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.

Here’s What You’ll 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. 

Here’s What You’ll 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.  That’s why our US benefits and global well-being resources are designed to support you—at 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

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