BAXTER Hiring for Biocompatibility SME / Toxicologist (Remote) Job at Deerfield, IL Full Time

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.

#This is where you have a direct impact on patient safety

The Biocompatibility SME / Toxicologist will support a diverse portfolio of medical devices for global registrations. In this role you will apply a proven understanding of medical devices and device packaging toxicology requirements to support safety evaluations and preclinical regulatory submission content development. Other responsibilities include design biological risk assessments/strategies for evaluating medical devices, monitor testing and interpret the results for project teams.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it’s building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there’s a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you’ll be doing

• Develop testing strategies such as the biological evaluation plan to qualify medical devices according to global guidelines.
• Lead 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 in alignment with ISO 10993-1 Develop preclinical regulatory submission content for DMF files, USA FDA 510 K Submission, EU MDR and global submissions.
• Address potential inquiries related to safety assessments (biocompatibility / toxicology risk assessments) submitted to FDA, EU notified bodies or global ministries of health.
• Implement the use of ISO 10993 series, regional pharmacopeia, 21 CFR Part 58 Good Laboratory Practices for Non-Clinical Studies, and/or regulatory guidance documents to qualify Baxter products.
• Perform preclinical change control impact assessments and work with cross functional team members (engineering, extractables and leachables, regulatory, etc.) to determine a comprehensive testing strategy.
• Mentor junior team members and review test strategies.

What you’ll bring

• Bachelor’s degree in a scientific field with 15 years of relevant experience.
• MS with at least 10 years experience, or PhD with at least 3-4 years of relevant experienced required.
• Lab experience includes research in GLP/GMP environment, leadership of technical teams, and project management experience is desirable.
• Relevant technical knowledge in biocompatibility/toxicology and general understanding of material physical and chemical properties.
• Ability to understand and apply global regulatory guidelines including OECD, FDA GLP, ISO 10993 series, USP pharmacopeia and regional compendia.
• Experience in working in global cross-functional teams and study monitoring.
• Critical thinker with intellectual self-assurance and courage.
• Independent problem solver who can use a methodical approach to develop solutions and make recommendations.
• Ability to contribute to efforts beyond own scope of responsibilities to ensure project achievements are met.
• Optimally connect with internal and external partners.
• Good oral and written communication in English. Multilingual desired for communication with global teams highly desired but not required (i.e. Spanish, French, Italian, German). Excellent attention to detail.
• Software knowledge of Siemens Teamcenter Unified, Microsoft Office, Trackwise, and Documentum based systems, recommended.
• DABT or eligible highly desired.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $112,000 to $216,000 and also includes an annual incentive bonus and equity target. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

#LI-BB1

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law – Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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