Stability Operations Director - Pharmaceutical Analysis and Digital Technologies

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

Job Description

Stability Operations Director - Pharmaceutical Analysis and Digital Technologies (PADT).

Job Description:

Pharmaceutical Analysis and Digital Technologies (PADT) is seeking an exceptional scientist and leader who is passionate about leading an integrated Stability Operations organization to support clinical development, regulatory filing execution, and successful commercial transition across Biologics, Vaccines, and Small Molecule programs. The successful candidate will lead a team of scientists and operational staff responsible for establishing robust, scalable, and compliant end-to-end stability operations and will therefore require a strong focus on employee development, people management, and cross-functional influence.

As Director of Stability Operations within Analytical Capabilities and Operations (ACO - PADT), you and your team will partner with cross-functional development teams across our Research & Development Division and our Manufacturing Division to define and execute stability strategies that enable uninterrupted clinical supply, support global regulatory submissions, and ensure seamless handoffs to commercial stability organizations. The role will be accountable for building a unified operating model for clinical stability, clarifying governance across internal and external partners, standardizing stability study execution and reporting, and advancing digital and operational modernization across the stability portfolio.

The successful candidate will be responsible for proactively enabling strong partnerships between internal and external teams, including biologics and vaccines analytical development teams, External Capabilities, analytical development teams, commercial stability coordinators, Quality, Digital CMC, and our Manufacturing Division stakeholders, to drive a culture of scientific excellence, operational discipline, and inspection-ready stability execution.

Primary Responsibilities:

Responsibilities include, but are not limited to:

• Providing strategic, scientific, and operational leadership for the design, implementation, and continuous improvement of an end-to-end Stability Operations model across Biologics, Vaccines, and Small Molecule programs.
• Leading a Stability Operations team responsible for clinical stability study planning, execution, monitoring, data readiness, and operational governance across the development pipeline.
• Partnering with biologics, small molecule and vaccines analytical development teams, External Capabilities, Quality, and program teams early in development to identify stability risks and design robust clinical stability programs.
• Defining and clarifying stability-facing roles, responsibilities, governance, and ownership boundaries across internal and external groups, including deviation management and commercial transition accountabilities.
• Establishing and leading cross-divisional forums that bridge Research & Development Division and our Manufacturing Division to ensure smooth, risk-mitigated stability transitions as assets progress through validation, PPQ, registration, and launch.
• Providing operational and strategic oversight of stability content supporting IND, IMPD, NDA, and BLA filings, ensuring consistency of stability arguments, data presentation, and shelf-life justification strategies.
• Championing digital modernization of stability operations, including enhanced RLIMS2 utilization, CRO stability data workflows, automated reporting, structured data intake, and improved data visualization.
• Driving global capacity through capital build, chamber governance, inventory visibility, and space optimization activities to ensure stability storage capacity is appropriately monitored and managed.
• Actively managing a team of roughly 25 people, encouraging and facilitating their personal, scientific, and leadership development, including succession planning for future stability subject matter experts.
• Ensuring compliance with applicable Quality Management System expectations, safety procedures, training requirements, and operational compliance metrics.

Education Minimum Requirements:

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

Required Experience and Skills:

• 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, including ICH, FDA, EMA, and related CMC requirements for clinical and commercial registrations.
• Demonstrated experience guiding assets across the clinical-to-commercial boundary, including late-stage development, validation, PPQ, launch readiness, or BLA/NDA filing execution.
• Proven leadership in cross-functional, highly matrixed technical forums.