About this role
About the Role Joining Moderna means advancing mRNA science to transform medicine. This role is an opportunity to join Moderna's Bioanalytical and Molecular Assays – Ligand Binding Assays team as an individual contributor, helping to advance the development of innovative mRNA medicines. You will develop, validate, and execute bioanalytical assays that generate critical pharmacodynamic and immunogenicity data supporting clinical programs. What You'll Do
- Support the development, optimization, and validation of ligand-binding and cell-based assays to evaluate pharmacodynamic and immunogenicity endpoints for novel mRNA-derived proteins.
- Perform clinical sample testing across a range of biological matrices in compliance with Good Clinical Laboratory Practice (GcLP) requirements using Thermo Watson LIMS.
- Deliver assay development and validation activities on schedule to support key program milestones.
- Maintain accurate experimental documentation using electronic laboratory notebooks.
- Support the generation, characterization, establishment, and control of critical reagents.
- Contribute to laboratory operations to ensure an efficient and compliant working environment.
- Prepare Standard Operating Procedures (SOPs), technical reports, and scientific data presentations.
- Review raw experimental data, analytical study reports, and assay validation reports to ensure laboratory activities comply with current regulatory requirements, industry standards, and Moderna quality expectations.
- Confirm that generated data meet both scientific and regulatory expectations.
- Support the procurement, qualification, and implementation of analytical equipment.
- Partner closely with Clinical Operations and Sample Management to define the end-to-end clinical sample journey.
- Develop fit-for-purpose laboratory manuals that support successful clinical sample management and testing.
- Contribute to a collaborative, high-performance team focused on developing de novo bioanalytical assays for novel mRNA-derived proteins. What We're Looking For
- Strong scientific expertise with operational excellence and a track record of developing, optimizing, and validating bioanalytical assays.
- Experience with ligand-binding and cell-based assays, preferably for pharmacodynamic and immunogenicity endpoints.
- Familiarity with Good Clinical Laboratory Practice (GcLP/GLP/GCP), regulatory expectations, and Moderna quality standards.
- Proficiency with electronic laboratory notebooks and ability to prepare SOPs, technical reports, and data presentations.
- Experience with Thermo Watson LIMS and the procurement, qualification, and implementation of analytical equipment.
- Ability to work in a fast-paced, high-performing laboratory and partner across Clinical Operations, Sample Management, and other functions.
- Aptitude for leveraging digital tools and evolving AI-enabled workflows to enhance scientific decision-making. Nice to Have
- Experience with de novo bioanalytical assay development for novel mRNA-derived proteins.
- Additional experience with other analytical platforms and data management systems.
- Ability to operate in a collaborative, cross-functional environment and support end-to-end clinical sample management. Compensation & Benefits
- Salary: Not disclosed
- Benefits: Not disclosed