Team member – In vitro In vivo toxicology.

Designation - Deputy Manager Job Description: Team member – In vitro In vivo toxicology . 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 toxicological data and prepare Investigational Brochures (IBs), Investigational New Drug (IND) applications, and electronic Common Technical Document (e-CTD) for regulatory a...