Principal Scientist, Bioanalytical and Molecular Assay

The Role:

Moderna is seeking an experienced Bioanalytical and Molecular Sciences expert to join the team to perform hands on LC-MS based clinical bioanalysis under GLP/GcLP compliance. A successful incumbent will provide scientific and operational oversight of pharmacokinetic (PK), lipids, protein, and routine biomarker bioanalyses for Moderna mRNA based therapeutic pipeline.

Here’s What You’ll Do:

• Support establishing LC-MS GLP/GCLP regulated capability and facilitate method development, validation, and sample analysis to support clinical and preclinical programs. Responsible for in-house GLP/GCLP infrastructure, hands on troubleshooting, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for bioanalytical activities assuring phase appropriate approach.

• Responsible for the design and execution of phase-appropriate clinical and preclinical analytical strategies including LC-MS based assays, immunoassay, quantitation of lipids and therapeutic proteins, lipid characterization, metabolite identification and PK/PD assay method development.

• 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 9+ years of biotech/pharmaceutical industry experience. A B.S./M.S. with extensive bioanalytical experience will also be considered.

• 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, efficacy 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.

• Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred. Strong knowledge of regulatory guidance such as BMV, M10 and similar.

• Demonstrated deeply understanding of global regulatory requirements including GLP, GCP and the clinical trial process.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes