Director, CMC Stability (Norwood)

The RoleCMC is seeking a dynamic and experienced Director, CMC Stability to lead an end-to-end stability function spanning non-clinical-enabling, clinical, and commercial programs. This leader will translate target product profile (TPP) expectations into scientifically robust stability and shelf-life strategies, design stability studies that demonstrate those claims, and ensure stability data are generated, interpreted, and communicated in ways that enable timely CMC decisions, regulatory filings, and product lifecycle management. This is an onsite role based in Moderna’s Technology Center campus in Norwood, MA.In this role, you will lead a high-performing stability team responsible for portfolio stability strategy, study design, capacity planning, data trending and expiry assessment, stability reviews, stability forecasting, submission authoring, and responses to health authority questions. You will be accountable for ensuring stability strategy is integrated into product team milestones and that program teams have clear, decision-grade stability updates at the moments that matter.To be successful, you will bring strong CMC judgment, deep stability science, and the ability to make practical trade-off decisions in a fast-paced, matrixed environment. You will help teams evaluate deviations, excursions, out-of-trend signals, capacity constraints, shelf-life optionality, and prioritization decisions with clear understanding of compliance, supply, patient, and regulatory implications. You are an execution-oriented leader who can establish effective operating models, develop talent, and influence across Analytical Development, Quality, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and product teams.Here’s What You’ll DoLead the end-to-end CMC Stability function across non-clinical-enabling, clinical, and commercial programs, ensuring stability strategies are aligned with product goals, CMC strategy, regulatory expectations, and supply needs.Translate target product profile (TPP) expectations into required stability and shelf-life claims, including storage condition, in-use, shipping, handling, excursion, and lifecycle flexibility needs.Define and oversee scientifically robust stability study designs that demonstrate claims are met and support clinical advancement, regulatory approvals, commercial launch, and post-approval lifecycle management.Build and maintain effective stability operating models, governance, and decision forums that clarify product team accountability, critical milestones, stability deliverables, and escalation pathways.Drive effective utilization of stability capacity to enable shelf-life flexibility, regulatory optionality, lifecycle commitments, comparability assessments, and strategic portfolio prioritization.In partnership with Quantitative Sciences, oversee stability data trending, statistical analysis, expiry assessments, and stability reviews to identify emerging risks, inform shelf-life decisions, and enable clear cross-functional action plans.Provide technical leadership for out-of-trend investigations, atypical stability observations, temperature excursions, shipping excursions, deviations, comparability questions, and product risk assessments.Make and influence risk-based decisions on prioritization and trade-offs across stability studies, sample pulls, testing capacity, data package timing, regulatory commitments, and supply continuity.Partner with Quantitative Sciences, Analytical Development, Quality Control, Quality Assurance, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and program teams to ensure stability plans are executable and integrated with broader CMC control strategies.Oversee authoring and review of stability sections for regulatory submissions, briefing packages, annual reports, post-approval supplements, and responses to health authority questions, including relevant RTQs.Establish portfolio-level stability forecasting, dashboards, and metrics, including study start readiness, pull/test cadence, turnaround time, backlog, protocol/report cycle time, and regulatory commitment tracking.Develop, mentor, and lead a high-performing team of stability leads and associates, fostering a culture of scientific rigor, accountability, compliance, collaboration, and continuous improvement.Here’s What You’ll Need (Basic Qualifications)Education: Degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related technical disciplineExperience: 15 years of relevant experience with Bachelor’s degree or 10 years of relevant experience with a PhDHere’s What You’ll Bring to the Table (Preferred Qualifications)PhD in a relevant scientific or engineering discipline is preferred.Deep expertise in stability strategy and execution across development, registration, commercial launch, and lifecycle management for biologics, vaccines, mRNA/nucleic acid-based therapeutics, drug products, or other complex modalities.Strong knowledge of global stability expectations and guidance, including ICH Q1A–Q1E, accelerated and long-term stability design, statistical shelf-life assessment, bracketing/matrixing concepts, and post-approval stability commitments.Demonstrated ability to translate product, patient, supply, and regulatory needs into executable stability strategies, shelf-life claims, storage conditions, and risk-based evidence packages.Experience authoring or contributing to IND/CTA/BLA/MAA stability sections, health authority responses, RTQs, annual reports, post-approval supplements, and regulatory commitment management.Strong technical judgment in stability data interpretation, trend analysis, expiry assignment, out-of-trend investigations, temperature excursions, deviations, comparability assessments, and product risk management.Experience developing and operationalizing stability workflows, governance models, dashboards, capacity forecasts, and metrics that improve transparency, prioritization, cycle time, quality, and decision-making.Proven track record leading cross-functional teams and influencing stakeholders across Analytical Development, QC, QA, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and product teams.Strong people leadership experience, including hiring, developing, coaching, and performance management of technical staff in a matrixed environment.Excellent communication, executive presence, and stakeholder management skills, with the ability to communicate complex stability risks and trade-offs clearly to technical and non-technical audiences.Ability to operate strategically while driving detailed execution in a fast-paced environment, with a commitment to scientific rigor, compliance, continuous improvement, and Moderna’s values of Bold, Relentless, Curious, and Collaborative.Pay & BenefitsAt 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 needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investments to help you plan for the futureLocation-specific perks and extrasThe salary range for this role is $167,000.00 - $300,700.00. 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.About ModernaSince 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 OpportunitiesModerna 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]]> <