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. Your Role: The Research Scientist I of Preclinical (Toxicology and biocompatibility) will support a portfolio of drug, medical device, drug packaging system, and/or combination product development and global registration. This individual will apply expertise in toxicology, biocompatibility, and related scientific knowledge for supporting and executing non-clinical safety / efficacy, toxicology risk assessment and/or biocompatibility strategies to assure product (patient) safety and efficacy through the application of current 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 and Toxicology assessment and will be part of a global team responsible 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. Toxicological risk assessment of chemicals used/encountered in manufacturing Participate and contribute in core technical team meetings as SME and provide inputs and lead task to be executed for completion of projects. Maintain current knowledge of relevant regulatory requirements related to toxicology, product development, design and safety 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, leachable, extractables, residual solvents and excipients) for regulatory submissions. 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 Utilize Lhasa Derek and Sarah Nexus software to assess toxicological endpoints. Execute tasks within budget at the project level to ensure the best utilization of financial resources. What You Will Bring: Relevant knowledge of 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. Shown technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions. Ability to work independently and prioritize assignments to meet project schedules. Can effectively collaborate in a global team, including ability to work with individuals of diverse scientific and cultural backgrounds across multiple business units as well as with external partners/CROs. What You Need: Degree in toxicology, pharmacology, chemistry or other related scientific field, with the following minimum previous experience working in the pharmaceutical/medical device industry in GLP/ MP environments: MS degree with 8+ years of relevant experience PhD with 4+ years of relevant experience Proven experience with the conduct and execution of GLP nonclinical safety (toxicology) and toxicological risk assessment on Extractable & Leachable is highly preferred. Experience with safety and biocompatibility evaluation of medical devices and related regulatory guidance (USP, ISOA 10993, EU MDR, etc). 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 $104,000 to $143,000 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 on upon location, skills and expertise, experience, and other relevant factors. 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. Join us as we revolutionize the treatment landscape and help improve patient lives worldwide. Baxter plans to spin off our $5B Kidney Care segment into an independent, publicly traded company. The new standalone entity will leverage 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. With its own investment priorities and enhanced management focus, the company will be better positioned to pursue growth opportunities and invest in innovation. We will build on our leadership in the kidney care space, fueled by our steadfast focus on innovation, our passion for patients and their families and our expertise in operational excellence. This is where you can make an impact. 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 here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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 . 121077 Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter 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. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy