Stability Ops Director, Pharma Analytics & Digital

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

Job summary

Merck & Co. is seeking a Director of Stability Operations within Analytical Capabilities and Operations (PADT) to lead an integrated stability organization across Biologics, Vaccines, and Small Molecule programs.

You will partner with Research & Development and Manufacturing to define stability strategies enabling uninterrupted clinical supply, successful regulatory submissions, and smooth handoffs to commercial stability groups. The role emphasizes people leadership and continuous improvement.

Qualifications

• PhD or MS/BS with relevant experience in stability operations and clinical to commercial transitions.
• Experience designing and leading stability strategies for biologics, vaccines, or small molecules.
• Strong cross-functional leadership across R&D, manufacturing, quality, and regulatory.

Responsibilities

• Provide strategic scientific and operational leadership for end-to-end Stability Operations across modalities.
• Lead stability study planning, execution, monitoring, data readiness, and governance.
• Partner with development teams to identify stability risks and design robust clinical programs.

Skills

Leadership

Analytical Chemistry

Regulatory Compliance

Cross-functional Collaboration

GxP

Quality Management

Education

PhD in Chemistry/Pharmaceutical Sciences

MS in related field

BS in related field

Tools

RLIMS2

Benchling

GLIMS

Regulatory Submissions Tools

Job description

Merck & Co. is seeking a Director of Stability Operations within Analytical Capabilities and Operations (PADT) to lead an integrated stability organization across Biologics, Vaccines, and Small Molecule programs.

You will partner with Research & Development and Manufacturing to define stability strategies enabling uninterrupted clinical supply, successful regulatory submissions, and smooth handoffs to commercial stability groups. The role emphasizes people leadership and continuous improvement.