Overview
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
- Effective scientific communication
- Collaborative mindset
- Problem-solving under regulatory constraints
- RT-PCR
- ddPCR
- RNA sequencing
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