Associate Director, Stability Lead Development & Clinical

Moderna; Norwood (MA); On-site; USD 142,500 - 256,500; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Generous paid time off

Savings and investment opportunities

Job summary

A biotechnology company in Norwood is hiring a Stability Leader to design and oversee stability strategies for mRNA products. This role requires experience in leading stability strategy and collaborating with cross-functional teams. Candidates should possess a degree in a relevant field and substantial experience in statistical analysis and technical writing. The position includes best-in-class healthcare coverage, generous paid time off, and a competitive salary range of $142,500.00 - $256,500.00.

Qualifications

• 12 years of relevant experience with a Bachelor's degree or 5 years with a PhD.
• Demonstrated ability to balance scientific rigor and regulatory compliance.

Responsibilities

• Define phase-appropriate stability strategies for mRNA products.
• Lead stability data review and statistical evaluation.

Skills

Cross-functional leadership

Statistical analysis

Technical writing

Education

Degree in Life Sciences, Chemistry, Engineering, or related field

Tools

Statistical analysis tools

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.

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

• 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.

The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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!

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 [e-mail].

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.