In this role you will design and execute phase-appropriate biochemical and molecular assays to enable PK/PD analyses, integrating genetic, bioanalytical, and translational work to support Moderna’s clinical programs. You will build and validate mRNA-based bioanalytical capabilities, collaborating with cross-functional teams and CRO partners while embracing digital tools to streamline workflows. You will work onsite at Oxford and contribute to a fast-moving pipeline at the intersection of translational science and bioanalysis, shaping assay strategies for clinical development.
Pay / Benefits
competitive healthcare
well-being resources
family building benefits
paid time off
sabbatical and global recharge days
discretionary year-end shutdown
Responsibilities
Design and perform phase-appropriate biochemical and molecular assays (DNA/RNA isolation, qPCR, ddPCR, RNA sequencing, MSD, ELISA, immunoblotting) for PK/PD analysis
Develop assays aligned with program timelines and ensure qualification/validation within GcLP for clinical use
Troubleshoot technical issues with internal teams and CRO partners to maintain data quality
Review raw data and validation reports to ensure regulatory and scientific quality standards are met
Establish internal and external mRNA-based bioanalytical capability and support method development for Moderna’s portfolio
Support procurement and qualification of analytical equipment and maintain SOPs and reagents control
Stay current with GLP/GCP guidelines and internal SOPs relevant to clinical bioanalysis
Collaborate with Clinical Operations and Sample Management to define sample workflows and laboratory manuals
Apply RT-PCR, ddPCR, RNA sequencing and related methods in preclinical/clinical assays
Balance external scientific developments with Moderna’s bioanalytical work in the ASO field
Communicate complex concepts effectively within a matrix environment
Leverage LIMS, eLNB and laboratory automation where relevant
Explore use of Generative AI-enabled tools to enhance scientific workflows and data handling
Key requirements
Ph.D. in genetic assays or related fields with 5+ years industry biotech/pharma experience OR B.S./M.S. with 7+ years bioanalytical and GcLP/GLP experience
Expert knowledge of RT-PCR, ddPCR, RNA sequencing and related assay methods
Working knowledge of translational literature and ASO landscape
Understanding of GcLP requirements and current regulatory trends in analytical science
Experience with LIMS and eLNB is a plus; automation experience a plus
Strong communication skills and ability to work in a matrix environment
Knowledge of GLP and GCP guidance and clinical trial conduct
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