Senior Stability Lead for Development & Clinical Programs
BioSpace
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Benefits offered by this job
Job summary
Moderna in Norwood, MA is seeking a Stability Leader to define and execute phase-appropriate stability strategies across a diverse mRNA portfolio from development through commercial. You will lead cross-functional teams, oversee stability protocols, and author stability sections for regulatory submissions, ensuring regulatory readiness and uninterrupted patient supply.
This role blends scientific rigor with strategic leadership, leveraging advanced analytics and AI capabilities to enhance
Qualifications
- Degree in Life Sciences or related discipline.
- 12 years of relevant experience with Bachelor's degree or 5 years with PhD.
- Experience leading stability strategy for biologics, vaccines, or complex drug products.
Responsibilities
- Define and lead phase-appropriate stability strategies aligned to program objectives.
- Design and oversee stability protocols and study plans for regulatory submissions.
- Ensure stability strategies comply with ICH guidance and regulatory expectations.
- Lead stability data review, including statistical evaluation and trending analysis.
- Identify degradation trends and supply risks; drive cross-functional mitigation.
- Author and review stability sections for regulatory submissions and responses.
Skills
Education
Job description
Moderna in Norwood, MA is seeking a Stability Leader to define and execute phase-appropriate stability strategies across a diverse mRNA portfolio from development through commercial. You will lead cross-functional teams, oversee stability protocols, and author stability sections for regulatory submissions, ensuring regulatory readiness and uninterrupted patient supply.
This role blends scientific rigor with strategic leadership, leveraging advanced analytics and AI capabilities to enhance
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