Research Scientist II- Study Director

Zvh; United States; On-site; USD 128,000 - 176,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter is seeking a Research Scientist II in Round Lake, Illinois to lead extractables and leachables (E&L) studies. You will design experiments across medical devices, pharmaceuticals, and combination products, providing strategic direction and regulatory-aligned oversight.

Collaborate across Regulatory Affairs, Toxicology, Quality, and external labs, ensuring high-quality, compliant programs. An emphasis on leadership and project management is required.

Qualifications

• Experience with E&L programs and analytical techniques; MS knowledge.
• Ability to balance technical, regulatory, business objectives.
• Experience managing multiple projects, budgets, and priorities.
• Leadership of technical teams in a regulated environment.

Responsibilities

• Design and execute E&L studies for medical devices, pharma, and combo products.
• Provide strategic direction, oversight, and resource planning.
• Lead E&L studies internally and at external labs with high quality execution.

Skills

EL&L experience

Strategic thinking

Project & resource management

Leadership experience

Education

Bachelor's degree + 12+ yrs

MS +10 yrs

PhD +8 yrs

Tools

Mass spectrometry

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Your role at Baxter

Are you ready to make a significant impact in the field of materials characterization? Baxter's Infusion Technology and Platforms R&D is seeking a dynamic and innovative Research Scientist II to spearhead cutting‑edge extractables and leachables (E&L) studies. This role, based in Round Lake, Illinois, offers the opportunity to collaborate with top‑tier scientists and drive innovative E&L studies in a fast‑paced environment.

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.

• Collaborate with subject material experts (SMEs) to craft comprehensive E&L studies that adhere to rigorous scientific and regulatory standards.
• 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.
• 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.
• 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.
• 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.
• Review and approve protocols, reports, study plans, technical assessments, and regulatory documentation prepared by Study Directors.
• Ensure scientific quality, consistency, and regulatory defensibility.
• Build and maintain organizational expertise in E&L science, analytical characterization, toxicological risk assessment, and applicable regulatory standards including ISO 10993-18, USP <1663>, USP <1664>, and related guidance documents.
• 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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in‑person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $128,000 to $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters.

• Medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time‑off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
• Join us and enjoy the competitive compensation and benefits we offer to our employees.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations: Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.