Overview
In this role you will lead and hands-on oversee LBA-based bioanalysis for Moderna’s mRNA-LNP programs, enabling critical clinical decisions with rigorous science and regulatory compliance. You will drive immunogenicity and ADA/neutralizing antibody assay development, validation, and clinical testing, while ensuring GcLP/GxP standards. Collaborating with cross-functional teams, you’ll implement phase-appropriate analytical strategies and leverage emerging analytics to accelerate development. This position offers impact across development stages, with opportunities to shape innovative analytics and data-enabled insights within a high-growth, mission-driven environment. You will work in a team-
Pay / Benefits
- best-in-class healthcare
- fertility, adoption, and surrogacy support
- generous paid time off
- discretionary year-end shutdown
- global recharge days
- retirement/investment options
Responsibilities
- Provide oversight of LBA-based bioanalyses across immunogenicity programs
- Lead ADA and neutralizing antibody assay development and validation for regulatory use
- Ensure in-house GcLP compliance for LBA activities
- Design and execute phase-appropriate clinical analytical strategies
- Drive development and validation of cell-based assays, immunoassays, PK/PD assays, and protein quantification
- Review analytical data, validation data, and study reports for integrity and regulatory alignment
- Collaborate with internal and external stakeholders across the product development lifecycle
- Support regulatory submissions and responses to authority inquiries
- Maintain knowledge of regulatory expectations and evolving guidance in clinical bioanalysis
- Apply risk-based scientific judgment to accelerate development while upholding quality
- Partner with multidisciplinary teams to improve analytical approaches and laboratory processes
- Maintain compliance with GLP/GCP, SOPs, and relevant regulations
Key requirements
- Ph.D. in relevant fields with 10+ years of industry biotech/pharmaceutical experience (M.S. with extensive experience also considered)
- Experience with RNA, biologics, and cell therapy preferred
- Proficiency with platforms such as ECL, Gyrolabs, reporter gene assays, and DelPhia assays
- Strong ability to communicate scientific concepts in a matrix environment
- Knowledge of GLP, GCP, and current regulatory expectations for bioanalytical science
- Experience with Watson LIMS and LabVantage eLBN advantageous
- Interest in contributing to a high-growth, transformational company with bold, curious, collaborative culture
- Effective scientific communication
- Cross-functional collaboration
- Regulatory-minded decision making
- LBA immunogenicity bioanalysis
- ADA and neutralizing antibody assay development and validation
- Clinical sample analysis and data interpretation
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