Stability Ops Director - Pharma Analytics & Digital Tech

MSD; West Point (PA); Hybrid; GBP 130,000 - 205,000; Full time

Job summary

Merck & Co., Inc. in the United States seeks a Director of Stability Operations to lead an integrated stability program across Biologics, Vaccines, and Small Molecules.

You will oversee a team of scientists and staff, drive governance, and partner with R&D and Manufacturing to enable uninterrupted clinical supply and regulatory submissions. You will champion digital modernization of stability workflows, contribute to regulatory strategies, and build a resilient operating model for clinical

Qualifications

• Ph.D. in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering, or related field with 8+ years of experience.
• MS degree with 12+ years of relevant experience.
• BS degree with 14+ years of relevant experience.

Responsibilities

• Provide strategic, scientific, and operational leadership for end-to-end Stability Operations across Biologics, Vaccines, and Small Molecule programs.
• Lead a Stability Operations team responsible for clinical stability planning, execution, monitoring, data readiness, and governance.
• Partner with development teams and external partners to identify stability risks and design robust stability programs.
• Define governance and ownership across internal and external groups, including deviation management.
• Lead cross-divisional forums to ensure smooth stability transitions from validation to launch.

Skills

Analytical Chemistry

Analytical Functions

Analytical Method Development

Biologics

Biologics License Application (BLA)

Chemistry

Regulatory Submissions

Stability Studies

People Leadership

Education

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

MS degree

BS degree

Tools

RLIMS2

Benchling

Signals

GLIMS

Data pipelines

Regulatory authoring

Job description

Merck & Co., Inc. in the United States seeks a Director of Stability Operations to lead an integrated stability program across Biologics, Vaccines, and Small Molecules.

You will oversee a team of scientists and staff, drive governance, and partner with R&D and Manufacturing to enable uninterrupted clinical supply and regulatory submissions. You will champion digital modernization of stability workflows, contribute to regulatory strategies, and build a resilient operating model for clinical