Research Scientist I
About this role
About the Role Vantive seeks a Research Scientist I in Preclinical (Toxicology and Biocompatibility) to design and oversee toxicity and biocompatibility studies for drug/drug packaging systems and medical devices, ensuring safety for dialysis-related therapies. This role partners with a multidisciplinary team to develop toxicological risk assessments and prepare reports for regulatory bodies in line with ICH and ISO 10993-17. What You'll Do
- Design, plan, and monitor GLP toxicity studies and biocompatibility studies; qualify impurities with minimal supervision.
- Author toxicological risk assessment reports on leachables, extractables, residual solvents and excipients; review with SME in accordance with ICH and ISO 10993-17.
- Conduct hazard evaluation of manufacturing chemicals and issue safety data sheets (SDS).
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