Sr. Scientist, Bioanalytical and Molecular Assay Team

The Role:

Moderna is seeking an experienced Senior Scientist to join our Bioanalytical and Molecular Assays Team. This role involves supporting regulated bioanalysis for clinical and non-clinical studies, biomarker analysis, and biotransformation using mass spectrometry. The successful candidate will be responsible for hands-on experimentation, as well as providing scientific and operational oversight of bioanalysis for pharmacokinetics (PK), biomarkers (proteins and metabolites), and lipids within Moderna's mRNA-based therapeutic pipeline.

Heres What Youll Do:

Conduct method development, validation and sample analysis for quantitative bioanalysis of protein and metabolite biomarkers using LC-MS and high resolution mass spectrometry. Develop in house metabolomics capability and support translational and clinical studies.
Conduct biotransformation experiments, including but not limited to metabolite identification, mass balance, protein binding, and ADME investigations, for Moderna's mRNA-based therapeutic pipeline.
Support the establishment of LC-MS GLP/GCLP regulated bioanalysis capability and facilitate method development, validation, and sample analysis to support clinical and preclinical programs. Responsible for in-house GLP/GCLP bioanalytical method development using mass spectrometry, including hands-on troubleshooting, and developing systems and procedures to ensure rigorous laboratory practices and compliance with regulatory requirements for bioanalytical activities, ensuring a phase-appropriate approach.
Responsible for designing and executing phase-appropriate clinical and preclinical analytical strategies for LC-MS-based assays, including the quantitation of lipids, biomarker proteins, and metabolites, lipid characterization and metabolite identification.
Evaluate and review raw data and study analytical reports 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).
Assist in writing SOPs, regulatory submissions and in responding to regulatory queries when needed. Hands on experience in using various LIMS such as Thermo Watson, Lab Vantage ELNs etc. Knowledge of AI application in regulated bioanalysis is preferred.
Deep knowledge of 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.

Heres What Youll Bring to the Table:

Ph.D. in Chemistry, Biochemistry, Cell Biology, Immuno-oncology, Immunology, Cancer Biology, or related fields with a minimum of 5+ years of biotech/pharmaceutical industry experience. A B.S./M.S. with extensive bioanalytical experience will also be considered.
Extensive experience in regulated bioanalytical practices with LC-MS and high resolution mass spectrometry within the industry.
In-depth knowledge of proteomics or metabolomics is a plus.
Strong biotransformation experience. Familiar with HRMS and metabolite ID. Knowledge in ADME of therapeutic is a plus
Experience with RNA, LNP and cell therapy preferred
Track record with analytical development with deep expertise with bioanalytical LC-MS platform to support PK/TK in clinical and preclinical toxicology studies
Experience with analytical method development across various platforms, (e.g. ELISA, MS, chromatography, etc.) including quantitation of lipids and therapeutic proteins in biological matrices, metabolite identification and impurity profiling.
Possess strong knowledge of regulatory guidance, such as BMV, M10, and similar standards.
Demonstrated deep understanding of global regulatory requirements, including GLP, GCP, and the clinical trial process.

At Moderna, we believe that when you feel your best, you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since 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.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

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.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

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.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

Were focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at ... .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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