Research Scientist I - Extractables & Leachables Lead

Baxter; Round Lake Beach (IL); On-site; USD 104,000 - 143,000; Full time

Benefits offered by this job

Medical and dental coverage from day 1

401(k) with company matching

Employee Stock Purchase Plan (ESPP)

Educational assistance programs

Paid time off 20–35 days

Commuting benefits

Employee Discount Program

Employee Assistance Program (EAP)

Childcare benefits

Job summary

Baxter is recruiting a Research Scientist I - Extractables and Leachables in Round Lake, Illinois. You will lead analytical studies, develop and validate methods, and collaborate with cross-functional teams to drive compliant product development and data-driven decisions.

The role emphasizes analytical judgment, problem solving, and effective communication of complex data to diverse stakeholders within a regulated R&D chemistry lab environment.

Qualifications

• Bachelor's degree in Chemistry or a related scientific discipline with 5+ years of relevant experience, Master's degree with 3+ years, or PhD with applicable analytical chemistry experience.
• Hands-on expertise in analytical chemistry techniques, including wet chemistry, GC/MS, GC/FID, LC/MS, mass spectrometry, and related instrumental analysis.
• Proven experience with analytical method development, validation, and transfer in a regulated environment.

Responsibilities

• Lead extractables & leachables studies, including analytical method development, validation, transfer, and lifecycle support.
• Perform advanced chemical and impurity analyses using LC, GC, ICP, MS, and related sample preparation and wet chemistry techniques.
• Partner with Regulatory, Toxicology, Quality, Manufacturing, Project Management, and R&D teams to support product development and compliance objectives.
• Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results, applying strong scientific judgment and root cause analysis skills.
• Analyze, interpret, and communicate complex analytical data, translating findings into clear recommendations for both technical and non-technical stakeholders.
• Author and maintain analytical protocols, validation reports, SOPs, and technical documentation in compliance with cGxP and Quality System requirements.
• Serve as a subject matter expert on regulatory expectations, including USP, ICH, cGxP, and method validation requirements.
• Drive continuous improvement and operational excellence initiatives while mentoring colleagues and sharing technical expertise across the laboratory team.

Skills

GC/MS

GC/FID

LC/MS

Mass spectrometry

Analytical chemistry

Analytical method development

Regulatory understanding

Education

Bachelor's degree in Chemistry or related

Master's degree in Chemistry or related

PhD in Analytical Chemistry

Tools

MassHunter

Empower

Chromeleon

e-Noval

Job description

Baxter is recruiting a Research Scientist I - Extractables and Leachables in Round Lake, Illinois. You will lead analytical studies, develop and validate methods, and collaborate with cross-functional teams to drive compliant product development and data-driven decisions.

The role emphasizes analytical judgment, problem solving, and effective communication of complex data to diverse stakeholders within a regulated R&D chemistry lab environment.