The Role

Moderna is seeking a Principal Research Associate to serve as a critical bridge for development, method transfer, and routine operations between Analytical Development (AD) and cross-functional partners including Analytical Sciences & Technology (AST), Quality Control (QC), Analytical Technical Operations (ATO), and Quality Assurance (QA). This individual will play a key role in ensuring robust method development for clinical-stage qualification and commercial validation-readiness.

The ideal candidate brings deep technical expertise in analytical methods, such as HPLC and molecular biology assays, and with a strong focus on method readiness, transfer, and phase appropriate qualification and validation. Key responsibilities include proactively mitigating risks related to method development and validation per ICH Q2 and Q14, troubleshooting out-of-expectation results, and articulating continuous improvement opportunities related to method transfer and routine operations. This role requires strong collaboration, ownership, and the ability to operate effectively at the interface of development and operations.

Here’s What You’ll Do

• Serve as a liaison between Method Development, AST, ATO, and QC, ensuring alignment on analytical method expectations, readiness, and performance

• Represent Analytical Development in cross-functional forums with AS&T and QC·

• Ensure methods are designed to meet appropriate technical, operational, and regulatory requirements before qualification or validation·

• Serve as subject matter expert for investigations and performance issues across development and QC environments, identifying root causes, supporting hypothesis tests, and implementing solutions·

• Influence method development, assay optimization and continuous improvement efforts based on operational feedback, robustness requirements, and lifecycle needs·

• Collaborate with Quality and AST teams to support deviation investigations, CAPAs, and change controls related to analytical methods·

• Analyze and interpret complex datasets to inform performance, variability, and comparability·

• Author and review technical documentation including protocols, reports, method lifecycle documents

Here’s What You’ll Bring to the Table

• MS with 5 years or BS with 8 years of biotech or pharmaceutical industry experience in analytical development.

• Strong hands-on experience with analytical methods, such as HPLC, Absorption, and Molecular Biology assays·

• Demonstrated experience with analytical method transfer to QC or external laboratories·

• Proven ability to troubleshoot complex assay issues and lead investigations in a GMP or late-stage development environment·

• Understanding of CQA frameworks, assay lifecycle management, and regulatory expectations·

• Experience working cross-functionally with Quality, QC, and/or manufacturing organizations·

• Strong analytical thinking and ability to interpret data to drive decisions and improvements·

• Excellent communication skills with the ability to translate technical concepts across functions·

• Ability to manage multiple priorities in a fast-paced, highly collaborative environmentSelf-motivated, proactive, and comfortable operating with a high degree of ownership

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

• At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive 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 planning benefits, including fertility, adoption, and surrogacy support

• Generous paid time off, including vacation, 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

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.

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.

Equal Opportunities

Moderna is committed to equal employment opportunity 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.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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

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 accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at leavesandaccommodations@modernatx.com. 

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