Stability Operations Director—Pharma Analytics & Digital Tech

MSD; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Job summary

MSD is seeking a Stability Operations Director to lead an integrated program across Biologics, Vaccines, and Small Molecules. You will build a unified operating model, govern internal and external partners, and drive digital modernization to enable uninterrupted clinical supply and smooth handoffs to commercial stability teams.

You will manage ~25 staff, develop talent, and oversee IND/IMPD/NDA/BLA support in a fast-paced, matrix environment, ensuring compliance and inspection readiness.

Qualifications

• Ph.D. in Chemistry or related field with extensive experience in stability.
• MS with 12+ years in stability operations or related field.
• BS with 14+ years in stability or pharmaceutical development.

Responsibilities

• Lead end-to-end stability operations across biologics, vaccines, and small molecules.
• Oversee stability study planning, execution, monitoring, and data readiness.
• Partner with cross-functional teams to identify stability risks and design programs.
• Define governance and ownership across internal/external groups.
• Drive digital modernization and RLIMS2 utilization in stability operations.
• Ensure compliance with QMS, safety, and regulatory submission readiness.

Skills

Analytical Chemistry

People Leadership

Regulatory Submissions

Stability Studies

Team Leadership

Cross-functional influence

Education

Ph.D. in Chemistry/Pharmaceutical Sciences/related field

MS and 12+ years experience

BS and 14+ years experience

Tools

RLIMS2

Benchling

GLIMS

Automated data pipelines

Job description

MSD is seeking a Stability Operations Director to lead an integrated program across Biologics, Vaccines, and Small Molecules. You will build a unified operating model, govern internal and external partners, and drive digital modernization to enable uninterrupted clinical supply and smooth handoffs to commercial stability teams.

You will manage ~25 staff, develop talent, and oversee IND/IMPD/NDA/BLA support in a fast-paced, matrix environment, ensuring compliance and inspection readiness.