Research Scientist II – Extractables

Il y a 1 heure

belgium belgium Zvh Temps plein
pThis is where your work makes a difference. At 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. 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 job-you will find purpose and pride. At Baxter, we are deeply connected by our mission to Save and Sustain Lives. Every day, our products and therapies help improve outcomes for millions of patients worldwide. We are looking for an experienced scientific leader to join our Infusion Technologies Platforms RD organization as Research Scientist II
- EL Team Lead. /ppThis is more than an EL role. It is a unique opportunity to lead a team of subject matter experts, influence global regulatory strategies, and shape how Extractables Leachables science supports one of the most diverse healthcare portfolios in the industry. Based in Braine-l'Alleud, Belgium, this position offers significant global visibility and the opportunity to collaborate with experts across RD, Toxicology, Regulatory Affairs, Quality, Manufacturing and external laboratory partners around the world. /ppIn this role, you will: /pulliLead and develop a team of EL Study Directors, fostering technical excellence, engagement and professional growth. /liliDrive the strategic direction of EL programs supporting medical devices, pharmaceutical products and combination products. /liliPartner with global cross-functional teams to ensure EL strategies support product development, lifecycle management and regulatory submissions. /liliServe as a recognized technical leader and trusted advisor on EL topics across the organization. /liliGuide complex scientific and regulatory decisions while balancing business objectives, risk management and compliance requirements. /liliReview and approve study designs, technical assessments, protocols and reports to ensure scientific rigor and regulatory defensibility. /liliBuild organizational capabilities in EL science, analytical characterization and toxicological risk assessment. /liliRepresent Baxter during regulatory interactions, audits, inspections and customer discussions related to EL activities. /liliDevelop strong partnerships with external laboratories and ensure delivery of high-quality scientific outcomes. /liliIdentify opportunities to improve processes, strengthen capabilities and enhance operational efficiency across the EL function. /li /ulpWhat success looks like Within your first year, you will: /pulliBecome a trusted technical leader for EL across the organization. /liliEmpower and develop a high-performing team of Study Directors. /liliEnsure critical EL deliverables are executed on time and with high scientific quality. /liliStrengthen collaboration across global stakeholder groups. /liliSupport successful regulatory submissions and regulatory interactions through strong EL leadership. /li /ulpWe are looking for people who have: /pulliProven leadership experience managing and developing technical or scientific teams. /liliStrong experience in Extractables Leachables (EL) programs and how EL data supports regulatory submissions. /liliThe ability to translate complex scientific findings into clear business and regulatory recommendations. /liliExperience influencing stakeholders across multiple functions and organizational levels. /liliStrong strategic thinking and decision-making skills in complex, highly regulated environments. /liliExperience managing multiple projects, priorities and resources simultaneously. /liliExcellent communication skills and the ability to proactively engage diverse stakeholder groups. /li /ulpPreferred Qualifications /pulliExperience with ISO , USP 1663, USP 1664 and related regulatory guidance. /liliExperience in medical devices, pharmaceuticals or combination products. /liliKnowledge of toxicology, biocompatibility, mass spectrometry or advanced data interpretation. /li /ulpWhy Baxter? /ppThis is where you can work on one of the most diverse EL portfolios in healthcare. You will have the opportunity to: /pulliInfluence global product development programs. /liliLead a highly visible scientific team. /liliWork across medical devices, pharmaceuticals and combination products. /liliCollaborate with world-class experts worldwide. /liliDevelop your career within a global healthcare leader. /liliMake a meaningful impact on products that help patients around the world. /li /ulpIf you are passionate about EL science, enjoy developing people, and want to