Stability Operations Director - Pharmaceutical Analysis and Digital Technologies

Location: Hybrid; primary location in West Point, Pennsylvania, United States. The role supports domestic and international relocation, requires 10% travel, and is available to United States, Canada, and Puerto Rico residents through this careers site.

Salary: $173,200–$272,600 annual base salary for the primary location, plus potential annual bonus and long-term incentive.

Company

hirify.global is a pharmaceutical company developing and manufacturing medicines, vaccines, biologics, and small-molecule products.

What you will do

• Provide strategic, scientific, and operational leadership for an end-to-end Stability Operations model across biologics, vaccines, and small-molecule programs.
• Lead a team responsible for clinical stability study planning, execution, monitoring, data readiness, and operational governance.
• Partner with analytical development, Quality, manufacturing, regulatory, external capabilities, and program teams to identify stability risks and design clinical stability programs.
• Define governance, roles, responsibilities, deviation management, and ownership boundaries across internal and external groups.
• Lead cross-divisional forums supporting transitions through validation, PPQ, registration, and launch, including stability content for IND, IMPD, NDA, and BLA filings.
• Advance digital stability operations through RLIMS2 utilization, CRO data workflows, automated reporting, structured data intake, data visualization, chamber governance, inventory visibility, and space optimization.

Requirements

• Ph.D. in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Chemical Engineering, or a related scientific discipline with 8+ years of relevant experience; or MS with 12+ years; or BS with 14+ years.
• 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.
• 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 the ability to influence research, development, manufacturing, Quality, regulatory, and external partner stakeholders.
• Experience applying quality principles, deviation management, inspection readiness practices, and compliant documentation standards in a GxP-facing scientific environment.
• Ability to manage inclusive scientific and operational teams and attract, develop, and retain diverse talent.
• Excellent verbal and written communication skills and ability to work in a team-based, fast-paced, dynamic environment.

Nice to have

• Experience across biologics, vaccines, and small molecules.
• Experience implementing digital transformation in laboratory or stability operations, including RLIMS2, Benchling, Signals, GLIMS, automated data pipelines, or structured regulatory authoring systems.
• Experience 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 stability subject matter experts.

Culture & Benefits

• Hybrid work arrangement with a regular, inclusive, and collaborative work environment.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Inclusive workplace focused on diverse perspectives, respectful challenge, and collective problem-solving.

Hiring process

• Applications are submitted through the hirify.global careers platform.
• Accommodation support is available during the application and hiring process for eligible candidates.