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Research Scientist II – Extractables & Leachables (E&L) Team Lead

baxter · Braine-l'Alleud

New
Senior 🇬🇧 English
Extractables & Leachables (E&L) ISO 10993-18 USP <1663> USP <1664> Toxicology Biocompatibility Mass spectrometry

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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Source : ats:workday

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Published 9 hours ago

Expires 1 month from now

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baxter

Braine-l'Alleud