
• Ability to effectively communicate scientific concepts, program objectives, data analysis within a matrix environment.
• Knowledge of GcLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.
• Experience on Lab Information Management Systems (LIMS) and electronic lab note books (eLNB) would be a plus.
• Experience on automation would be a plus.