Sr. Manager, CMC Stability Lead
About The Position
We are seeking a strong scientific and operational stability leader to support stability strategy execution across Moderna’s portfolio. This role will contribute to the design and management of stability studies, interpretation of stability data, shelf-life recommendations, and regulatory support for assigned development, clinical, or commercial programs to help advance programs, maintain compliant product control strategies, and support uninterrupted supply. This is an onsite role based in Moderna’s Technology Center campus in Norwood, MA. In this role, you will work as a program-facing stability lead who partners closely with cross-functional teams to translate stability data into clear, actionable decisions. You will help design studies, evaluate trends, support shelf-life assignments, prepare regulatory content, and drive timely resolution of stability-related issues within either a development/clinical or commercial scope, depending on business need. You will be expected to operate with strong scientific judgment and increasing independence while collaborating effectively across Analytical Development, Quantitative Sciences, Process Development, Quality, Regulatory, Clinical Supply, Supply Chain, and Commercial teams, as relevant to your assigned programs.
Requirements
- Degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline
- 10 years of relevant experience with Bachelor’s degree or 2 years of relevant experience with a PhD.
Nice To Haves
- Advanced degree in a relevant field is preferred combined with a 4+ years of relevant industry experience
- Experience supporting stability programs for biologics, vaccines, or other complex drug products in either development/clinical or commercial settings.
- Experience authoring or contributing to stability sections for regulatory submissions and responses.
- Strong background in stability data interpretation, statistical analysis, and shelf-life assessment.
- Experience working in cross-functional CMC teams within a matrixed development or commercial environment.
- Familiarity with ICH stability guidance and global regulatory expectations related to expiry dating, storage conditions, and post-approval commitments.
- Experience supporting stability-related investigations, risk assessments, and change evaluations.
- Ability to communicate clearly, influence constructively, and manage multiple priorities in a fast-paced environment.
- Strong organizational skills and a demonstrated ability to drive execution with a high degree of accountability.
- Experience with development and clinical programs, or with commercial lifecycle management, annual product quality review support, or expiry-risk management, is preferred.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Responsibilities
- Define and execute stability strategies for assigned development, clinical, or commercial programs in alignment with program goals, regulatory expectations, and business needs.
- Design stability protocols and study plans to support clinical progression, registration activities, commercial maintenance, or selected lifecycle management initiatives, as applicable to assigned programs.
- Review and interpret stability data, perform trending analyses, and support statistical evaluations to identify product trends, risks, and opportunities.
- Generate and communicate recommendations for shelf-life assignment, expiry updates, storage conditions, and stability risk mitigation based on available data.
- Support stability-related input into formulation, process development, control strategy, and change-management discussions, as relevant to assigned programs.
- Author and contribute to stability sections for regulatory submissions, responses, and technical documentation, including clinical, registration, and post-approval materials, as applicable.
- Partner with Clinical Supply, Supply Chain, and other stakeholders to help manage stability milestones, inventory risk, and expiry-related planning.
- Lead or support investigations for stability-related OOS/OOT events and partner with Quality to ensure timely, compliant resolution.
- Maintain high standards of data integrity, documentation quality, and inspection readiness for stability-related records and deliverables.
- Collaborate across cross-functional CMC teams to align study execution, issue management, and decision-making with broader program priorities.
- Identify and implement opportunities to improve stability processes, tracking, reporting, and team effectiveness.
- Additional duties as may be assigned from time to time.
Benefits
- Competitive healthcare, 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 investments to help you plan for the future
- Location-specific perks and extras
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Associate degree
