Testing Coordinator/Research Associate III

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our 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 sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Your role

The Renal Solutions and Containers - Analytical Chemistry and Stability team supports Renal Care and Acute Therapy R&D projects. We now have a vacancy for a Stability Study Coordinator to own operational excellence and continuous improvement; streamline processes; coordinate business, management, and technical SMEs; identify risks; devise solutions, all to support the establishment of shelf life for new and existing products. The successful candidate will effectively supply solid technical knowledge to a variety of projects within the relevant subject area with minimal assistance and display basic technical understanding of related fields including:

• Display an understanding of theories/practice used by other fields outside the primary area of expertise.
• Focus on innovation, process improvement, and/or operational excellence initiatives.
• Conducts research or designs strategies to achieve the technical vision for a new or improved product/process/method or to prove a new theory, applying a solid understanding of theories/practices including those from other fields outside the primary area of expertise.
• Studies, designs, and recommendations reflect impact by and to diverse subject areas.

What you'll be doing

• Process inputs from Global Stability Functional Leader and Stability SMEs to resolve schedules and forecast resource allocations to projects.
• Ensure the right methods and specifications are available for stability testing.
• Coordinate testing with global teams and CROs as applicable.
• Interact with other testing groups (Particle, Sterility/BET, etc.) to resolve schedules and alignment with business needs/function commitments.
• Collaborate with other functions such as project management, regulatory, extractables, manufacturing and quality in project teams.
• Participate in detailed planning of Registration Stability Test lab, and if approved, lead the implementation.
• Participate in investigations that correspond to atypical or out-of-specification/out-of-trend results. Review data and author technical evaluations that characterize the stability trending of suspect data. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
• Create, update, and maintain equipment and analytical procedures.
• Independently plan, implement, and lead projects/programs that both span multiple subject areas and use established methods, techniques, or approaches.
• In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, provides authoritative advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.

What you'll bring

• Experience with analytical method development, validation and transfer.
• A good understanding of ICH, USP guidelines and cGxP practice.
• Experience with ICP-MS, ICP-OES, IC, AA, UHPLC/HPLC, GC, UV, Polarimeter, (NMR a plus) and other analytical instruments and software (Open Lab, ELN, Empower).
• Apply a logical, methodical approach in independently solving problems, developing solutions, and making recommendations.
• Possess basic understanding of analytical chemistry including theoretical knowledge and practical experience.
• Possess understanding of manufacturing documents.
• Possess strong time management and project management skills.
• Functional understanding of FDA, ISO and Quality systems.
• Experience working with complex databases would be a bonus.

Education and/or Experience:

Bachelor’s Degree with 5+ years of experience, Master’s Degree with 3+ years of experience, or PhD with 1+ years of experience in chemistry.

Analytical lab experience, cGxP experience, cross-functional teamwork, and independent experimentation in method development and validation.

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. 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.

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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

Baxter 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.

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