Stability Specialist

Vantive; Castlebar; Vor Ort; EUR 75.000 - 95.000; Vollzeit

Benefits dieser Stelle

Private medical insurance

Company pension scheme

Annual bonus scheme

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Attention to detail

Analytical chemistry

Technical writing

Problem solving

Team collaboration across time zones

Ausbildung

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

Tools

Word processing

Spreadsheets

Databases

Reporting tools

Jobbeschreibung

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products. The Stability Specialist, 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 Specialist 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 of the project teams' goals and success.
• Craft and implement stability strategy plans for new product development and sustaining projects.
• Design GMP stability studies used to establish expiration dating for product development.
• Contribute to the development of technical justifications for expiration dating for new or modified products and the defence of expiration dating recommendation to key business partners.
• Provide valuable input to stability assessments and requirements for new products and/or current product changes.
• Ensure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life.
• Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.
• Interact with manufacturing facilities to acquire information related to test methods and specifications.
• Author, review and verify technical data, protocols, and reports.
• Act as study director for stability projects under guidance of senior Stability team members.
• Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.
• Develop new and/or optimize existing processes and procedures to enhance stability related practices.
• 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.
• Optimally plan, coordinate, and oversee the progress of multiple Stability related projects, budgets, and activities working with global teams and CROs as applicable.
• Contribute to and/or take lead author role for stability sections intended for submission to regulatory authorities. Use computerized systems to retrieve, evaluate, summarize data for reporting.

Education and experience required:

• Bachelor's Degree, Master's or PhD with experience in a relevant scientific subject area.
• Ability to organize complex information and demonstrated attention to detail.
• 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, and use of databases and reporting tools.
• Good technical writing skills.
• Possess proficiency in analytical chemistry including theoretical knowledge and practical experience.
• Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Functional understanding of FDA, ISO, and Quality systems.
• Willingness to work in a team environment across multiple time zones and demonstrates an inclusive attitude.

What Vantive can offer to you:

• Join a new and growing R&D team based at our Castlebar site.
• A permanent contract with a stable and secure work environment.
• A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme.
• A collaborative and dynamic work environment.
• Access to state-of-the-art equipment and technology.
• Recognition and reward for outstanding performance.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link