Associate Director, Stability Strategy—Development & Clinical

RXinsider LTD.; Norwood (MA); On-site; USD 143,000 - 257,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Family planning

Paid time off

Savings opportunities

Location perks

Job summary

Moderna in Norwood, MA, is seeking a Stability Leader to define and execute phase-appropriate stability strategies across development, clinical, and commercial products. You will work as a cross-functional SME, translating stability data into program, regulatory, and supply decisions, while mentoring teams and driving continuity of supply.

This role blends scientific rigor with regulatory acumen, leveraging digital tools and analytics to optimize shelf-life and ensure successful regulatory

Qualifications

• Bachelor’s degree with 12 years’ experience or PhD with 5 years’ experience.
• Experience leading stability strategy for biologics, vaccines, or complex drug products.
• Authoring stability content for regulatory submissions.
• Strong cross-functional collaboration in CMC teams.
• Experience with ICH guidelines and regulatory expectations.

Responsibilities

• Define and lead phase-appropriate stability strategies aligned to program objectives.
• Design stability protocols and study plans for regulatory submissions.
• Lead stability data review and trend analysis for expiry dating.
• Collaborate with Analytical Development, Quality, Regulatory, Clinical Supply, and Supply Chain.
• Mentor teams and drive stability governance and improvements.

Skills

Cross-functional leadership

Stability data analysis

Statistical interpretation

Regulatory knowledge

Project management

Education

Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmaceutical Sciences, or related technical discipline

Job description

Moderna in Norwood, MA, is seeking a Stability Leader to define and execute phase-appropriate stability strategies across development, clinical, and commercial products. You will work as a cross-functional SME, translating stability data into program, regulatory, and supply decisions, while mentoring teams and driving continuity of supply.

This role blends scientific rigor with regulatory acumen, leveraging digital tools and analytics to optimize shelf-life and ensure successful regulatory