Research Associate II - Stability SME

Vantive; Castlebar; On-site; EUR 60,000 - 80,000; Full time

Job summary

A healthcare organization based in Ireland is looking for a Research Associate II to join their Stability team. The successful candidate will serve as a Stability Subject Matter Expert, contributing to the development of stability strategies for new and existing products. Key responsibilities include analyzing stability data, authoring technical reports, and participating in product development projects. Ideal candidates will have a background in analytical chemistry and a collaborative spirit, with a focus on improving patient outcomes.

Benefits

Comprehensive benefits package

Stable work environment

Recognition for outstanding performance

Qualifications

• Ability to organize complex information under guidance.
• Experience with analytical chemistry and FDA regulations.
• Ability to work collaboratively across time zones.

Responsibilities

• Support development of GMP stability studies.
• Author and review technical data and reports.
• Contribute to stability sections for regulatory submissions.

Skills

Attention to detail

Logical problem solving

Technical writing

Analytical chemistry proficiency

Teamwork

Education

Bachelor’s or Master’s degree in relevant scientific subject

Tools

Sophisticated databases

Job description

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 & Sciences R&D - Stability team supports R&D projects for new and existing products. We currently have an opening for a Research Associate II to represent Analytical Chemistry and Stability as a Stability Subject Matter Expert. The successful candidate would apply sound chemistry and stability planning knowledge to identify and evaluate stability indicating characteristics as part of product changes and new product development. 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 designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements.

Essential Duties And Responsibilities

• Represent R&D–Stability on project teams as a member of the project teams’ goals and success.
• Support development and implementation of stability strategies for new product development and sustaining project activities.
• Support development of GMP stability studies used to establish expiration dating and support labeling for product development.
• Contribute to the development of technical justifications for expiration dating for new or modified products and the defense 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 through use of Quality Documentation System.
• 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.
• Support development of new and/or optimization of existing processes and procedures to enhance stability related practices.
• Participate in investigations that correspond to atypical, out-of-specification, or out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data under guidance of senior Stability team members.
• Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles.
• Contribute to stability sections intended for submission to regulatory authorities under guidance of senior Stability team members. Use computerized systems to retrieve, evaluate, summarize data for reporting.

Qualifications Required

• Under guidance of senior Stability team member, able to organize complex information and demonstrate attention to detail.
• Logical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members.
• 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.
• Proficient in analytical chemistry including theoretical knowledge and practical experience.
• Willingness to contribute efforts beyond own scope of responsibilities to ensure project milestones are met.
• Basic functional understanding of FDA, ISO, and Quality systems.
• Works well in a team environment across multiple time zones and demonstrates an inclusive attitude.

Education

• Bachelor’s Degree with 2-4 years or Master’s degree in a relevant scientific subject area.

What Can Vantive Offer To You

• 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

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