About this role
About the Role Moderna is expanding its scientific capabilities in the UK and seeking a highly skilled bioanalytical scientist to join the Clinical Bioanalytical team. This role sits at the intersection of basic science research, bioanalysis, and clinical development, supporting phase-appropriate assay development, qualification, and validation to advance mRNA programs. The role focuses on developing robust methodologies within a GCLP-compliant framework to generate high-quality PK/PD data. What You'll Do
- Perform bioanalytical assays utilizing a range of molecular and cellular biology techniques, including gel electrophoresis, droplet digital PCR (ddPCR), quantitative PCR (qPCR), RT-qPCR, and related technologies for the quantitation of RNA in biological matrices.
- Support the integration of basic science research and bioanalytical activities to advance development programs into a GCLP-compliant clinical environment.
- Execute phase-appropriate assay development, qualification, and validation activities supporting pharmacokinetic (PK) and pharmacodynamic (PD) analyses.
- Conduct genomic DNA and RNA isolation and apply molecular biology methodologies to generate high-quality analytical data.
- Ensure assays are developed, optimized, qualified, and validated within required timelines to support program milestones and clinical study needs.
- Establish fit-for-purpose bioanalytical methods that meet scientific, regulatory, and GCLP compliance requirements for clinical use.
- Evaluate and review raw analytical data, assay validation reports, and study reports to ensure data integrity, scientific rigor, and compliance with current regulatory, industry, and Moderna standards.
- Partner with internal and external laboratories to ensure analytical activities are performed according to established quality expectations and regulatory requirements.
- Support analytical equipment procurement, qualification, maintenance, and lifecycle management activities.
- Prepare, maintain, and continuously improve Standard Operating Procedures (SOPs) and supporting documentation.
- Identify, characterize, qualify, and maintain critical reagents required for bioanalytical assay execution.