Research Associate Ii, R&d Charact
2 months ago
**This is where you save and sustain lives**
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
**Summary**:
**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
- 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**:
- Educational Qualification: Master’s in pharmacy / Chemistry or Ph.D. in chemistry related field
- Experience range (desirable): Between 8 -12 years.
**Reasonable Accommodations**
**Recruitment Fraud Notice**
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