Stability Scientist - SME
Co. Mayo, Ireland

The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products. The Research Scientist II, Stability Subject Matter Expert, applies sound chemistry and stability planning expertise to identify and resolve stability indicating characteristics. The effective integration of chemistry and stability enables 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.

Duties and responsibilities:

• Represent R&D–Stability on project teams as a key member to achieve the project team’s goals and success.
• Design and implement stability strategies for new product development, including clinical trials, and sustaining projects.
• Design GMP stability studies used to establish expiration dating and support desired product labelling for product development.
• Develop technical justifications for setting expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners.
• Perform stability assessments to determine/evaluate requirements for new products and/or current product changes.
• Ensure the right methods and specifications are used for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life.
• Identify risks, issues, and opportunities for improvement of existing processes, technologies, and approaches. Provide sound scientific rationale.
• Interact with manufacturing facilities to acquire information related to test methods and specifications and historical stability data, where appropriate.
• Act as study director for stability projects and perform stability data trend analyses on stability studies for new, modified, or sustaining products. Study director responsibilities include authoring, reviewing and/or verifying technical documents and data.
• Optimally plan, coordinate and oversee the progress of multiple complex Stability related projects, including budget forecasting, and activities working with global teams and CROs as applicable.
• Responsible for ensuring requirements for sample shipments between the manufacturing and testing facilities, including CROs.
• Author stability sections intended for regulatory submissions that are technically sound and comply with regulatory and industry standards.
• Collaborate with stakeholders to assist in successful completion of method transfer/validation/verification activities on time to facilitate execution of R&D stability studies as per schedule.
• Participate in investigations that correspond to atypical or out-of-specification/out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data. Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles.
• In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidances, provides expert advice and/or actively participates in the generation, review, adoption and interpretation of such regulations.
• Develop new and/or optimize existing processes and procedures to enhance stability related practices.
• Coach and mentor junior members in R&D stability.
• Perform stability study administration activities on LIMS including study building and review, product test data creation, identification of product test data requiring modification, and data entry.

Education and experience required:

• Bachelor’s degree in a scientific discipline, Master’s degree or PhD in relevant discipline is required.
• Ability to organize complex information and demonstrate attention to detail.
• Ability to make decisions when provided with limited information and to make routine decisions independently.
• Apply a logical, methodical approach in independently solving problems, developing solutions, and making sound recommendations.
• Experience working with sophisticated databases.
• Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, statistics, and use of databases and reporting tools.
• Possess strong verbal and technical writing skills.
• Possess a good understanding of ICH, CPMP, USP, EP, Asian guidelines and cGxP practice in addition to US and EU stability regulations, ISO requirements, and Quality systems.
• Possess proficiency in analytical chemistry including theoretical knowledge and practical experience.
• Willingness to contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Willingness to work in a diverse team environment across multiple time zones and demonstrates an inclusive attitude.