Stability Ops Director - Pharma Analysis & Digital (Hybrid)

Merck & Co., Inc.; West Point (PA); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in USA - Pennsylvania - West Point seeks an exceptional scientist and leader to head Stability Operations within PADT, guiding end-to-end stability programs for biologics, vaccines, and small molecules.

You will manage a team of ~25, drive governance across internal and external partners, and advance digital modernization to enable uninterrupted clinical supply and successful regulatory filings.

Qualifications

• Design, execution, and defense of clinical stability strategies across biologics, vaccines, and small molecules.
• Global stability regulations and CMC requirements (ICH, FDA, EMA).
• Leadership in cross-functional forums and influence across R&D, manufacturing, quality, regulatory, and external partners.
• Quality principles, deviation management, and inspection readiness in a GxP environment.
• Ability to mentor and develop future stability experts.
• Excellent written and verbal communication in a fast-paced environment.

Responsibilities

• Provide strategic, scientific, and operational leadership for end-to-end Stability Operations.
• Lead stability study planning, execution, monitoring, data readiness, and governance.
• Partner with development teams and external capabilities to identify stability risks.
• Define stability-facing roles, governance, and ownership across groups.
• Drive cross-divisional forums bridging R&D and Manufacturing for smooth transitions.
• Oversee stability content supporting IND/IMPD/NDA/BLA filings.
• Advance digital modernization including RLIMS2 and automated reporting.
• Ensure capacity, inventory visibility, and space optimization for storage.

Skills

Clinical stability

Cross-functional leadership

Strategic leadership

Quality systems

Communication

Team development

Education

PhD in Chemistry/Pharmaceutical Sciences

MS in related field

BS in related field

Tools

RLIMS2

Benchling

Signals

GLIMS

Automated data pipelines

Job description

Merck & Co., Inc. in USA - Pennsylvania - West Point seeks an exceptional scientist and leader to head Stability Operations within PADT, guiding end-to-end stability programs for biologics, vaccines, and small molecules.

You will manage a team of ~25, drive governance across internal and external partners, and advance digital modernization to enable uninterrupted clinical supply and successful regulatory filings.