Research Scientist II- Study Director,

Baxter International Inc.; Round Lake (IL); On-site; USD 128,000 - 176,000; Full time

Benefits offered by this job

Health insurance

Dental coverage

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter International Inc. in Round Lake, IL is seeking a Research Scientist II to lead extractables and leachables studies across medical devices and pharmaceutical products.

You will design campaigns, oversee study execution, and collaborate across Regulatory, Toxicology, Quality, and External labs. Ideal candidates have 12+ years in analytical chemistry or related fields, with expertise in E&L methods and leadership experience.

Qualifications

• E&L experience and knowledge of how E&L data supports submissions.
• Strong technical leadership and people management experience.
• Experience with coordinating multi-lacational studies and external labs.

Responsibilities

• Design and execute E&L studies for medical devices, pharmaceuticals and combination products.
• Provide strategic direction, technical oversight, and resource planning for E&L programs.
• Collaborate with Analytical Sciences, Toxicology, Regulatory Affairs, Quality, Manufacturing, and external labs.
• Oversee multiple E&L projects ensuring regulatory alignment, quality, and timelines.
• Develop and implement departmental E&L strategies and improve processes.
• Review protocols, reports, and regulatory documentation for scientific quality.
• Build organizational expertise in E&L science and regulatory standards including ISO 10993-18 and USP guidelines.

Skills

Mass spectrometry

Analytical chemistry

Regulatory knowledge

Education

Bachelor's degree with 12+ years / MS with 10+ years / PhD with 8+ years in analytical chemistry, toxicology, materials science, pharmaceutical sciences, or related field

Tools

Regulatory submissions

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.

• 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.

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.

We understand compensation is an important factor as you consider the next step in your career. 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. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well‑being benefits include 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. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

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.

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.

Recruitment Fraud Notice

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