Research Scientist II- Study Director

What You’ll Be Doing

As a Research Scientist II you will be responsible for designing and executing E&L studies supporting medical devices, pharmaceutical products, and combination products. You will provide strategic direction, technical oversight, and resource planning while ensuring alignment with industry standards, regulatory requirements, and business objectives. Working across R&D, Regulatory Affairs, Toxicology, Quality, and external laboratories, you will drive the development of scientifically sound and regulatory-compliant E&L programs that support innovation and product lifecycle management.

• Innovative Study Design: Collaborate with subject matter experts (SMEs) to craft comprehensive E&L studies that adhere to rigorous scientific and regulatory standards.
• Scientific and Strategic Leadership: Provide technical leadership and oversight for E&L studies. Lead and coordinate E&L studies both internally and at external laboratories, ensuring high-quality execution with minimal oversight.
• Organizational Leadership: Partner with cross-functional stakeholders including Analytical Sciences, Toxicology, Biocompatibility, Regulatory Affairs, Quality, Manufacturing, and Program Management to align E&L priorities and support successful product development and regulatory submissions.
• Portfolio Oversight: Provide oversight of multiple E&L projects and studies across the product portfolio, ensuring consistency in scientific approaches, regulatory alignment, quality, timelines, and budget management.
• Strategic Development: Develop and implement departmental E&L strategies that align with business objectives, regulatory requirements, and product development needs. Identify opportunities to improve processes, capabilities, and operational efficiency.
• Technical Governance: Review and approve protocols, reports, study plans, technical assessments, and regulatory documentation prepared by Study Directors. Ensure scientific quality, consistency, and regulatory defensibility.
• Capability Development: Build and maintain organizational expertise in E&L science, analytical characterization, toxicological risk assessment, and applicable regulatory standards including ISO 10993-18, USP , USP , and related guidance documents.
• External Laboratory Management: Provide strategic oversight of external laboratory partnerships, including vendor selection, performance monitoring, study quality, and scientific alignment with Baxter expectations.

What You’ll Bring

• E&L Experience: Experience with E&L programs, relevant analytical techniques/methodologies; especially mass spectroscopy; and how E&L data is used to support product submissions is required.
• Strategic Thinking: Proven ability to balance technical, regulatory, business, and organizational objectives while making sound decisions in complex situations.
• Project and Resource Management: Experience managing multiple projects, budgets, resources, and competing priorities across a diverse portfolio of activities.
• Leadership Experience: Demonstrated experience leading technical teams and establishing study priorities in a scientific or regulated environment. Previous experience with people management is highly desirable.
• Bachelor's degree with 12+ years of relevant experience, MS with 10+ years, or PhD with 8+ years in analytical chemistry, toxicology, materials science, pharmaceutical sciences, or a related scientific discipline.
• Demonstrated technical leadership and prior people management experience are required.