Research Scientist II – Extractables & Leachables (E&L) Team Lead
Core
Lead a team of E&L Study Directors and drive strategic E&L programs for medical devices, pharmaceuticals, and combination products to support regulatory submissions and product lifecycle management.
Role type
Senior IC E&L Team Lead (Strategy & People Management)
Builds
Global E&L strategies, regulatory submissions, and organizational capabilities in analytical characterization and toxicological risk assessment.
Domain
Healthcare (Medical Devices, Pharmaceuticals, Combination Products)
Required skills
Team leadership and development, E&L program management, regulatory strategy influence, cross-functional stakeholder management, complex scientific decision-making, project and resource management, technical review and approval of study designs/protocols/reports, external laboratory partnership management, process improvement.
Preferred skills
ISO 10993-18, USP <1663>, USP <1664> knowledge, toxicology, biocompatibility, mass spectrometry, advanced data interpretation.
Technologies
ISO 10993-18, USP <1663>, USP <1664>
Responsibilities
Lead and develop a team of E&L Study Directors; Drive strategic direction of E&L programs; Partner with global cross-functional teams on product development and regulatory submissions; Serve as a trusted technical advisor on E&L topics; Guide complex scientific and regulatory decisions; Review and approve study designs, protocols, and reports; Build organizational capabilities in E&L science; Represent Baxter in regulatory interactions and audits; Develop partnerships with external laboratories; Identify opportunities to improve E&L processes.
Seniority
Senior, hands-on IC with team leadership
