🧾 Position Title:
Research Scientist II – Study Director
Req ID: JR-186887
Location: Round Lake, Illinois, United States
Job Category: Research & Development (R&D)
Work Type: Onsite (Flexible Workplace Policy Applies)
🧭 Overview
At Baxter, research is where new knowledge becomes life-saving innovation. Our R&D teams collaborate across disciplines — from scientists to engineers — to design and deliver solutions that save and sustain lives worldwide.
As a Research Scientist II – Study Director, you will play a key role in the Extractables and Leachables (E&L) program for medical devices and drug product packaging, ensuring that every product meets the highest standards of safety, quality, and regulatory compliance.
🎯 Position Summary
In this role, you will design, direct, and lead Extractables & Leachables (E&L) studies, ensuring compliance with global regulatory standards (e.g., ISO 10993-18, USP <1663>/<1664>).
You will collaborate with cross-functional experts, drive scientific excellence, and contribute to Baxter’s mission to provide patients worldwide with innovative and safe healthcare solutions.
⚙️ Key Responsibilities
1. Study Design & Direction
Lead and design comprehensive E&L studies for medical devices and drug product packaging.
Develop study protocols and reports that align with scientific rigor and regulatory standards.
Oversee method development, validation, and transfer activities in collaboration with analytical teams.
2. Cross-Functional Collaboration
Partner with experts in Chemistry, Biocompatibility, Regulatory Affairs, Manufacturing, Toxicology, and Program Management.
Coordinate E&L studies executed both internally and externally (contract laboratories).
Integrate cross-departmental insights to ensure the success of E&L programs.
3. Regulatory & Strategic Leadership
Engage with regulatory authorities during submissions, pre-submission meetings, and query resolution.
Formulate E&L strategies aligned with regulatory pathways, biocompatibility, and customer needs.
Ensure scientific alignment with ISO and USP standards throughout the study lifecycle.
4. Data Analysis & Risk Assessment
Review and interpret complex E&L analytical data to identify trends and material correlations.
Focus on structural identification of E&L compounds and collaborate with toxicologists on risk assessments.
Lead scientific investigations, applying critical reasoning and analytical expertise.
5. Quality & Compliance
Maintain a strong understanding of Quality System Regulations (QSR).
Ensure all E&L activities comply with Baxter’s quality policies and regulatory guidelines.
Author and review documentation to meet audit-ready standards.
🧠 Qualifications & Experience
Education:
Bachelor’s degree in a scientific discipline with 10+ years of experience, OR
Master’s degree with 5–7 years, OR
Ph.D. with 3+ years of relevant experience
Technical Expertise:
Proven experience in E&L studies, analytical method development, and validation.
Strong command of analytical chemistry techniques, including:
LC/MS, GC/MS, FID, UV, and ICP-MS
Solid understanding of chemical characterization for medical devices and drug packaging.
Knowledge of regulatory frameworks related to E&L, Container Closure Systems, and Medical Device standards.
Leadership & Collaboration:
Prior experience leading scientific teams or projects.
Excellent communication and cross-functional collaboration skills.
Demonstrated ability to mentor, coordinate, and influence across departments.
Preferred Experience:
People management or mentoring experience
Background in biocompatibility testing or toxicological risk assessment
💼 Compensation
Estimated Base Salary: $120,000 – $165,000 USD annually
Compensation may vary based on location, experience, and expertise.
Eligible for bonus and benefits as per Baxter’s pay philosophy.
🌟 U.S. Benefits (Excluding Puerto Rico)
Health & Well-Being:
Medical and Dental coverage (effective Day 1)
Life, Accident, and Disability Insurance
Business Travel Accident Coverage
Financial Benefits:
Employee Stock Purchase Plan (ESPP) – discounted company stock
401(k) Retirement Savings Plan with company match
Flexible Spending Accounts (FSA)
Work-Life Balance:
Paid Time Off (20–35 days, based on tenure)
Paid Holidays and Parental Leave
Family and Medical Leave
2 Paid Volunteer Days per year
Additional Perks:
Educational Assistance Programs
Employee Assistance Program (EAP)
Commuting & Childcare Benefits
Employee Discount Programs
🏢 Workplace Policy
Onsite role at Baxter’s Round Lake, Illinois facility
Flexible workplace policy ensures in-person collaboration and team connectivity
Subject to adjustment as per business needs and local laws
⚖️ Equal Employment Opportunity
Baxter is an Equal Opportunity Employer.
We evaluate applicants without regard to race, color, religion, sex, gender identity, national origin, age, sexual orientation, veteran, or disability status.
📜 Reference: Know Your Rights – Workplace Discrimination is Illegal.
♿ Reasonable Accommodation
If you require accommodation due to disability or medical condition, contact Baxter through the Reasonable Accommodation Portal for assistance during the application or interview process.
⚠️ Recruitment Fraud Notice
Baxter has reported cases of fraudulent job offers and impersonation.
Baxter will never request payment or personal banking information during hiring.
To confirm authenticity, visit Baxter’s Recruitment Fraud Notice page.
📍 Work Address
Baxter International Inc.
25212 W Illinois Route 120, RL/WG3
Round Lake, IL 60073
United States of America
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