Toxicology and PKPD Study Lead

Designation - Deputy Manager

Job Description: Team member – In vitro In vivo toxicology.

1. Key Responsibilities: Experimental Toxicology & Preclinical Research

• Develop preclinical strategies supporting differentiated product development.
• Plan, outsource, oversee, and interpret in vitro and in vivo preclinical toxicology and pharmacokinetics/pharmacodynamics (PK/PD) studies for NCE or complex/differentiated products, vaccines, biological products
• Plan, outsource, oversee, and interpret impurity qualifications studies.
• Plan, outsource, oversee, and interpret in vivo/ in vitro genotoxicity studies.
• Plan, outsource, oversee, and interpret in vivo/ in vitro biocompatibility studies for medical devices.
• Plan, outsource, oversee, and interpret in vitro immunogenicity studies for peptides and biosimilar products.
• Summarize toxicologica...