Research Associate III - Stability SME

Research Associate III - Stability SME at Vantive summary:

The Research Associate III - Stability SME at Vantive applies advanced chemistry and stability expertise to support R&D projects for new and existing drug products, ensuring product shelf life and regulatory compliance. Responsibilities include designing and implementing stability strategies, conducting GMP stability studies, authoring technical reports, and coordinating stability projects globally. This role involves collaboration with manufacturing, regulatory teams, and CROs to optimize stability methods and address technical and business requirements.

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.

YOUR ROLE

The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products. The Research Associate III, 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.

WHAT YOU WILL BE DOING

• 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 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.

• 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,…