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 supporting medical devices, pharmaceutical products, and combination products. Based in Round Lake, Illinois, the role involves designing and executing studies and providing strategic direction, technical oversight, and resource planning in alignment with industry standards, regulatory requirements, and business objectives. The position works across R&D, Regulatory Affairs, Toxicology, Quality, and external laboratories to develop scientifically sound, regulatory-compliant E&L programs that support innovation, product development, regulatory submissions, and product lifecycle management. The role also oversees multiple projects across the portfolio, guides departmental E&L strategy and capabilities, and manages external laboratory partnerships. Baxter describes its workplace policy as flexible, with a required minimum number of days onsite each week. The estimated base salary is $128,000 to $176,000 annually, and the position may also be eligible for discretionary bonuses. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is unavailable at this time.
Requirements
- Experience with E&L programs and relevant analytical techniques or methodologies, especially mass spectroscopy, is required.
- Understanding 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.
- Technical leadership and prior people management experience are required.
- Bachelor’s degree with 12 or more years of relevant experience, a master’s degree with 10 or more years, or a Ph.D. 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 U.S.; Baxter is unable to sponsor or take over sponsorship of an employment visa.
Nice To Haves
- Previous experience with people management is highly desirable.
Responsibilities
- Collaborate with subject matter experts to design comprehensive E&L studies that meet scientific and regulatory standards.
- Provide technical leadership and oversight for E&L studies, coordinating work internally and at external laboratories with minimal oversight.
- Partner with Analytical Sciences, Toxicology, Biocompatibility, Regulatory Affairs, Quality, Manufacturing, and Program Management to align priorities and support product development and regulatory submissions.
- Oversee multiple E&L projects and studies across the product portfolio, ensuring consistency in scientific approaches, regulatory alignment, quality, timelines, and budgets.
- 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 with Baxter expectations.
- Manage multiple projects, budgets, resources, and competing priorities across a portfolio of activities.
- Lead technical teams and establish study priorities in a scientific or regulated environment.
Benefits
- Medical and dental coverage beginning on day one
- Basic life, accident, short-term disability, 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
- Potential eligibility 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
