Overview
In this role you contribute to the development, validation, and execution of bioanalytical assays to support pharmacodynamic and immunogenicity endpoints for novel mRNA-derived proteins. You will operate in a fast-paced laboratory, ensure regulatory compliance, and deliver high-quality data for clinical programs. You’ll work with cross-functional partners and leverage evolving digital tools to optimize scientific workflows. The opportunity centers on advancing de novo assays for innovative mRNA medicines within Moderna’s mission-driven environment.
Pay / Benefits
- competitive healthcare
- well-being resources (fitness, mindfulness, mental health)
- family building benefits
- generous paid time off
- discretionary year-end shutdown
- savings and investments
Responsibilities
- Support development, optimization, and validation of ligand-binding and cell-based assays for pharmacodynamic and immunogenicity endpoints
- Perform clinical sample testing across biological matrices under GcLP and using Thermo Watson LIMS
- Deliver assay development and validation activities on schedule aligned with key program milestones
- Maintain accurate documentation in electronic lab notebooks
- Support generation, characterization, and control of critical reagents
- Contribute to laboratory operations to ensure efficiency and regulatory compliance
- Prepare SOPs, technical reports, and data presentations
- Review data and reports to ensure regulatory compliance and data quality
- Support procurement, qualification, and implementation of analytical equipment
- Collaborate with Clinical Operations and Sample Management on end-to-end clinical sample journey
- Develop lab manuals supporting clinical sample management and testing
- Contribute to a collaborative, high-performance team developing de novo bioanalytical assays for novel mRNA-derived proteins
Key requirements
- BA/BS in biological science with minimum 5 years of industry Biotech/pharmaceutical/CRO experience; MS with 3+ years of experience
- Experience with Ligand Binding and/or Cell Based Assays required
- Preferred: PK, ADA, or nAb assay experience
- Preferred: regulated environment (GLP, GcLP, GMP) experience
- Strong attention to detail, multitasking, and collaboration skills
- Effective communication of objectives, data analysis, and findings to teams
- Knowledge of GcLP requirements and current regulatory trends in analytical science
- Experience with Watson LIMS and LabVantage eLBN is a plus
- Desire to contribute in a high-growth, transformational company with Moderna values
- attention to detail
- effective communication
- team collaboration
- Ligand Binding assays
- Cell-based assays
- GcLP/GLP/GMP awareness
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