This role requires relevant skills sets to toxicology pathology research and act as study pathologist for toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.

What are the key responsibility of the role?

• Monitoring, planning and designing regulatory and Non-Regulatory Toxicity and Safety Studies in Rodents and Non-Rodents Species.
• To conduct long term toxicity studies (7/14/28/90 Days and 6 months) including carci study studies by different routes of administration viz. Oral (gavage), Intraperitoneal, Intravenous, Subcutaneous, Intramuscular, Intradermal, dermal application, Inhalation, Intra-tracheal, Intravaginal, etc. in rodents (rat, mouse, hamster, guinea pig) and non-rodents species (rabbit and dog).
• To perform work in compliance with the OECD principles of Good Laboratory Practice.
• Ethics Protocol, Study Plan, Standard Operating Procedure (SOP) and Formats for respective studies preparations as per GLP (Good Laboratory Practice).
• Support in literature search for ongoing projects
• Due diligence of in-licensing projects
• Maintain instruments used routinely in toxicity studies as instrument in charge.
• Training and mentoring of team members
• Provide scientific inputs on matter related to toxicology
• Lead discovery or similar projects, coordination with stakeholders and completion of task as per agreed timelines
• To prepare and review SEND documents for different SEND domains for toxicity studies
• To participate intra/inter departmental meetings, project review meetings and present/discuss data pertaining to toxicology
• To provide administrative support to senior management team/department head
• Preparation and review of IB, IND and NDA documents for regulatory submission

Key skills and requirement:

• M. Sc. /M. Pharm /Ph. D with 8 to 14 years of relevant experience
• Knowledge and experience of toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.