Research Associate II, R&D Charact.
Research Associate II, R&D Charact.
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Job Description
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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 liveswhere your purpose accelerates our mission.
Summary:
Support the Extractables and Leachables scientific excellence of the Ahmedabad R&D. As a scientist on this team use stateoftheart technology (GCMS LCMS) 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 Baxters 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 wideranging 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 longterm 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 wellversed 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 LCMS HRMS GCMS or ICPMS.
- 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: Masters in pharmacy / Chemistry or Ph.D. in chemistry related field
- Experience range (desirable): Between 8 12 years.
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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Required Experience:
IC
Employment Type
Full-Time
