Research Associate III
3 weeks ago
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.
Summary:
Support the Extractables and Leachables scientific excellence of the Renal R&D. As a senior scientist, oversee the use of state-of-the-art technology (LC-MS, GC-MS, GC, ICP-MS, ICP-OES, UV, LC, IC) to solve complex analytical problems & investigations, including Structure Elucidation. Ensure technical capabilities and expertise are aligned with business needs to sustain products, support development of new products, contribute to investigations, and drive specific innovation initiatives to position the organization for the future. Collaborate with Team Lead and global subject matter experts to meet the needs of partners across Baxter’s Global Business Units. Demonstrate and practice quality culture and compliance is embedded in the team and lab. Build a professional network within the business unit, across units and outside of Baxter.
Essential Duties and Responsibilities:
The Research Associate III is responsible for contributing to all phases of Extractable & Leachable studies carried out IH and at CROs. This would include prepare study design, protocol for sample preparation, analysis and data interpretation. Independently or with support of department manager, author and contribute to the experimental protocols, process and interpret data, author technical reports. Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need. Ensure compliance in all research work, data collection and reporting activities. Guide and direct the lab work for junior scientists. Maintain current knowledge of relevant Quality Management System 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. Support the build out of the R&D- E&L laboratory. Develop and enhance technical capability through training and on job experience. Ensure laboratory is equipped with instrumentation that is qualified to appropriate standards, maintained in a functional state and aligns with the business needs. Key contributor during experimental study designs, execution and review/approval at IH & CROs study. Competent in interpreting complex analytical data and presenting in a form that is suitable for a wide-ranging audience Collaborate with a multidisciplinary team of subject matter experts to generate innovative solutions to complex problems through the use of multiple disciplines and technical principles. Create innovative products/processes/methods through novel combinations of expertise within the organization. Coach and mentor junior members working in analytical method development in chromatography, Mass spectrometry, and identification/quantification of impurities. Influence the regional external regulatory environment in the areas of Extractables & Leachables, Elemental Impurities, and Structure Elucidation. Author, review and verify technical reports, protocols and reports, Laboratory process/ SOPsQualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Following knowledge, skills, and/or abilities required
N/A: Intern or Co-op
Hands on experience in handling the E&L research work. Well versed with theoretical knowledge, practical approaches, hands on instrumentation skills, troubleshooting and investigation of analytical research challenges, regulatory requirements for smooth conduct of E&L work. Must be well-versed in analytical chemistry, spectroscopy, and impurity quantitation and characterization, structure elucidation and possess knowledge in related disciplines. Must be able to critically analyze complex data. Experience in at least one of either LC-MS, HRMS, GC-MS or ICP-MS. Experienced in Analytical development and validation. Demonstrates ability to critically interpret chromatographic and complex spectroscopic data. Competent in operating and troubleshooting chromatographic and spectroscopic instrumentation. Demonstrate experience in directing and training junior scientists. Strong organizational & time management skills. Effective communication & fluency in English oral and written skills. Leadership of technical teams and project management experience is desirable. Technical, managerial, leadership, and strategic strengths are all important for this role. Well-versed to work in GMP and regulatory environment. Capable of analyzing and innovatively solving complex problems.Education and/or Experience:
Educational Qualification: Postgraduate/ Ph. D. in Pharmacy/ Chemistry or related field (M. Pharm./ M. Sc./ Ph. D.) Professional Experience: 8-15 years of relevant experience-
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