Lead Scientist, Bioanalytical and Molecular Assays

1 week ago


Norwood, Massachusetts, United States Moderna Theraputics Full time

The Opportunity:

Moderna is in search of a seasoned expert in Bioanalytical and Molecular Sciences to contribute to our team by executing hands-on LC-MS based clinical bioanalysis in compliance with GLP/GcLP standards. The ideal candidate will oversee scientific and operational aspects of pharmacokinetic (PK), lipid, protein, and routine biomarker bioanalyses within Moderna's mRNA therapeutic pipeline.

Key Responsibilities:

  • Facilitate the establishment of LC-MS GLP/GCLP regulated capabilities, including method development, validation, and sample analysis to support both clinical and preclinical initiatives.
  • Manage in-house GLP/GCLP infrastructure, ensuring rigorous laboratory practices and adherence to regulatory requirements for bioanalytical activities.
  • Design and implement phase-appropriate analytical strategies, encompassing LC-MS based assays, immunoassays, lipid quantitation, therapeutic protein analysis, lipid characterization, metabolite identification, and PK/PD assay method development.
  • Review raw data, analytical reports, and assay validation documents to confirm compliance with current regulatory, industry, and Moderna standards, ensuring data quality.
  • Assist in the creation of SOPs, regulatory submissions, and responses to regulatory inquiries as necessary. Proficiency in various LIMS such as Thermo Watson, Lab Vantage, and ELNs is preferred. Familiarity with AI applications in regulated bioanalysis is advantageous.
  • Possess a comprehensive understanding of government guidelines and internal protocols related to clinical trial conduct, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

Qualifications:

Ph.D. in Chemistry, Biochemistry, Cell Biology, Immuno-oncology, Immunology, Cancer Biology, or related disciplines with a minimum of 9+ years of experience in the biotech or pharmaceutical industry. Candidates with a B.S./M.S. and extensive bioanalytical experience will also be considered.

Preferred qualifications include:

  • Experience with RNA, LNP, and cell therapy.
  • A proven track record in analytical development with substantial expertise in bioanalytical LC-MS platforms supporting PK/TK and efficacy in clinical and preclinical toxicology studies.
  • Experience in analytical method development across various platforms, including ELISA, MS, and chromatography, particularly in lipid and therapeutic protein quantitation, metabolite identification, and impurity profiling.
  • Experience managing third-party assay laboratories and collaborations with relevant bioanalytical vendors.
  • Strong knowledge of regulatory guidance such as BMV, M10, and similar.
  • A deep understanding of global regulatory requirements, including GLP, GCP, and the clinical trial process.

Benefits:

Moderna offers a comprehensive suite of benefits, including:

  • Competitive medical, dental, and vision coverage options.
  • Flexible Spending Accounts for medical and dependent care expenses.
  • Lifestyle Spending Account funds for personal enrichment and self-care activities.
  • Family care benefits, including subsidized back-up care options.
  • Access to fitness, nutrition, and mindfulness classes.
  • Generous paid time off, including vacation, sick leave, and holidays.
  • Paid sabbatical after 5 years of service; every 3 years thereafter.
  • 401k match and financial planning tools.

About Moderna:

Founded in 2010, Moderna is dedicated to building a leading mRNA technology platform and a world-class team. We strive to create a culture of belonging and care for our patients, employees, and communities. Recognized as a top biopharma employer, we value innovation and teamwork.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants.



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