PpAt Baxter, we believe every person—regardless of who they are or where they are from—deserves 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. /p pOur 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. /p pHere, you will find more than just a job—you will find purpose and pride. /p h3Drive Scientific Excellence in Patient Safety /h3 pAre you ready to make a meaningful impact in the field of Extractables and Leachables (EL)? At Baxter, we are committed to advancing patient safety through rigorous science and innovation. We are seeking an experienced Study Director – EL to lead high‑impact studies supporting medical devices and drug product packaging used around the world. /p pBased in Braine‑l’Alleud, this role offers the opportunity to collaborate with leading scientists, influence regulatory strategy, and shape the future of EL science in a dynamic, global environment. /p h3Your Role /h3 pAs a Study Director, you will lead the design, execution, and scientific oversight of EL studies, ensuring alignment with global regulatory and industry standards such as ISO 10993‑18 and USP 1663 / 1664. You will develop robust EL strategies that balance regulatory compliance, scientific rigor, and innovative product development, while acting as a key scientific interface across multiple functions. /p h3What You Will Do /h3 h3Study Design Scientific Leadership /h3 ul liDesign, direct, and oversee extractables and leachables studies for medical devices and drug product packaging. /li liAuthor and review study protocols, reports, and technical documentation, incorporating input from subject matter experts. /li liLead method development, validation, and transfer activities in collaboration with internal teams and external laboratories. /li /ul h3Strategic EL Development /h3 ul liDevelop EL strategies aligned with regulatory pathways, biocompatibility requirements, and customer expectations. /li liEnsure scientific justification of study designs and results to support innovative and compliant products. /li /ul h3Data Interpretation Risk Assessment /h3 ul liReview and interpret EL data, identifying trends and correlations with materials of construction. /li liDrive the structural identification of extractables and leachables. /li liCollaborate closely with Biocompatibility and Toxicology teams on toxicological risk assessments. /li /ul h3Cross‑Functional Regulatory Engagement /h3 ul liWork cross‑functionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners. /li liParticipate in regulatory interactions, including submissions, pre‑submission meetings, and responses to authority questions. /li liLead or support scientific investigations related to EL findings. /li /ul h3Quality Compliance /h3 ul liMaintain a strong understanding of Quality System Regulations. /li liEnsure compliance across study execution, data integrity, and reporting. /li /ul h3What You Bring /h3 h3Education Experience /h3 ul liBachelor’s degree in a scientific discipline (ideally Chemistry or Biochemistry) with 10+ years of relevant experience, or /li liMaster’s degree with 5–7 years, or /li liPhD with 3+ years of experience in a related field. /li /ul h3Technical Expertise /h3 ul liDemonstrated experience in Extractables Leachables studies. /li liStrong background in analytical method development and validation. /li liSolid knowledge of analytical techniques such as LC/MS/UV, GC/MS/FID, and ICP‑MS. /li liExperience with chemical characterization standards for medical devices and container closure systems. /li /ul h3Regulatory Knowledge /h3 ul liFamiliarity with global EL regulatory expectations, particularly for medical devices and drug product packaging. /li /ul h3Professional Skills /h3 ul liStrong scientific judgment and critical thinking. /li liAbility to lead complex studies with autonomy and rigor. /li liExcellent communication and collaboration skills. /li liComfortable working in cross‑functional, multicultural teams. /li /ul h3Why Join Baxter? /h3 ul liContribute directly to patient safety and product quality worldwide. /li liLead scientifically complex, high‑visibility studies with global impact. /li liWork alongside recognized experts in analytical chemistry and biocompatibility. /li liThrive in an environment that values innovation, collaboration, and scientific integrity. /li /ul h3Equal Employment Opportunity /h3 pBaxter 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. /p h3Reasonable Accommodations /h3 pBaxter 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. /p h3Recruitment Fraud Notice /h3 pBaxter 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. /p /p #J-18808-Ljbffr