Research Scientist – Preclinical Biocompatibility and Toxicology (m/f/d)

Research Scientist – Preclinical Biocompatibility and Toxicology (m/f/d)

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies.

Join to apply for the Research Scientist – Preclinical Biocompatibility and Toxicology (m/f/d) role at Vantive.

What You'll Be Doing

• Designing, planning, and monitoring GLP toxicity studies and biocompatibility studies, including qualification of impurities, with supervision from the direct manager and senior team members
• Acting as sponsor representative and SME of biocompatibility to collaborate with external testing facilities to complete biocompatibility testing
• Participating as a preclinical/toxicology SME in core technical team meetings, providing inputs, and leading tasks to complete projects with effective collaboration and deliverables
• Participating in change control management and impact assessment; proposing options, working with stakeholders, and developing action plans for problem-solving and product/process improvement
• Maintaining current knowledge of regulatory requirements related to toxicology, product development, design, and safety
• Executing tasks within budget at the project level to ensure effective use of financial resources

What You'll Bring

• Degree in toxicology, pharmacology, chemistry, or related scientific field; with the following minimum experience in GLP/GMP environments: MS degree with 8+ years or PhD with 4+ years
• Proven experience with GLP nonclinical safety (toxicology) and toxicological risk assessment, with preference for Extractable & Leachable work
• Experience with safety and biocompatibility evaluation of medical devices and related regulatory guidance (USP, ISO 10993, EU MDR, etc.)
• Knowledge of ISO 10993-1, ISO and ICH Q3M7 guidelines
• European Registered Toxicologist (ERT) or Diplomate of the American Board of Toxicology (DABT) desired
• Experience in OECD and FDA Good Laboratory Practice
• Strong technical writing and oral presentation skills to clearly communicate study results and safety evaluations
• Ability to work independently and prioritize tasks to meet project schedules
• Ability to collaborate effectively in a global team and with external partners/CROs
• Excellent English language skills, spoken and written

Have we sparked your interest? If you thrive in a fast-paced environment and are excited about working in a learning and growth culture, we would love to talk to you. Apply directly on our Online System.

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Reasonable Accommodation

Vantive is committed to providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please click on the link here and share your request with your contact information.

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Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Other

Industries: Medical Equipment Manufacturing

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