Job description

About the Role

HERO Recruitment is seeking a Stability Specialist to join their team in County Mayo, Ireland. This role is crucial for applying chemistry and stability planning expertise to identify and resolve stability-indicating characteristics. The successful candidate will integrate chemistry and stability knowledge to establish shelf life for new and existing products, supporting rapidly growing markets and qualifying product changes globally. The Stability Subject Matter Expert will develop and design innovative strategies and provide recommendations to meet technical, regulatory, and business requirements.

Responsibilities

Serve as a key R&D–Stability representative on project teams, contributing to their overall success.
Develop and execute comprehensive stability strategy plans for both new product development and ongoing projects.
Design Good Manufacturing Practice (GMP) stability studies essential for determining product expiration dates.
Contribute to the creation of technical justifications for expiration dating of new or modified products, and effectively defend these recommendations to stakeholders.
Provide critical input for stability assessments and define requirements for new products and changes to existing products.
Ensure the availability and appropriateness of testing methods and specifications for stability, compatibility, and release testing, verifying their suitability throughout the product's shelf life.
Proactively identify risks, issues, and opportunities for enhancing existing methods, technologies, and approaches, backing these with robust scientific reasoning.
Collaborate with manufacturing facilities to gather necessary information regarding test methods and specifications.
Author, review, and validate technical data, protocols, and reports.
Act as a study director for stability projects under the supervision of senior team members.
Manage stability study administration within LIMS, including study setup, review, identifying data requiring modification, and data entry.
Develop novel processes and optimize existing ones to improve stability-related practices.
Participate in investigations of atypical or out-of-specification/out-of-trend test results, reviewing data and authoring technical evaluations to characterize stability trends.
Utilize critical thinking to guide investigations to conclusions based on sound scientific principles.
Effectively plan, coordinate, and oversee multiple stability projects, budgets, and activities, collaborating with global teams and Contract Research Organizations (CROs).
Contribute to or lead the authoring of stability sections for regulatory submissions, using computerized systems for data retrieval, evaluation, and summarization for reporting.

Qualifications and Skills

Possess a Bachelor’s Degree, Master’s, or PhD in a relevant scientific field.
Demonstrate strong organizational skills for managing complex information and meticulous attention to detail.
Apply a logical, methodical approach to independently solve problems, develop solutions, and make well-reasoned recommendations.
Experience working with advanced databases.
Proficiency in relevant computer skills, including word processing, spreadsheets, table and graph generation, and database/reporting tools.
Excellent technical writing capabilities.
Solid understanding and practical experience in analytical chemistry.
Willingness to contribute beyond immediate responsibilities to ensure project milestones are achieved.
Functional knowledge of FDA, ISO, and Quality systems.
Ability to work effectively in a team environment across different time zones, demonstrating an inclusive attitude.

Additional Information

This role requires the application of sound chemistry and stability planning expertise to identify and resolve stability-indicating characteristics. The effective integration of chemistry and stability enables the establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert develops and designs strategies and makes recommendations that are non-routine to address technical, regulatory, and business requirements.