Research Scientist II – Extractables & Leachables (E&L) Team Lead
baxter · Braine-l'Alleud
Job description
About the role
Baxter is looking for an experienced scientific leader to join its Infusion Technologies & Platforms R&D organization as Research Scientist II – E&L Team Lead, based in Braine-l'Alleud, Belgium. The role leads a team of E&L Study Directors, influences global regulatory strategies and shapes how Extractables & Leachables science supports a diverse portfolio of medical devices, pharmaceutical products and combination products.
Key responsibilities
- Lead and develop a team of E&L Study Directors, fostering technical excellence, engagement and professional growth.
- Drive the strategic direction of E&L programs and partner with global cross-functional teams so E&L strategies support product development, lifecycle management and regulatory submissions.
- Serve as a recognized technical leader and trusted advisor on E&L topics, guide complex scientific and regulatory decisions and balance business objectives, risk management and compliance.
- Review and approve study designs, technical assessments, protocols and reports.
- Build organizational capabilities in E&L science, analytical characterization and toxicological risk assessment.
- Represent Baxter in regulatory interactions, audits, inspections and customer discussions, and build partnerships with external laboratories.
- Identify opportunities to improve processes and strengthen capabilities across the E&L function.
Required profile
- Proven leadership experience managing and developing technical or scientific teams.
- Strong experience in E&L programs and how E&L data supports regulatory submissions.
- Ability to turn complex scientific findings into clear business and regulatory recommendations.
- Experience influencing stakeholders across functions and levels, and managing multiple projects and priorities.
- Excellent communication skills and proactive engagement with diverse stakeholders.
Preferred qualifications
- Experience with ISO 10993-18, USP <1663> and USP <1664> and related regulatory guidance.
- Experience in medical devices, pharmaceuticals or combination products.
- Knowledge of toxicology, biocompatibility, mass spectrometry or advanced data interpretation.
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Published 9 hours ago
Expires 1 month from now
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baxter
Braine-l'Alleud
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