Senior Specialist, Bioanalytics

The Role:

ModernaTX, Inc. seeks a Senior Specialist, Bioanalytics for its Cambridge, Massachusetts location.

Here’s What You’ll Do:

• Utilizing laboratory skills, analyze data generated by external vendors, such as Contract Research Organizations, (CROs), from ligand binding assays such as Enzyme linked Immunosorbent Assays (ELISA) and Meso Scale Discovery (MSD) for quantifying protein analytes in relevant nonclinical species, matrices, and make recommendations and troubleshoot to support Investigational New Drug (IND) filings.

• Engage with CROs and manage method transfer, method validation, bioanalysis, and troubleshooting of nonclinical bioanalytical methods such as Pharmacokinetics (PK) and Ligand Binding Assay (LBA).

• Responsible for hands on development of quantitative bioanalytical methods, including ELISA, MSD, branched DNA (bDNA), and quantitative Polymerase Chain Reaction (qPCR), and immunogenicity assays as needed, and explore new technologies to enhance sensitivity and dynamic range, among other parameters.

• Work with Therapeutic Areas, non-clinical teams and program/project management functions to drive non-clinical development of therapeutic candidates.

• Review and approve study designs, requirements, and overall workflows, generating and reviewing Standard of Work (SoW), assisting with Purchase Orders (PO), and any follow-up, in order to enable study conduct.

• Collaborate and provide input cross-functionally on knowledge gained from prior experience on best practices for laboratory techniques, method development, and Qualification to external CROs.

• Remain up to date and proficient with current and changing scientific regulations and support regulated bioanalysis at CROs.

• Maintain responsibility for multiple assay-related aspects for platform and development programs.

• Provide summary presentations and detailed reports to internal and external stakeholders.

Here’s What You’ll Bring to the Table:

Minimum requirements:

• Requires a Master’s degree in Biotechnology, Microbiology, or related field and three (3) years of experience in the offered position or as a Research Associate or related position.

• 3 years of experience must include:

  • Bioanalytical Assays, including Ligand Binding Assays and hybridization-based quantitative bioanalytical methods to measure analytes in biological samples;

  • Bioanalytical Method Qualification, Method transfer, and Method Validation;

  • Bioanalytical method development for evaluating PK/Toxicokinetic, safety, and efficacy endpoints for nonclinical and platform programs;

  • Performing sample analysis, troubleshooting and bioanalytical reports for assay validation;

  • Quantifying protein analytes in non-clinical species and matrices; and

  • Troubleshooting and refining assay conditions to improve accuracy and reliability using knowledge of immunology and pharmacology.

Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R17694) or email resume and cover letter to careers@modernatx.com with subject line: R17694.

#DNI

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

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