Team member – In vitro In vivo toxicology.

Cipla · Mumbai, Maharashtra · Posted 9 days ago

About this role

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 authority submissions. Qualifications and Skills • Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine or related field. • Minimum 7-10 years of experience in experimental toxicology within the pharmaceutical, CRO or biotechnology industry. • Strong understanding of regulatory guidelines (e.g., ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions. • Proven ability to manage multiple projects simultaneously and work effectively in a dynamic t