Stability Leader at Moderna

Compensation

$130,800 – $209,400/yr

Setup: Hybrid
Location: Norwood, Massachusetts
Type: Full-time
Level: Lead

Description

Moderna is seeking a Stability Leader to develop and execute phase-appropriate stability strategies across various mRNA programs, ranging from development to commercial stages. The role involves acting as a scientific expert, interpreting stability data to inform regulatory, supply, and lifecycle decisions, and collaborating with cross-functional teams to ensure robust product control strategies.

Required Skills

stability strategies
stability data
statistical evaluation
shelf-life assignment
regulatory submissions
technical documentation
OOS/OOT events
data integrity
documentation quality
inspection readiness
digital tools
advanced analytics
generative AI capabilities

Additional Information

Required Previous Experiences: 10 years of relevant experience with Bachelor’s degree or 2 years of relevant experience with a PhD.
Preferred Qualifications: 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.