Research Scientist II- Study Director
$128k - $176kBaxter
Research Scientist II position leading extractables and leachables (E&L) studies for medical devices and pharmaceutical products. The role involves designing regulatory-compliant studies, providing technical oversight across internal and external laboratories, and collaborating with cross-functional teams to support product development and submissions.
Responsibilities
- Design and execute E&L studies supporting medical devices, pharmaceuticals, and combination products
- Lead and coordinate E&L studies internally and with external laboratories with minimal oversight
- Provide technical oversight of multiple projects across product portfolio for consistency and regulatory alignment
- Review and approve protocols, reports, and regulatory documentation for scientific quality and defensibility
- Partner with cross-functional teams including Regulatory Affairs, Toxicology, and Quality on product development
Requirements
- Experience with E&L programs and analytical techniques, particularly mass spectrometry
- Bachelor's degree with 12+ years relevant experience, or MS with 10+, or PhD with 8+ years
- Background in analytical chemistry, toxicology, materials science, or pharmaceutical sciences
- Demonstrated technical leadership and people management experience
- Project management skills with ability to oversee multiple budgets and competing priorities
- Knowledge of regulatory standards including ISO 10993-18, USP <1663> , USP <1664>
Compensation: $128,000-$176,000 base
Vacancy posted 1 day ago
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