Senior Research Scientist – Toxicologist
Job Category: Research & Development / Toxicology / Medical Devices
Reference ID: JR-196647
Company: Baxter International Inc.
Location: Round Lake, Illinois, United States
Additional Locations: Milwaukee, Wisconsin; Chicago, Illinois
Employment Type: Full-Time
Work Authorization: U.S. work authorization required (no visa sponsorship available)
About the Employer
Baxter International Inc. is a global healthcare leader committed to advancing patient care through innovative medical devices, pharmaceuticals, and biotechnology solutions. With operations in more than 100 countries, Baxter’s mission to save and sustain lives drives its research, manufacturing, and commercialization strategies worldwide.
The organization fosters a culture of scientific excellence, cross-functional collaboration, regulatory integrity, and continuous innovation across its global Research & Development teams.
Position Overview
Baxter is seeking a highly experienced Senior Research Scientist – Toxicologist to lead non-clinical safety and toxicology strategies supporting medical device and pharmaceutical packaging development. This role is central to ensuring regulatory compliance, biological safety, and patient protection throughout the product lifecycle.
The successful candidate will define and execute toxicological risk assessments, biological evaluations, and non-clinical testing strategies in accordance with ISO 10993 standards, U.S. Pharmacopeia requirements, and global health authority expectations.
This is a senior-level role requiring deep technical expertise, regulatory engagement experience, and demonstrated leadership in GLP and R&D environments.
Key Responsibilities
1. Toxicology Strategy & Regulatory Compliance
Lead development of non-clinical safety and efficacy strategies for new product development (NPD), sustainment programs, and manufacturing improvement initiatives.
Author toxicological risk assessments, biological evaluation reports, and non-clinical testing plans aligned with ISO 10993 and global regulatory standards.
Ensure compliance with Good Laboratory Practices (GLP) and international regulatory frameworks.
2. Scientific Leadership
Serve as the primary Pre-Clinical Toxicology subject matter expert for assigned business segments.
Provide strategic and technical guidance to cross-functional project teams.
Evaluate scientific data, identify compliance gaps, and implement risk mitigation solutions.
3. Cross-Functional Collaboration
Partner with R&D, Regulatory Affairs, Clinical Affairs, Quality, Manufacturing, Environmental Health & Safety, and Medical Affairs.
Support regulatory submissions and respond to inquiries from health authorities and notified bodies.
Participate in standards committees and scientific forums to help shape emerging regulatory policies.
4. Project & Stakeholder Management
Manage multiple complex toxicology programs concurrently.
Prioritize deliverables to align with organizational objectives and commercialization timelines.
Present scientific findings to senior leadership and external stakeholders.
Required Experience & Qualifications
Education
PhD with minimum 4+ years of relevant experience in toxicology, pre-clinical sciences, or regulatory toxicology
OR
MS with minimum 10+ years of relevant experience
OR
BS with minimum 12+ years of relevant experience
Professional Experience
Experience in medical device toxicology strongly preferred.
Proven background in GLP-compliant environments and regulated R&D settings.
Hands-on experience developing toxicological risk assessments under ISO 10993 standards.
Direct interaction with regulatory bodies such as the U.S. FDA and EU notified bodies.
Demonstrated contribution to peer-reviewed scientific publications and conference presentations.
Experience supporting pharmaceutical packaging safety assessments is an advantage.
Technical Expertise
Strong understanding of biological evaluation of medical devices.
Expertise in extractables and leachables assessments.
Risk-based toxicological evaluation methodologies.
Regulatory submission support and response management.
Core Competencies
Advanced scientific problem-solving
Strategic decision-making under regulatory ambiguity
Cross-functional collaboration and influence
Strong written and verbal scientific communication
Innovation-driven mindset
Results-oriented project execution
Compensation & Benefits
Estimated Base Salary: USD $144,000 – $198,000 annually (location and experience dependent)
Medical and dental coverage from day one
401(k) with company matching
Employee Stock Purchase Plan (ESPP)
Paid time off (20–35 days based on tenure)
Paid parental leave
Educational assistance programs
Employee Assistance Program (EAP)
Flexible workplace policy (minimum onsite requirements apply)
Equal Opportunity Statement
Baxter International Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or other legally protected characteristics.
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