This is where your work makes a difference.
At Baxter, we believe every personâregardless of who they are or where they are fromâdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a jobâyou will find purpose and pride.Â
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 â E&L to lead highâimpact studies supporting medical devices and drug product packaging used around the world.
Based in BraineâlâAlleud, 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 10993â18 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.
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.
CrossâFunctional & Regulatory Engagement
Work crossâfunctionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners.
Participate in regulatory interactions, including submissions, preâsubmission 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.
Education & Experience
Bachelorâs degree in a scientific discipline (ideally Chemistry or Biochemistry) with 10+ years of relevant experience, or
Masterâs degree with 5â7 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 ICPâMS.
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 crossâfunctional, multicultural teams.
Contribute directly to patient safety and product quality worldwide.
Lead scientifically complex, highâvisibility studies with global impact.
Work alongside recognized experts in analytical chemistry and biocompatibility.
Thrive in an environment that values innovation, collaboration, and scientific integrity.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
baxter