Elevating Life-Changing Products
We are a pioneering force in vital organ therapy, driven by innovation and a commitment to improving patients' lives worldwide. Our mission is to transform the dialysis experience through digital solutions and advanced services.
As a Research Scientist at our organization, you will join a community of focused, courageous individuals who share our passion for making a difference. You will be part of a global team responsible for developing life-changing products that impact millions of people globally.
Your role as a Preclinical Biocompatibility and Toxicology SME (Research Associate III) will involve applying your expertise in toxicology and medical device biocompatibility testing. You will design and monitor GLP toxicity studies, collaborate with external testing facilities, and participate in core technical team meetings. Your contributions will ensure the safety and efficacy of our products through current pre-clinical science, non-clinical safety assessment, and toxicological principles and methods.
You will report to the Director of Preclinical (Biocompatibility and Toxicology) and work closely with stakeholders to propose options, develop action plans, and execute tasks within established guidelines. Your ability to communicate complex study results, safety evaluations, and toxicology assessment conclusions effectively will be essential in this role.
Key Responsibilities:
* Designing, planning, monitoring various GLP toxicity studies, biocompatibility studies, and qualification of impurities with some supervisions from direct manager and senior members of the organization
* Collaborating with external testing facilities to complete biocompatibility testing
* Participating in change control management and impact assessment
* Proposing options, working closely with stakeholders, and developing action plans for problem-solving, product and process improvement
* Maintaining current knowledge of relevant regulatory requirements related to toxicology, product development, design, and safety
Qualifications:
* Relevant knowledge of ISO ***** and ICH Q3 M7 guidelines required
* Experience in OECD and FDA Good Laboratory Practice
* 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
Education 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 experience
PhD with 3 years or more of relevant experience