Principal Scientist, Immunogenicity and Ligand Binding Assays

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

This role sits at the forefront of Modernas clinical bioanalytical strategy providing deep scientific expertise and hands-on leadership across immunogenicity and ligand binding assay (LBA) bioanalysis for our mRNA-LNP therapeutic pipeline. As an individual contributor you will shape and execute phase-appropriate bioanalytical strategies that enable critical clinical development decisions while ensuring the highest standards of scientific rigor and regulatory compliance.

Working closely with cross-functional development teams you will drive regulated immunogenicity and bioanalytical activities spanning assay development validation sample analysis data interpretation and regulatory support. You will play a pivotal role in advancing innovative medicines through clinical development while leveraging modern digital capabilities and emerging analytical technologies including opportunities to work alongside advanced data and AI-enabled approaches that accelerate scientific insight generation.

Heres What Youll Do:

• Provide scientific and hands-on oversight of ligand binding assay (LBA)-based bioanalyses supporting Modernas mRNA-LNP therapeutic development programs.
• Support and oversee the Immunogenicity function through clinical science-driven phase-appropriate and risk-based bioanalytical development strategies across advancing stages of clinical development.
• Lead and facilitate anti-drug antibody (ADA) assay and neutralizing antibody assay regulated method development validation and clinical sample testing activities.
• Ensure in-house GcLP compliance across the LBA team systems and procedures maintaining rigorous laboratory practices and regulatory requirements for analytical activities through a phase-appropriate approach.
• Design and execute phase-appropriate clinical analytical strategies supporting development programs.
• Drive development validation and implementation of:
  • Cell-based assays
  • Immunoassays
  • Quantitation of translated proteins
  • Pharmacokinetic (PK) assays
  • Pharmacodynamic (PD) assays
• Review and evaluate raw analytical data assay validation data and study reports to ensure scientific integrity data quality and compliance with current regulatory industry and Moderna standards.
• Assess analytical performance and laboratory compliance to ensure data generated meet both scientific and regulatory expectations.
• Collaborate with internal and external stakeholders to support clinical bioanalytical activities throughout the product development lifecycle.
• Contribute to regulatory submissions and support responses to regulatory authority questions and information requests.
• Maintain current knowledge of emerging scientific literature industry best practices regulatory expectations and evolving guidance related to clinical bioanalysis.
• Ensure adherence to Good Clinical Laboratory Practice (GcLP) Good Laboratory Practice (GLP) Good Clinical Practice (GCP) internal SOPs applicable regulations guidance documents and relevant white papers.
• Apply scientific judgment and risk-based decision making to support robust bioanalytical strategies that accelerate development while maintaining quality and compliance.
• Partner with multidisciplinary teams to advance innovative analytical approaches and continuously improve laboratory and bioanalytical processes.

The key Moderna Mindsets youll need to succeed in the role:

• We obsess over learning. We dont have to be the smartest we have to learn the fastest.
• We act with dynamic range driving strategy and execution at the same time at every step.

Heres What Youll Need (Basic Qualifications)

• A Ph.D. in infectious disease Immuno-oncology Immunology Cancer Biology or related fields and a minimum of 10 years of industry biotech/pharmaceutical experience. M.S. with extensive bioanalytical experience are considered
• Experience with RNA biologics and cell therapy preferred
• Experience of various platforms such as ECL Gyrolabs reporter gene assays DelPhia assays and other methodologies for clinical assays.
• Ability to effectively communicate scientific concepts program objectives data analysis within a matrix environment.
• Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science.
• Experience on Watson LIMS and LabVnatage eLBN would be an advantage.
• A desire to make an impact as part of a high-growth transformational companythat is Bold Relentless Curious and Collaborative.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being with access to fitness mindfulness and mental health support

• Family building benefits including fertility adoption and surrogacy support

• Generous paid time off including vacation bank holidays volunteer days sabbatical global recharge days and a discretionary year-end shutdown

• Savingsandinvestments to help you plan for the future

• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010 we have aspired to build the leading mRNA technology platform theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.

As we build our company we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

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

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at .

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Required Experience:

Staff IC

Employment Type : Full-Time
Experience: years
Vacancy: 1