Global Stability Ops Director, Pharma Analytics & Digital

MSD; Pennsylvania; Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Hybrid work arrangements

Competitive compensation

Comprehensive benefits

Job summary

Merck & Co., Inc. is seeking a Stability Operations Director for Pharmaceutical Analysis and Digital Technologies (PADT) to lead a ~25-person team across Biologics, Vaccines, and Small Molecule programs.

You will drive end-to-end stability strategies, partner with QA, Regulatory, and Manufacturing, and advance digital modernization of stability operations. The role requires a PhD or equivalent with 8+ years (MS with 12+ or BS with 14+ years) and a proven ability to influence across a matrixed

Qualifications

• PhD or equivalent with 8+ years of relevant experience; MS with 12+ years; BS with 14+ years.
• Extensive experience designing, executing, and defending clinical stability study strategies.
• Strong understanding of global stability regulations (ICH, FDA, EMA, CMC).
• Proven leadership in matrixed, cross-functional environments across R&D and Manufacturing.

Responsibilities

• Provide strategic, scientific, and operational leadership for end-to-end stability operations across Biologics, Vaccines, and Small Molecule programs.
• Lead stability study planning, execution, monitoring, data readiness, and governance across the development pipeline.
• Partner with analytical development teams, external capabilities, quality, and program teams early in development to identify stability risks.
• Define stability-facing roles, governance, and ownership across internal and external groups.
• Develop cross-divisional forums to ensure smooth stability transitions through validation, PPQ, registration, and launch.

Skills

Leadership

Analytical chemistry

Regulatory knowledge

Cross-functional collaboration

Communication

Project management

Quality and compliance

Education

PhD in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering

MS in related field (with 12+ years experience)

BS in related field (with 14+ years experience)

Tools

RLIMS2

Benchling

GLIMS

Job description

Merck & Co., Inc. is seeking a Stability Operations Director for Pharmaceutical Analysis and Digital Technologies (PADT) to lead a ~25-person team across Biologics, Vaccines, and Small Molecule programs.

You will drive end-to-end stability strategies, partner with QA, Regulatory, and Manufacturing, and advance digital modernization of stability operations. The role requires a PhD or equivalent with 8+ years (MS with 12+ or BS with 14+ years) and a proven ability to influence across a matrixed