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Associate Director, Bioanalytical Sciences

Moderna, Inc.
Cambridge, MA
Start date
Mar 31, 2023

Job Details

The Role:

Moderna is seeking an experienced Bioanalytical and Molecular Sciences expert to join the Clinical team to lead LC-MS based 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.

Heres What Youll Do:

  • Support establishing LC-MSGLP/GCLP regulated capability and facilitate method development and validation to support clinical and preclinical programs. Responsible for in-house GLP/GCLP infrastructure, systems and procedures to ensure adequate rigorous laboratory practices & regulatory requirements for analytical activities ensuring 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 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.

  • 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.

Heres What Youll Bring to the Table:

  • Ph.D. in chemistry, biology, biochemistry or related field and 10+ years of experience

  • Experience with RNA, LNP and cell therapy preferred

  • Track record with analytical development with deepexpertisewith bioanalyticalLC-MSplatform 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.) includingquantitation of therapeutic proteins in biological matrices, metabolite identification and impurity profiling.

  • Experience managing third party assay laboratories, collaborations, and relevant bioanalytical vendors preferred.

  • 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
  • Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit

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

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.




Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.


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