Associate Director, Stability Lead Development & Clinical

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.

Moderna is strengthening its presence in Norwood Massachusetts a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.

As a stability leader you will define and execute phase-appropriate stability strategies across a diverse mRNA portfolio spanning development clinical and commercial products.
You will operate as a cross-functional subject matter expert translating complex stability data into actionable program regulatory and supply decisions.
This role blends deep scientific expertise statistical insight and matrix leadership to ensure robust shelf-life strategies regulatory success and uninterrupted patient supply.

Heres What Youll Do:

Define and lead phase-appropriate stability strategies aligned to development clinical or commercial program objectives ensuring strong scientific and regulatory positioning across the portfolio.

Design and oversee stability protocols and study plans supporting IND/CTA submissions pivotal readiness registration-enabling packages post-approval commitments and commercial lifecycle initiatives.

Ensure all stability strategies studies and outputs are aligned with ICH guidance global regulatory expectations and internal quality and compliance standards.

Lead stability data review including statistical evaluation and trending analysis to support defensible shelf-life assignments expiry updates storage conditions and risk-based recommendations.

Identify emerging degradation trends product risks and supply vulnerabilities driving proactive cross-functional mitigation strategies.

Provide technical leadership in shelf-life modeling provisional and long-term expiry dating comparability assessments storage condition evaluations and change-impact assessments.

Author and review stability sections for regulatory submissions and responses across clinical registration and post-approval stages.

Partner closely with Analytical Development Quantitative Sciences Process Development Quality Regulatory Clinical Supply Supply Chain and Commercial teams to align stability strategies with program and business needs.

Collaborate with Clinical Supply and Supply Chain to align expiry strategy stability milestones and inventory risk mitigation with evolving program timelines.

Lead and support stability-related OOS/OOT investigations formal risk assessments and issue resolution in partnership with Quality and cross-functional stakeholders.

Contribute to annual product quality reviews shelf-life reassessments lifecycle management and continuous improvement of stability processes tools and governance.

Operate as an influential matrix leader mentoring colleagues and guiding teams through complex technical decisions while fostering clarity alignment and execution.

Leverage digital tools and advanced analytics including opportunities to engage with emerging generative AI capabilities to enhance stability insights data interpretation and decision-making.

Perform additional duties as required to support evolving business and portfolio needs.

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

We act with dynamic range driving strategy and execution at the same time at every step.

We pivot fearlessly in the face of new data.

Heres What Youll Need (Basic Qualifications)

• Education: Degree in Life Sciences Chemistry Engineering Pharmaceutical Sciences or related technical discipline

• Experience: 12 years of relevant experience with Bachelors degree or 5 years of relevant experience with a PhD.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Advanced degree in a relevant field is preferred combined with a 7 years of relevant industry experience

• Significant experience leading stability strategy for biologics vaccines or other complex drug products in either development/clinical or commercial settings.

• Demonstrated experience authoring stability content for major regulatory submissions and supporting health authority interactions.

• Experience operating within cross-functional CMC team structures.

• Experience in statistical analysis stability trending and scientific interpretation of complex data sets to support expiry dating and storage-condition decisions.

• Experience with development and clinical programs or with post-approval/commercial lifecycle management is strongly preferred.

• Demonstrated ability to balance scientific rigor regulatory compliance and business or supply considerations in a fast-paced matrixed environment.

• Experience leading stability-related investigations change assessments and formal risk evaluations with cross-functional partners.

• Strong cross-functional leadership and influence skills with the ability to align stakeholders across Technical Development Quality Regulatory Clinical Supply Supply Chain and Commercial teams as relevant.

• Demonstrated success driving process improvements governance or operating-model enhancements within a CMC or technical development organization.

• Excellent written and verbal communication skills with the ability to distill complex stability topics for technical and non-technical audiences.

• A desire to make an impact as part of a high-growth transformational company that 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 US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage 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 investment opportunities 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 to learn more about our current opportunities.

Our Working Model

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.

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

Equal Opportunities

Moderna is committed to equal employment opportunity 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 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

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 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 .

-