Study Director - Extractables & Leachables (e&l)

BAXTER HEALTHCARE PTY AUS

Braine-l'Alleud, Belgium
Not specified (assumed to be hybrid).
Extractables & leachables study leadership
Analytical method development and validation
Lc/ms, gc/ms, icp-ms technical expertise
Baxter Healthcare is seeking a Study Director specializing in Extractables & Leachables (E&L) to lead studies supporting medical devices and drug packaging in Braine-l'Alleud, Belgium. The ideal candidate will have extensive experience in E&L studies, regulatory knowledge, and strong analytical skills to contribute to patient safety and product quality

Job Summary

  • This role leads high-impact E&L studies supporting medical devices and drug product packaging used around the world to advance patient safety.
  • The successful candidate will develop robust E&L strategies that balance regulatory compliance, scientific rigor, and innovative product development.
  • Baxter offers an environment where you can collaborate with leading scientists, influence regulatory strategy, and shape the future of E&L science globally.

Matching Summary

Match Score: 85

Baxter Healthcare is seeking a Study Director specializing in Extractables & Leachables (E&L) to lead studies supporting medical devices and drug packaging in Braine-l'Alleud, Belgium. The ideal candidate will have extensive experience in E&L studies, regulatory knowledge, and strong analytical skills to contribute to patient safety and product quality.

Skills & Requirements

Must-have

  • Extractables & Leachables study leadership
  • Analytical method development and validation
  • LC/MS, GC/MS, ICP-MS technical expertise
  • ISO 10993-18 and USP <1663> knowledge
  • Toxicological risk assessment collaboration

Nice-to-have

  • Cross-functional multicultural team experience
  • Regulatory submission interaction skills
  • Strong scientific judgment and critical thinking
  • Innovative product development mindset

Key Requirements

  • Bachelor's degree in Chemistry or Biochemistry with 10+ years experience
  • Master's degree with 5-7 years relevant experience
  • PhD with 3+ years relevant experience
  • Demonstrated experience in E&L studies for medical devices
  • Solid knowledge of analytical techniques including LC/MS and GC/MS

Work Rights

Not specified

Tailored Resume

Cover Letter