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 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. Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met. Can effectively communicate with internal and external stakeholders. Excellent attention to detail. Good oral and written communication in English is required. Knowledge of French is highly desirable. Software knowledge of Siemens Teamcenter Unified, Microsoft Office, Trackwise, and Documentum based systems, recommended.

Education and/or Experience:

Bachelor's degree in a scientific discipline with 15 years of relevant experience.

MS with at least 10-year experience, or PhD with at least 3-4 years of relevant experienced required.

Required lab experience includes research in GLP/GMP environment, leadership of technical teams, and project/budget management.

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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