Research Scientist II- Study Director
Core
Designing and executing extractables and leachables (E&L) studies for medical devices, pharmaceutical products, and combination products to support regulatory submissions and product lifecycle management.
Role type
Senior IC Research Scientist II (Study Director)
Builds
Regulatory-compliant E&L programs and study reports for medical device and pharmaceutical portfolios
Domain
Medical devices / Pharmaceuticals / Materials Characterization
Required skills
E&L program design and execution, mass spectroscopy, strategic leadership, project and resource management, technical governance, external laboratory management, regulatory standards knowledge (ISO 10993-18, USP <1663>, USP <1664>)
Preferred skills
People management experience, cross-functional stakeholder collaboration
Technologies
Mass spectroscopy, ISO 10993-18, USP <1663>, USP <1664>
Responsibilities
Design and execute E&L studies; provide technical leadership and oversight for internal and external studies; partner with cross-functional stakeholders to align E&L priorities; oversee multiple E&L projects for consistency and budget; develop departmental E&L strategies; review and approve protocols and reports from Study Directors; build organizational expertise in E&L science and toxicological risk assessment.
Seniority
Senior, hands-on IC with people management
