Associate Director, Stability Lead Development & Clinical
Moderna
This listing was originally posted on Moderna's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
Upgrade to Pro to access the AI-generated 'Read before applying' briefing and other premium pharma intelligence.
Upgrade to Pro — $25/moThe 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.
Here’s What You’ll 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 you’ll 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.”
Here’s What You’ll Need (Basic Qualifications)
Education: Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline
Experience: 12 years of relevant experience with Bachelor’s degree or 5 years of relevant experience with a PhD.
Here’s What You’ll 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. 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 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 modernatx.com/careers 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 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.
Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-TR2-
Explore related positions you might be interested in
We'll notify you when matching roles are posted.
Interviewed at Moderna?
Help others prepare — share your experience anonymously.
BIOTECHNOLOGY
RNA Therapies
Upgrade to Pro to access AI interview prep brief and other premium pharma intelligence.
Upgrade to Pro — $25/mo