Stability Operations Director, Pharma Analysis & Digital Tech

Merck; West Point (PA); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck seeks a Director of Stability Operations within PADT to lead end-to-end stability programs across biologics, vaccines, and small molecules, partnering with R&D and Manufacturing. You will build a unified operating model, govern stability study execution, and advance digital modernization while developing a team of ~25 and ensuring regulatory readiness.

This role requires strong cross-functional leadership, deep regulatory knowledge, and a track record of delivering inspection-ready

Qualifications

• Ph.D. in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering, or related discipline with 8+ years of relevant experience.
• MS degree with 12+ years of relevant experience.
• BS degree with 14+ years of relevant experience.
• Extensive experience designing, executing, and defending clinical stability study strategies for Biologics, Vaccines, or Small Molecule programs.
• Strong understanding of global stability regulations and expectations (ICH, FDA, EMA, CMC).
• Experience guiding assets across clinical-to-commercial boundary (late-stage development, validation, PPQ, launch readiness, or BLA/NDA).
• Proven leadership in cross-functional, matrixed technical forums.

Responsibilities

• Provide strategic, scientific, and operational leadership for end-to-end stability operations across Biologics, Vaccines, and Small Molecules.
• Lead a stability operations team for clinical stability study planning, execution, monitoring, data readiness, and governance.
• Partner with analytics, 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.
• Establish cross-divisional forums to ensure smooth stability transitions from validation to launch.
• Oversee stability content for IND, IMPD, NDA, and BLA filings with consistent arguments and shelf-life justifications.

Skills

Leadership

Cross-functional collaboration

Strategic planning

Regulatory knowledge

Education

PhD in Chemistry/Pharmaceutical Sciences/related

MS with 12+ years experience

BS with 14+ years experience

Job description

Merck seeks a Director of Stability Operations within PADT to lead end-to-end stability programs across biologics, vaccines, and small molecules, partnering with R&D and Manufacturing. You will build a unified operating model, govern stability study execution, and advance digital modernization while developing a team of ~25 and ensuring regulatory readiness.

This role requires strong cross-functional leadership, deep regulatory knowledge, and a track record of delivering inspection-ready