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Research Scientist Toxicology & Biocompatibility

Req #: JR - 075215 Location Braine-l'Alleud, Wallonia, Belgium Job Category: Research and Development Date Posted: 07/12/2022

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

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Research Scientist Toxicology & Biocompatibility

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary:

Toxicologist/biocompatibility subject matter expert supporting a diverse portfolio of clinical nutrition and solution/device combination products for global registrations.  Apply a solid understanding of drug and device biocompatibility and toxicology requirements to support preclinical safety evaluations and regulatory submission content development. Design toxicology studies for evaluating new drug products and biological risk assessments. Design strategies for evaluating medical devices, drug products, and packaging.  Monitor testing and interpret the results for project teams. Engage with global internal and external stakeholders to drive projects forward.

Essential Duties and Responsibilities:

  • Develop testing strategies for new drug products for IND and NDA submissions. Apply ICH guidelines (i.e. ICH-M3, ICH-S1 trough ICH-S11) to propose case-specific testing plan and engage with regulatory agencies (e.g. FDA, EU notified bodies) to secure acceptability of the plan. Apply ICHQ3A through ICHQ3D and ICH-M7 to support safety of impurities in drug substances and drug products. Develop biological safety evaluation strategy to qualify medical devices in alignment with ISO 10993-1.

  • Implement the use of applicable guidelines, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices for Non-Clinical Studies, and/or regulatory guidance documents to qualify Baxter products. Develop preclinical regulatory submission content for CTD, DMF files, USA FDA 510 K Submission, EU MDR and global submissions. Address potential inquiries related to safety assessments (toxicology risk assessments/biocompatibility) submitted to FDA, EU notified bodies or global ministries of health.

  • Perform impact assessments for changes to sustaining products and work with cross functional team members (manufacturing, extractables and leachables, regulatory, medical affairs etc.) to determine a comprehensive testing strategy. Mentor junior team members and review biological safety evaluation strategies. Oversee shipment of products to external contract laboratories.

  • Manage projects and coordinate safety testing for Baxter’s product portfolio. Review literature and identify relevant articles to support product development and registration.  Interpret data and develop justifications to address safety.

Qualifications:

DABT, ERT or eligible highly desired.

The position requires relevant technical knowledge in toxicology/biocompatibility and general understanding of drug development strategies.  

Understanding of material physical and chemical properties is highly desirable. Ability to understand and apply global regulatory guidelines including ICH, OECD, FDA GLP, ISO 10993 series, US pharmacopeia and regional

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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075215

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Reagan

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Karthik

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

Amitha

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Reagan

Meet Reagan, Senior Research Scientist in the United States

"For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference."

Karthik

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

"I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world."

Amitha

Meet Amitha, Research Associate in India

"Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter."

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