About the Company
Vantive is a vital organ therapy company dedicated to extending lives and expanding possibilities for patients and care teams worldwide. With 70 years of innovation in kidney care, Vantive is committed to elevating the dialysis experience through digital solutions and advanced services, while also exploring beyond kidney care to transform vital organ therapies. The company aims to provide greater flexibility and efficiency in therapy administration for care teams and longer, fuller lives for patients.
Job Summary
The Research Scientist I, specializing in Preclinical (Toxicology and Biocompatibility), will apply expertise in toxicology and medical device biocompatibility testing. This includes developing toxicity study designs and biocompatibility testing designs for drug/drug packaging systems and medical device development, monitoring studies, and developing toxicological risk assessments. The successful candidate will have hands-on experience in hazard evaluation of chemicals used in manufacturing and will contribute to preparing reports for external regulatory bodies in accordance with ICH and ISO10993-17. This role offers an opportunity to join a highly matrixed multidisciplinary team responsible for ensuring the safety of drugs and medical devices for Peritoneal dialysis, Hemodialysis, and Acute therapies.
Essential Duties And Responsibilities
- Work independently in designing, planning, and monitoring various GLP toxicity studies and biocompatibility studies, and qualification of impurities with minimal supervision.
- Author toxicological risk assessment reports on leachables, extractables, residual solvents, and excipients, and review or concur with toxicology assessment reports as a Subject Matter Expert (SME) in accordance with ICH and ISO10993-17.
- Conduct hazard evaluations of chemicals used in manufacturing and issue Safety Data Sheets (SDS).
- Participate as a preclinical/toxicology representative in core technical team meetings, contributing as an SME, providing input, and leading tasks for project completion through effective collaboration.
- Participate in change control management and impact assessment. Propose options, collaborate with stakeholders, and develop action plans for problem-solving and product/process improvement. Prepare and/or review nonclinical eCTD and PBRER sections. Utilize in silico tools to assess toxicological endpoints.
- Independently plan and execute a series of design or technical tasks that may not be well-defined and have multiple variables within negotiated deadlines.
- Develop new approaches to complex problems by adapting and modifying standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes.
- Collaborate with team members and cross-functional teams, provide and accept constructive feedback, resolve conflicts, and work as a team to complete projects with quality and within defined timelines.
Qualifications
- Relevant technical knowledge in toxicology and biocompatibility testing.
- Demonstrated ability to understand and apply global regulatory guidelines including OECD and FDA GLP, ICH Q3 guidelines, ISO 10993.
- Excellent oral and written communication in English.
- Ability to utilize a logical, methodical approach when problem-solving, developing solutions, and making recommendations.
- Ability to work independently and prioritize assignments to meet project schedules.
- Ability to design experiments, monitor toxicology studies, interpret results, draw meaningful conclusions from data, and prepare reports for external regulatory bodies.
Education And/or Experience
- Master of Life Sciences/Veterinary/Biotechnology/Pharmacy (or relevant) with a minimum of 12 to 15 years of relevant work experience, OR
- PhD &/or Post-doc with 8 to 10 years of relevant experience in areas such as in vitro and in vivo pharmacological (preferably sterile injectable/parenteral formulations), toxicological studies and risk assessment of chemicals, and biocompatibility testing of medical devices and drug packaging systems.
Skills
- Demonstrated ability in clear and effective communication (written, oral) and presentation skills to global stakeholders. Fluency in English.
- Solid computer skills: email, good documentation practice, and collaboration tools such as Zoom, Teams, and Microsoft Office products.
- Demonstrated ability to work in a matrix environment with multiple stakeholders.
- Demonstrates flexibility and the ability to shift between projects comfortably.
- Proven ability to deliver results by owning and being accountable for budget, timeline, and product/project deliverables.