Biocompatibility & Toxicology Scientist

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. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. **Your Role** The Research Scientist I of Preclinical (Toxicology and Biocompatibility) supports a portfolio of drug, medical device, drug–device combination, and/or drug packaging system development programs and global registrations. The role applies expertise in toxicology, biocompatibility, and related scientific disciplines to develop and execute nonclinical safety/efficacy strategies, toxicology risk assessments, and/or biocompatibility plans to help assure product (patient) safety and effectiveness. This position contributes to new product development (NPD), sustaining product organization (SPO), and marginal improvement projects (MIP), and supports associated product development lifecycle management (PDLM) processes and initiatives. The role reports to the Associate Director, Preclinical and Toxicology and is part of a global team responsible for drugs and devices supporting Peritoneal Dialysis, Hemodialysis, and Acute Therapies (approximately \$5B product portfolio with global reach in more than 100 countries). **What you’ll be doing:** - Author complex study reports and toxicology risk assessments; review and/or concur on toxicology assessment reports as a subject matter expert (SME) in accordance with ICH guidelines and ISO 10993-17. - Conduct toxicological risk assessments for chemicals used and/or encountered in manufacturing. - Participate in core technical team meetings as an SME; provide input and lead assigned tasks to support timely project execution. - Maintain current knowledge of applicable regulatory requirements related to biocompatibility, toxicology, product development, design, and safety. - Serve as the preclinical/toxicology representative on project teams. Design, plan, and monitor GLP toxicity and biocompatibility studies, and develop risk/safety assessments (including assessment and qualification of impurities, contaminations, leachables, extractables, residual solvents, and excipients) for regulatory submissions. Support change control, including impact assessments, and perform and/or support GLP audits and inspections of studies, sites, and facilities (including CROs). - Prepare and/or review nonclinical eCTD and PBRER sections. - Use Lhasa Derek and Sarah Nexus software to assess toxicological endpoints. - Manage assigned project tasks within budget to ensure effective use of financial resources. **What you’ll bring:** - Demonstrated knowledge of ISO 10993-1, ISO 10993-17, and ISO 10993-18. - Experience authoring Toxicological Risk Assessments and deriving Tolerable Intake values, Margins of Safety, and Analytical Evaluation Thresholds. - Strong technical writing and oral presentation skills to communicate study results, safety evaluations, and toxicology assessment conclusions clearly and effectively. - Ability to work independently and prioritize assignments to meet project timelines. - Demonstrated ability to collaborate effectively within a global team, including partnering with individuals from diverse scientific a…