Job Description
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 Moderna’s 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.
Here’s What You’ll Do:
Provide scientific and hands-on oversight of ligand binding assay (LBA)-based bioanalyses supporting Moderna’s 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 you’ll need to succeed in the role:
We obsess over learning. We don’t 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.
Here’s What You’ll 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. That’s why our global benefits and well-being resources are designed to support you—at 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
Savings and investments 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, 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 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 modernatx.com/careers 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 person's 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.
We’re 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 leavesandaccommodations@modernatx.com.
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