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Summary:
Support the Extractables and Leachables scientific excellence at GPRD, Ahmedabad. As a scientist on this team, use state-of-the-art technology (LC-MS, GC-MS, GC, UV, LC, IC, ICP-MS, ICP-OES) 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. Ensure 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 II is responsible for contributing to all phases of Extractable & Leachable studies carried out IH and at CROs. This would include study design as sample preparation, analysis, and data interpretation.
Independently or with support of sub department manager, author and contribute to the experimental protocols, process and interpret data, author technical reports in English.
Ensure technical output of the team is of the highest quality, scientifically sound and appropriately addresses the business need.
Ensure compliance in all research, data collection and reporting activities.
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.
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.
Contribute to the long-term scientific strategy of the department.
Track/monitor the regional external regulatory environment in the areas of Extractables & Leachables, Elemental Impurities, and Structure Elucidation. Write technical reports and documenting development work.
Qualifications:
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.
Strong organizational & time management skills.
Effective communication & fluency in English oral and written skills.
Technical, managerial, leadership, project management and strategic strengths are all important for this role.
Knowledge of GMP and regulatory guidelines.
Capable of analyzing and innovatively solving complex problems.
Education and/or Experience:
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.
Reasonable Accommodations
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