Director, CMC Stability

CMC 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.

Responsibilities

Lead the end-to-end CMC Stability function across non-clinical-enabling, clinical, and commercial programs; Translate target product profile (TPP) expectations into stability and shelf-life claims; Define and oversee scientifically robust stability study designs; Build and maintain effective stability operating models, governance, and decision forums; Drive effective utilization of stability capacity; Oversee stability data trending, statistical analysis, expiry assessments, and stability reviews; 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; Partner with Quantitative Sciences, Analytical Development, Quality Control, Quality Assurance, Regulatory CMC, Manufacturing, MS&T, Clinical Supply, Commercial Supply, and program teams; Oversee authoring and review of stability sections for regulatory submissions and health authority responses; Establish portfolio-level stability forecasting, dashboards, and metrics; Develop, mentor, and lead a high-performing team of stability leads and associates

Requirements

Degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related technical discipline; 15 years of relevant experience with Bachelor’s degree or 10 years of relevant experience with PhD; U.S. person status required due to export control laws

Nice to have

PhD in a relevant scientific or engineering discipline; 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

Benefits

Competitive healthcare; Voluntary benefit programs; 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 discretionary year-end shutdown; Savings and investments; Location-specific perks and extras; Eligibility for annual discretionary bonus, other incentive compensation, or equity award