Study Director - Extractables & Leachables (E&L)

Drive Scientific Excellence in Patient Safety

Are you ready to make a meaningful impact in the field of Extractables and Leachables (E&L)?
At Baxter, we are committed to advancing patient safety through rigorous science and innovation. We are seeking an experienced Study Director – E&L to lead high‑impact studies supporting medical devices and drug product packaging used around the world.

Based in Braine‑l’Alleud, this role offers the opportunity to collaborate with leading scientists, influence regulatory strategy, and shape the future of E&L science in a dynamic, global environment.

Your Role

As a Study Director, you will lead the design, execution, and scientific oversight of E&L studies, ensuring alignment with global regulatory and industry standards such as ISO 10993‑18 and USP <1663> / <1664>.
You will develop robust E&L strategies that balance regulatory compliance, scientific rigor, and innovative product development, while acting as a key scientific interface across multiple functions.

What You Will Do

Study Design & Scientific Leadership

• Design, direct, and oversee extractables and leachables studies for medical devices and drug product packaging.

• Author and review study protocols, reports, and technical documentation, incorporating input from subject matter experts.

• Lead method development, validation, and transfer activities in collaboration with internal teams and external laboratories.

Strategic E&L Development

• Develop E&L strategies aligned with regulatory pathways, biocompatibility requirements, and customer expectations.

• Ensure scientific justification of study designs and results to support innovative and compliant products.

Data Interpretation & Risk Assessment

• Review and interpret E&L data, identifying trends and correlations with materials of construction.

• Drive the structural identification of extractables and leachables.

• Collaborate closely with Biocompatibility and Toxicology teams on toxicological risk assessments.

Cross‑Functional & Regulatory Engagement

• Work cross‑functionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners.

• Participate in regulatory interactions, including submissions, pre‑submission meetings, and responses to authority questions.

• Lead or support scientific investigations related to E&L findings.

Quality & Compliance

• Maintain a strong understanding of Quality System Regulations.

• Ensure compliance across study execution, data integrity, and reporting.

What You Bring

Education & Experience

• 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.

Technical Expertise

• 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.

Regulatory Knowledge

• Familiarity with global E&L regulatory expectations, particularly for medical devices and drug product packaging.

Professional Skills

• 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.

Why Join Baxter?

• Contribute directly to patient safety and product quality worldwide.

• Lead scientifically complex, high‑visibility studies with global impact.

• Work alongside recognized experts in analytical chemistry and biocompatibility.

• Thrive in an environment that values innovation, collaboration, and scientific integrity.