Stability Scientist, Pharma R&D — Global Impact

Vantive; Castlebar; On-site; EUR 75,000 - 95,000; Full time

Benefits offered by this job

Private medical insurance

Company pension scheme

Annual bonus scheme

Job summary

Vantive is a vital organ therapy company, advancing dialysis with digital solutions and global reach. The Stability Specialist develops strategies and conducts stability studies to establish shelf life for products and supports regulatory submissions.

The role involves cross-functional teamwork, data review, and coordinating with manufacturing and CROs across time zones. A strong water–ed chemistry background and FDA/ISO quality systems experience are required.

Qualifications

• Bachelor's Degree, Master's or PhD with experience in a relevant scientific subject area.
• Ability to organize complex information and demonstrate attention to detail.
• Logical, methodical problem solving in independent settings.
• Experience working with sophisticated databases.
• Proficient with word processing, spreadsheets, databases and reporting tools.
• Strong technical writing skills.
• Proficiency in analytical chemistry and practical application.
• Contribute to project milestones beyond own scope.
• Familiarity with FDA, ISO and Quality systems.

Responsibilities

• Represent R&D-Stability on project teams as a key member of goals and success.
• Craft and implement stability strategy plans for new development and sustaining projects.
• Design GMP stability studies to establish expiration dating.
• Provide justification for expiration dating to partners.
• Input stability assessments and requirements for product changes.
• Ensure methods and specs support stability, compatibility, and release testing.
• Identify risks and opportunities to improve methods and approaches.
• Interact with manufacturing for test methods and specifications.
• Author, review and verify technical data, protocols and reports.
• Act as study director for stability projects under senior guidance.
• Manage stability study administration in LIMS and data entry.
• Develop new or optimize stability-related processes and procedures.
• Participate in investigations of out-of-spec results and stability trends.
• Drive investigations with sound scientific principles.
• Coordinate multiple stability projects with global teams and CROs.
• Lead author stability sections for regulatory submissions.

Skills

Attention to detail

Analytical chemistry

Technical writing

Problem solving

Team collaboration across time zones

Education

Bachelor's/Master's/PhD in a relevant science

Tools

Word processing

Spreadsheets

Databases

Reporting tools

Job description

Vantive is a vital organ therapy company, advancing dialysis with digital solutions and global reach. The Stability Specialist develops strategies and conducts stability studies to establish shelf life for products and supports regulatory submissions.

The role involves cross-functional teamwork, data review, and coordinating with manufacturing and CROs across time zones. A strong water–ed chemistry background and FDA/ISO quality systems experience are required.