Biocompatibility & Toxicology Scientist

Overview 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 do 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 and cultural backgrounds across multiple business units and with external partners/CROs. Education and/or Experience Degree in toxicology, pharmacology, chemistry, or a related scientific field, with the following minimum experience in the pharmaceutical and/or medical device industry within GLP/GMP environments: M.S. degree with 8+ years of relevant experience or a Ph.D. with 4+ years of relevant experience Proven experience conducting GLP nonclinical safety (toxicology) studies and performing toxicological risk assessments for extractables and leachables is strongly preferred. Experience with safety and biocompatibility evaluations for medical devices and related regulatory guidance (e.g., USP, ISO 10993, EU MDR). This is a live role with flexible workplace policy including a minimum of 3 days onsite per week to support in-person collaboration in pursuit of our mission. Compensation and Benefits We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees. The estimated base salary for this position is $128,000 to $160,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. US Benefits at Vantive This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (“Aon PEP”), Vantive’s 401(k) retirement savings plan. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. For additional information regarding Vantive’s US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive Equal Employment Opportunity Vantive is an equal opportunity employer. Vantive 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. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodation Vantive 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. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive 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. #J-18808-Ljbffr Vantive