Scientist, Genetic Assays

Moderna

Oxford, United Kingdom

The Role:

We are seeking an experienced Genetic Assay Scientist to join our Clinical Bioanalytical team. The successful candidate will integrate basic science research, bioanalysis, genomics, and informatics to advance programs into the clinic and leverage clinical findings to identify novel opportunities for Moderna’s pipeline.

Here’s What You’ll Do:

Your key responsibilities will be:

Design and execute phase-appropriate biochemical and molecular biology assays for pharmacokinetic/pharmacodynamic (PK/PD) analysis, including genomic DNA and RNA isolation, qPCR, ddPCR, RNA sequencing, MSD, ELISA, immunoblotting, and other relevant technologies;
Ensure timely development of assays to meet program timelines, and ensure qualification or validation of assays is fit for purpose within GcLP compliance for clinical use, troubleshooting issues that arise internally or with external CRO partners;
Evaluate and review raw data, study analytical reports, and assay validation reports to ensure laboratories perform analysis in compliance with current regulatory, industry, and Moderna standards, ensuring high-quality data (regulatory and scientific).

Your responsibilities will also include:

Establish internal and external mRNA-based bioanalytical capabilities and facilitate method development to support Moderna’s portfolio;
Oversee analytical equipment procurement/qualifications, preparation and maintenance of SOPs, and control of critical reagents;
Stay updated on literature, government guidelines, internal guidance on clinical trial conduct, including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs, and regulations for clinical bioanalysis to ensure practices align with regulatory expectations;
Collaborate with clinical operations and sample management to define the sample journey and develop appropriate laboratory manuals.

The key Moderna Mindsets you’ll need to succeed in the role:

Prioritize the platform: Focus on the broader goals and vision of Moderna’s mRNA technology, ensuring your contributions support our overarching mission of innovative healthcare solutions;
Obsess over learning: Continuously seek new knowledge and methodologies to stay ahead in the field of genetic assays, driving the advancement of clinical bioanalysis through rapid and effective learning;
Act with urgency: Maintain a proactive and responsive approach to project timelines and deliverables, ensuring timely execution and adaptation to new data and findings.

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;
This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

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