Analytical Scientist, Extractables & Leachables

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

Benefits offered by this job

Medical and dental coverage

401(k) plan with match

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter is seeking a Research Scientist I - Extractables and Leachables in Round Lake, IL to advance analytical science and support product development. You will lead studies, develop methods, and communicate findings with cross-functional teams.

The role emphasizes regulatory understanding (USP/ICH), cGxP compliance, and the ability to mentor colleagues while driving continuous improvement in an R&D chemistry lab setting.

Qualifications

• Bachelor's degree in Chemistry or related discipline with 5+ years of experience, Master's 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.
• Proven experience with analytical method development, validation, and transfer in a regulated environment.
• Strong understanding of ICH, USP and cGxP requirements with ability to apply regulatory expectations to lab activities.
• Proficiency with analytical software platforms such as MassHunter, Empower, Chromeleon, e-Noval, or similar data systems.
• Ability to design experiments, troubleshoot, analyze data, and draw scientifically sound conclusions.
• Strong attention to detail and track record of high-quality, compliant results.

Responsibilities

• Lead extractables & leachables studies including method development, validation, transfer, and lifecycle support.
• Perform advanced chemical and impurity analyses using LC, GC, ICP-MS, and related techniques.
• Collaborate with Regulatory, Toxicology, Quality, Manufacturing, PM, and R&D teams to support product development and compliance.
• Investigate OOS/OOT and atypical results with strong scientific judgment and root cause analysis.
• Interpret and communicate complex analytical data to both technical and non-technical stakeholders.
• Author and maintain analytical protocols, validation reports, SOPs, and regulatory documentation per cGxP and Quality System.
• Serve as SME on regulatory expectations (USP, ICH, cGxP, method validation).
• Drive continuous improvement and mentor colleagues across the lab.

Skills

GC/MS

LC/MS

Mass spectrometry

Analytical method development

Data analysis

Education

Bachelor's in Chemistry

Master's degree (preferred)

PhD (preferred)

Tools

MassHunter

Empower

Chromeleon

e-Noval

Job description

Baxter is seeking a Research Scientist I - Extractables and Leachables in Round Lake, IL to advance analytical science and support product development. You will lead studies, develop methods, and communicate findings with cross-functional teams.

The role emphasizes regulatory understanding (USP/ICH), cGxP compliance, and the ability to mentor colleagues while driving continuous improvement in an R&D chemistry lab setting.