Research Associate II-E&L

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.

Extractables and Leachables Subject Matter Experts (SMEs) within the New Product Development (NPD) organization take ownership of the E&L strategy for a diverse product portfolio within the Pharmaceuticals Global Business Unit (GBU), interacting with numerous global cross-functional internal partners (Regulatory Affairs, Pre-Clinical Toxicologists, Device Engineers, Formulation Scientists & Quality) as projects progress from concept to launch and on-market support.

We now have a vacancy for an analytical scientist with proven expertise in chromatographic and mass spectroscopic techniques, applied within a highly regulated environment. The successful candidate will be recognized for their strong analytical expertise and awareness of E&L, taking on the role of an Extractables/Leachables Subject Matter Expert (SME) within the Pharma E&L team. In this role, the successful candidate will have responsibility for the oversight of all project related activity, as a team subject matter expert, to develop, validate, execute/review and summarize the E&L data.  The data generated plays a pivotal role in demonstrating the safety of the materials used to manufacture, package and deliver drug products within the Pharma portfolio.

Essential Duties:

• Applies practical and theoretical expertise in chromatographic (GC and LC), spectroscopic and mass spectrometry techniques to develop and execute non-routine experimental protocols.
• Competent    in    operating    and     troubleshooting chromatographic          and spectroscopic instrumentation.
• Authors and reviews a variety of technical data, reports, protocols, and regulatory dossiers and investigations for in-house and CROs studies.
• Execution of a diverse range of projects of high complexity.
• Maintain current knowledge of relevant Quality System, ability to design the investigation & write the investigation.
• Authors the Investigation Interfaces with internal partners to interpret complex analytical data; including quantitation, structural elucidation and toxicological assessment.
•  Maintain and focus on continuous improvement. Support team members and guide them in challenges.

Reasonable Accommodations
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