Roles and Responsibilities
- 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,s 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 instruments in charge.
- Training and mentoring of team members
- Provide scientific inputs on the matter related to toxicology
- Lead discovery or similar projects, coordination with stakeholders, and completion of tasks 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 the senior management team/department head
- Preparation and review of IB, IND, and NDA documents for regulatory submission
Desired Candidate Profile
Experience: 15 years