Stability Operations Director - Pharmaceutical Analysis and Digital Technologies

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 and ability to influence stakeholders across research, development, manufacturing, quality, regulatory, and external partner organizations. 

• Experience applying quality principles, deviation management expectations, inspection readiness practices, and compliant documentation standards within a GxP-facing scientific environment. 

• A strong aptitude for managing inclusive scientific and operational teams and attracting, developing, and retaining diverse talent. 

• Excellent verbal and written communication skills and an ability to excel in a team-based, fast-paced, and highly dynamic environment. 

Preferred Experience and Skills: 
 

• Experience across multiple modalities, including Biologics, Vaccines, and Small Molecules. 

• Experience implementing digital transformation initiatives in laboratory or stability operations, including RLIMS2, Benchling, Signals, GLIMS, automated data pipelines, or structured regulatory authoring systems. 

• Proven track record establishing operational governance, standardized ways of working, and continuous improvement programs across complex scientific organizations. 

• Experience building training curricula, mentoring technical leaders, and developing future subject matter experts within a scientific functional area. 

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The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.