Stability Subject Matter Expert/Research Associate III

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

The Kidney Care R&D - Stability team supports R&D projects for new and existing products. We currently have an opening for a Research Associate III to represent Kidney Care Solutions as a Stability Subject Matter Expert. The successful candidate would apply 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 designs strategies and makes recommendations that are non-routine to address technical, regulatory, and business requirements.

What you'll be doing

• Represent R&D-Stability on project teams as a key member of the project teams' goals and success.
• Collaborate with vital team members (e.g., Product Design Owners, Project Managers, Regulatory Affairs, Quality) to anticipate business needs and gain alignment.
• 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.
• Supply 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.
• Partner with manufacturing facilities, analytical chemistry teams, and stability testing labs to 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.
• Identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.
• 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.
• Successfully plan, coordinate, and lead all aspects of the progress of multiple Stability related projects, budgets, and activities working with global teams and CROs as applicable.
• Supply to and/or take lead author role for stability sections intended for submission to regulatory authorities. Use computerized systems to retrieve, evaluate, and summarize data for reporting.
• Supply to efforts beyond own scope of responsibilities to ensure project landmarks are met.

• Ability to apply logical, methodical approaches in order to independently solve problems, develop solutions, and make 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.
• Functional understanding of FDA, ISO, and Quality systems.

Bachelor's Degree with 5+ years of experience or, Master's with 3+ years, or PhD 1+ years of experience in a relevant scientific subject area.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $96,000 to $132,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

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