Scientist, Molecular Assays

The Role:Moderna is seeking a Molecular Assay scientist to join the Bioanalytical and Molecular Assays team. A successful incumbent would help integrate basic science research, bioanalysis, genomics and informatics to move programs into the clinic as well as reverse-engineer clinical findings to novel opportunities for Moderna’s pipeline.Here’s What You’ll Do:Responsible for the effective execution of phase-appropriate biochemical and molecular biology assays to enable pharmacokinetic/pharmacodynamic (PK/PD) analysis, including genomic DNA and RNA isolation, qPCR, ddPCR, RNA sequencing, MSD, ELISA, immunoblotting and other relevant technologies.Responsible to ensure assays are developed in a timely manner to meet program timelines, the qualification or validation of assays is fit for purpose within GcLP compliance for clinical use and troubleshoot any issues that arise internally or with external CRO partners.Review raw data and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Moderna standards and that data are of the required quality (regulatory and scientific).Responsibilities also include analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination, and control of critical reagents for example.Stay abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), internal SOPs and regulations and White Papers, as appropriate, for clinical bioanalysis to ensure practices are consistent with regulatory expectations.Collaborate with clinical operations and sample management to define sample journey and develop appropriate laboratory manuals.Here’s What You’ll Need:A Ph.D. in genetic assays from the following areas: infectious disease, Immuno-oncology, Immunology, Cancer Biology, or related fields and a minimum of 2 years of industry biotech/academic experience.Experience with RNA, biologics and cell therapy preferred.Knowledge of

RT-PCR ,

ddPCR ,

RNA sequencing

and other methodologies for preclinical and clinical assays.Working knowledge of the translational literature in the field.Knowledge of GcLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.A desire to make an impact as part of a high-growth, transformational company that is

Bold, Relentless, Curious, and Collaborative.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit

modernatx.com/careers

to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

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