Stability Scientist

Role overview

This role is focused on chemistry-led stability planning and scientific evaluation to help define shelf life, support product changes, and back technical decisions for products in expanding global markets. The Stability Scientist acts as a subject matter expert, creating practical and defensible approaches to address technical, compliance, and business needs.

Key responsibilities

• Serve as the R&D Stability representative on project teams and contribute to project goals and overall delivery.
• Create and put into practice stability strategies for both new product development, including clinical trial material, and ongoing sustaining work.
• Plan GMP stability studies that support expiry dating and product labelling decisions during development.
• Prepare scientific rationales for expiry dating on new or changed products and present these recommendations to business stakeholders.
• Carry out stability evaluations for new products and for changes to existing products.
• Confirm that appropriate methods and specifications are selected for stability, compatibility, and release testing, and that they suit the product design over its shelf life.
• Spot risks, challenges, and opportunities to improve current processes, technologies, and working methods, using strong scientific reasoning.
• Work with manufacturing sites to gather test method details, specifications, and historical stability information where needed.
• Act as study director for stability programs, including trend analysis of stability data, and review, author, or verify technical documents and data.
• Plan, coordinate, and monitor multiple complex stability projects, including budget forecasting and work with global teams and CROs when relevant.
• Ensure sample shipment requirements are met between manufacturing and testing locations, including CROs.
• Draft stability sections for regulatory filings that are scientifically robust and aligned with regulatory and industry expectations.
• Partner with stakeholders to help deliver method transfer, validation, and verification activities on schedule so R&D stability work can proceed as planned.
• Take part in investigations of atypical, out-of-specification, or out-of-trend results, review data, and produce technical assessments of suspicious trends or findings.
• Apply strong critical thinking and scientific judgment to drive investigations toward clear conclusions.
• Use deep knowledge of cGxP and related guidance to advise on, help create, review, adopt, and interpret applicable regulations.
• Improve and refine stability-related procedures and workflows through process development and optimization.
• Mentor and support junior members of the R&D stability team.
• Carry out stability administration tasks in LIMS, including study creation, review, product test data setup, identifying records needing correction, and data entry.

Qualifications

A bachelor’s degree in a scientific discipline is required; a master’s degree or PhD in a relevant field is also acceptable and preferred for the role context.

Required skills and knowledge

• Strong ability to structure complex information accurately and maintain close attention to detail.
• Capability to make sound decisions with limited information and handle routine decisions independently.
• Logical, methodical problem-solving with the ability to build workable recommendations.
• Experience using advanced databases and related systems.
• Good computer literacy, including word processing, spreadsheets, charting and graphing, statistics, and database/reporting tools.
• Excellent verbal communication and technical writing ability.
• Solid knowledge of ICH, CPMP, USP, EP, Asian guidelines, cGxP practices, US and EU stability regulations, ISO requirements, and quality systems.
• Practical and theoretical competence in analytical chemistry.
• Willingness to contribute beyond assigned responsibilities to keep milestones on track.
• Comfort working in diverse, cross-functional teams across multiple time zones with an inclusive approach.

Additional information

This is a full-time onsite position based in County Mayo, Ireland.

No salary, stipend, start date, or application deadline was provided in the source information.