E&L Research Scientist II — Strategic Study Leader

Baxter International; Round Lake (IL); Hybrid; USD 128,000 - 176,000; Full time

Benefits offered by this job

Medical and dental coverage

401(k) Retirement Savings Plan

Employee Stock Purchase Plan (ESPP)

Paid time off 20 to 35 days

Job summary

Baxter is seeking a Research Scientist II to lead extractables and leachables (E&L) studies in Round Lake, IL. You will guide study design, provide technical leadership, and partner across Regulatory, Toxicology, and QA to ensure regulatory-compliant programs.

The role emphasizes strategic development, governance, and collaboration with internal teams and external labs to drive lifecycle management and innovation.

Qualifications

• Experience with extractables and leachables (E&L) programs and data usage for submissions.
• Proven ability to balance technical, regulatory, and business objectives.
• Experience managing multiple projects, budgets, and resources.
• Prior people management is highly desirable.

Responsibilities

• Design and execute E&L studies supporting medical devices, pharmaceuticals, and combos.
• Provide strategic direction, technical oversight, and resource planning.
• Coordinate with Analytical Sciences, Toxicology, Regulatory Affairs, and external labs.
• Oversee multiple E&L projects across the product portfolio and timelines.
• Develop departmental E&L strategies aligned with regs and business needs.
• Review protocols, reports, and regulatory documents for quality and defensibility.
• Build organizational expertise in E&L science and regulatory standards.

Skills

E&L program experience

Strategic thinking

Project management

Leadership

Education

Bachelor's +12+ yrs / MS +10 / PhD +8 in analytical sciences

Tools

Mass spectrometry

Analytical characterization methods

Job description

Baxter is seeking a Research Scientist II to lead extractables and leachables (E&L) studies in Round Lake, IL. You will guide study design, provide technical leadership, and partner across Regulatory, Toxicology, and QA to ensure regulatory-compliant programs.

The role emphasizes strategic development, governance, and collaboration with internal teams and external labs to drive lifecycle management and innovation.