Research Associate II

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 II, Stability Subject Matter Expert, applies sound chemistry and stability planning knowledge to identify and evaluate 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 designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements.

WHAT YOU WILL BE DOING

• 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.

WHAT YOU WILL BRING

• 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 and/or Experience:

Bachelor's Degree with 8-12 years or Master's degree with 6-10 Years in a relevant scientific subject area.

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.