Bioanalytical Scientist – Clinical Bioanalytical Team

The Role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

As Moderna expands its scientific capabilities in the UK, we are seeking a highly skilled bioanalytical scientist to join our Clinical Bioanalytical team. This role sits at the intersection of basic science research, bioanalysis, and clinical development, helping advance innovative mRNA programs through phase-appropriate assay development, qualification, and validation activities.

Working in a highly collaborative environment, you will play a critical role in ensuring robust bioanalytical methodologies are developed and transferred into a GCLP-compliant framework to support clinical programs.

This is an opportunity to contribute directly to the generation of high-quality pharmacokinetic and pharmacodynamic data while working with advanced molecular biology technologies and emerging digital capabilities that are transforming drug development.

Here’s 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
  • Related technologies for RNA quantitation in biological matrices.
• Support the integration of basic science research and bioanalytical activities to advance 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
  • Compliance with current regulatory, industry, and Moderna standards.
• Partner with internal and external laboratories to ensure analytical activities align with quality expectations and regulatory requirements.
• Support:
  • Analytical equipment procurement, qualification, maintenance, and lifecycle management.
  • Preparation, maintenance, and continuous improvement of Standard Operating Procedures (SOPs) and supporting documentation.
• Identify, characterize, qualify, and maintain critical reagents required for bioanalytical assay execution and long-term program support.
• Collaborate closely with Clinical Operations, Sample Management, and cross-functional development teams to:
  • Define sample journeys.
  • Develop laboratory manuals supporting clinical trial execution.
• Maintain detailed and accurate electronic laboratory notebooks and ensure documentation practices are consistently followed.
• Contribute to continuous improvement initiatives enhancing:
  • Laboratory efficiency
  • Data quality
  • Compliance
  • Operational excellence.
• Leverage:
  • Evolving digital tools
  • Automation technologies
  • Generative AI-enabled scientific workflows to improve analytical processes and data interpretation.
• Operate effectively within a dynamic, fast-paced environment, demonstrating:
  • Flexibility
  • Scientific curiosity
  • Commitment to team success.