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Study Director - Extractables & Leachables (E&L)

https://www.baxter.com/ Logo

Baxter

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Location:
Belgium , Braine-l'Alleud

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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Job Description:

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

Job Responsibility:

  • Design, direct, and oversee extractables and leachables studies for medical devices and drug product packaging
  • Author and review study protocols, reports, and technical documentation
  • Lead method development, validation, and transfer activities
  • Develop E&L strategies aligned with regulatory pathways, biocompatibility requirements, and customer expectations
  • Ensure scientific justification of study designs and results
  • Review and interpret E&L data, identifying trends and correlations
  • Drive the structural identification of extractables and leachables
  • Collaborate closely with Biocompatibility and Toxicology teams on toxicological risk assessments
  • Work cross-functionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners
  • Participate in regulatory interactions
  • Lead or support scientific investigations related to E&L findings
  • Maintain a strong understanding of Quality System Regulations
  • Ensure compliance across study execution, data integrity, and reporting

Requirements:

  • Bachelor's degree in a scientific discipline (ideally Chemistry or Biochemistry) with 10+ years of relevant experience, or Master's degree with 5–7 years, or PhD with 3+ years of experience in a related field
  • Demonstrated experience in Extractables & Leachables studies
  • Strong background in analytical method development and validation
  • Solid knowledge of analytical techniques such as LC/MS/UV, GC/MS/FID, and ICP-MS
  • Experience with chemical characterization standards for medical devices and container closure systems
  • Familiarity with global E&L regulatory expectations, particularly for medical devices and drug product packaging
  • Strong scientific judgment and critical thinking
  • Ability to lead complex studies with autonomy and rigor
  • Excellent communication and collaboration skills
  • Comfortable working in cross-functional, multicultural teams
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Health & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
May 03, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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