Research Scientist II of Preclinical (Toxicology and biocompatibility)

Vantive: A New Company Built On Our Legacy Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 dont settle for the mediocre. Each of us are driven to help improve patients lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions. The Research Scientist II of Preclinical (Toxicology and Biocompatibility) will support a portfolio of drug, drug packaging system, medical device, and/or combination product development and global registration. This individual will apply expertise in toxicology, biocompatibility, and related scientific knowledge, to provide technical leadership for non-clinical safety / efficacy, toxicology risk assessment and/or biocompatibility strategies to assure product (patient) safety and efficacy through the application of innovative pre-clinical science, non-clinical safety assessment, and toxicological principles and methods to enable and support new product development (NPD), sustaining product organization (SPO) and margin improvement projects (MIP) and associated product development lifecycle management (PDLM) processes and initiatives. The role will report to Associate Director of Preclinical Biocompatibility and Toxicology and will be responsible for drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries). What you will be doing: Author complicated studies/ toxicology risk assessment reports and review or concur toxicology assessment reports as subject matter expert (SME) in accordance with ICH and ISO10993-17. Maintain current knowledge of relevant regulatory requirements related to toxicology, product development, design and safety and act as a technical expert in these areas as it pertains to product development and registration. Perform as preclinical/toxicology representative on project teams. Design, plan, monitor various GLP toxicity studies, biocompatibility studies, risk/safety assessment (risk assessment and qualification of impurities, leachables, extractables, residual solvents and excipients) for regulatory submissions. Recommend actions, path forward and decisions aligned with overall project objectives and timelines. Participate in change control management and impact assessment. Perform/support audits/inspection (GLP) of studies/sites/facilities (CROs). Prepare and/or review nonclinical eCTD and PBRER sections Use Lhasa Derek and Sarah Nexus software to assess toxicological endpoints. Qualifications: Relevant knowledge of ICH guidelines, ISO 10993-1, ISO 10993-17 and ISO 10993-18 required. Experience authoring Toxicological Risk Assessments and deriving Tolerable Intake values, Margin of Safety and Analytical Evaluation Thresholds. Demonstrated technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions. Demonstrated experience working with regulatory authorities for device and/or drug registrations in US markets (prefer experience with US and European authorities) Education and/or Experience: MS degree with minimum of 10 years experience OR PhD with 6 years of relevant experience Experience in conduct and execution of GLP nonclinical safety (toxicology) and toxicological risk assessment on Extractable & Leachable is highly preferred. Experience with safety and biocompatibility evaluation f medical devices and related regulatory guidance (ICH, USP, ISO 10993, EU MDR, etc). Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. 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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $144,000-198,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based upon 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. #LI-BG1 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. 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. 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