Research Scientist II- Study Director
About The Position
Baxter’s Infusion Technology and Platforms R&D is seeking a Research Scientist II to lead extractables and leachables (E&L) studies in materials characterization. Based in Round Lake, Illinois, the role designs and executes E&L studies supporting medical devices, pharmaceutical products, and combination products. It provides strategic direction, technical oversight, and resource planning to ensure scientific and regulatory alignment with industry standards and business objectives. The position works across R&D, Regulatory Affairs, Toxicology, Quality, Manufacturing, Analytical Sciences, Biocompatibility, Program Management, and external laboratories. It leads internal and external studies, oversees multiple projects across the product portfolio, manages external laboratory partnerships, and contributes to product development, lifecycle management, and regulatory submissions. The role also develops departmental E&L strategies, reviews and approves technical and regulatory documentation, and builds organizational expertise in E&L science and related standards. Baxter’s flexible workplace policy requires a minimum number of onsite days per week. The position is based in Round Lake, Illinois. The estimated annual base salary is $128,000 to $176,000, and the role may be eligible for discretionary bonuses. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available.
Requirements
- Experience with E&L programs and relevant analytical techniques or methodologies, especially mass spectroscopy, and knowledge of how E&L data supports product submissions.
- Proven ability to balance technical, regulatory, business, and organizational objectives and make sound decisions in complex situations.
- Experience managing multiple projects, budgets, resources, and competing priorities across a diverse portfolio.
- Demonstrated experience leading technical teams and establishing study priorities in a scientific or regulated environment.
- Demonstrated technical leadership and prior people management experience.
- Bachelor’s degree with 12 or more years of relevant experience, master’s degree with 10 or more years, or PhD with 8 or more years in analytical chemistry, toxicology, materials science, pharmaceutical sciences, or a related scientific discipline.
- Authorization to work for any employer in the United States; visa sponsorship is unavailable.
Nice To Haves
- Previous experience with people management is described as highly desirable.
Responsibilities
- Design comprehensive E&L studies for medical devices, pharmaceutical products, and combination products in collaboration with subject matter experts.
- Provide technical leadership and oversight for E&L studies, coordinating work internally and at external laboratories.
- Partner with cross-functional stakeholders to align E&L priorities and support product development and regulatory submissions.
- Oversee multiple E&L projects and studies across the product portfolio, maintaining scientific consistency, regulatory alignment, quality, timelines, and budget management.
- Develop and implement departmental E&L strategies aligned with business objectives, regulatory requirements, and product development needs.
- Identify opportunities to improve processes, capabilities, and operational efficiency.
- Review and approve protocols, reports, study plans, technical assessments, and regulatory documentation prepared by Study Directors.
- Build and maintain organizational expertise in E&L science, analytical characterization, toxicological risk assessment, and applicable regulatory standards.
- Provide strategic oversight of external laboratory partnerships, including vendor selection, performance monitoring, study quality, and scientific alignment.
Benefits
- Medical and dental coverage starting on day one
- Basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan with employee contributions and company matching
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- Paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare benefits
- The position may be eligible for discretionary bonuses
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
