Job Description

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

The Materials India team supports business needs to sustain products, develop new products, contribute to failure investigations, through scientific expertise in global compliance standards pertaining to drug products and medical devices, analytical chemistry, materials characterization and failure analysis of polymeric materials.


The candidate for this position will:

• provide technical expertise to the Materials team in Renal R&D.
• work with state-of-the-art technology to solve complex analytical problems.
• collaborate with global Subject Matter Experts (SME's) to meet the needs of partners across Baxter.


demonstrate and practice Quality culture and compliance in all activities.

Essential Duties and Responsibilities:

• Lead the testing capability of materials used in drug products and medical devices (disposable, packaging, and container closure materials and container systems) to demonstrate their compliance to applicable standards such as USP (United States Pharmacopoeia), EP (European Pharmacopoeia), ISO, MDR, etc.
• Lead and contribute to experimental study designs for the identification and analysis of hazardous impurities, execution and review/approval.
• Provide sound and thorough interpretations of complex analytical data and present those in a form that is suitable for a broad range of audience - e.g., from technical SME's, Quality, regulatory, pre-medical to senior functional leadership.
• Collaborate with a multidisciplinary team of subject matter experts to generate innovative solutions to complex problems using multiple disciplines and technical principles.
• Coach and mentor junior members working in analytical method development in analytical techniques such as chromatography, spectroscopy, Mass spectrometry, and identification/quantification of impurities.
• Develop and enhance technical capability through continuous learning.
• Identify opportunities for improvement of existing methods, technologies, and approaches.
• Author, review and verify technical data, protocols and reports.
• 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.
• Contribute to the long-term scientific strategy of the organization.

Qualifications :

• Must have extensive hands-on experience in analytical chemistry, chromatographic techniques (GC-FID, GC-MS, HPLC/UPLC), and spectroscopy (UV-Vis).
• Expertise in regulatory guidelines such as USP, EP, and knowledge of GMP are desirable.
• Excellent written and verbal communication skills in English
• Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.
• Ability to organize complex information and demonstrated attention to detail.
• Without assistance, make sound technical recommendations.
• Capable of critically analyzing complex data, and innovatively solving complex problems.
• Demonstrates inclusive attitude, collaborates with team members and cross-functional teams for project deliverables.
• Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Provides and accepts critical feedback from others in a constructive manner.
• Adapts to changes and has an agile mindset.
• Embraces diversity and inclusion, values differences

Education and/or Experience:

• Masters' degree (Analytical Chemistry/Polymer chemistry or Polymer Engineering/Materials Science/Pharmaceutical analysis) with minimum 9 years' relevant professional experience
• Demonstrated technical ownership of projects
Reasonable Accommodations



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