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.Preclinical biocompatibility and toxicology SME (Research Associate III)In this role theResearcher of Preclinical (Toxicology and biocompatibility)will apply expertise in toxicology and medical device biocompatibility testing including development of toxicity study design and biocompatibility testing design for drug/drug packaging system/medical device development, monitoring the studies, and development of toxicological risk assessments.The successful candidate will have hands-on experience in hazard evaluation of chemicals used in manufacturing. You will participate in preparing reports for external regulatory bodies in accordance with ICH and ISO10993 to assure product (patient) safety and efficacy through the application of current pre-clinical science, non-clinical safety assessment, and toxicological principles and methods. These will be used 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 Director of Preclinical (Biocompatibility and Toxicology) 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).Duties and Responsibilities:Designing, planning, monitor various GLP toxicity studies, biocompatibility studies, and qualification of impurities with some supervisions from direct manager and senior members of the organizationAs sponsor representative and subject matter expert (SME) of biocompatibility collaborate with external testing facilities to complete biocompatibility testingParticipate as preclinical/toxicology representative and contribute in core technical team meetings as SME and provide inputs and lead task to be executed for completion of projects with effective collaboration and deliverablesParticipate in change control management and impact assessment. Propose options, work closely with stakeholders and develop action plan for problem-solving, product and process improvementMaintain current knowledge of relevant regulatory requirements related to toxicology, product development, design and safetyExecute tasks within budget at the project level to ensure the best utilization of financial resourcesQualifications:Relevant knowledge of ISO 10993 and ICH Q3 M7 guidelines requiredExperience in OECD and FDA Good Laboratory PracticeShown technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusionsAbility to work independently and prioritize assignments to meet project schedulesCan 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/CROsEducation and/or Experience: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/GMP environments:MS degree with 6 years or more of relevant experiencePhD with 3 years or more of relevant experienceProven experience with the conduct and execution of GLP nonclinical safety (toxicology) and toxicological risk assessment on Extractable & Leachable is highly preferredExperience with safety and biocompatibility evaluation of medical devices and related regulatory guidance (USP, ISOA 10993, EU MDR, etc)What Vantive can offer to you:A permanent contract with a stable and secure work environmentA comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus schemeA collaborative and dynamic work environmentAccess to state-of-the-art equipment and technologyRecognition and reward for outstanding performanceReasonable AccommodationVantive 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 LinkRecruitment Fraud NoticeVantive 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.
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