Stability Operations Director - Pharmaceutical Analysis and Digital Technologies

Primary Responsibilities

• 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.