Manager-Risk Assessment, Toxicology-Tandalja (Rep. Prashant Gupta)

Brief description about the position

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?

1. Monitoring, planning and designing regulatory and Non-Regulatory Toxicity and Safety Studies in Rodents and Non-Rodents Species.
2. 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).
3. To perform work in compliance with the OECD principles of Good Laboratory Practice.
4. Ethics Protocol, Study Plan, Standard Operating Procedure (SOP) and Formats for respective studies preparations as per GLP (Good Laboratory Practice).
5. Support in literature search for ongoing projects
6. Due diligence of in-licensing projects
7. Maintain instruments used routinely in toxicity studies as instrument in charge.
8. Training and mentoring of team members
9. Provide scientific inputs on matter related to toxicology
10. Lead discovery or similar projects, coordination with stakeholders and completion of task as per agreed timelines
11. To prepare and review SEND documents for different SEND domains for toxicity studies
12. To participate intra/inter departmental meetings, project review meetings and present/discuss data pertaining to toxicology
13. To provide administrative support to senior management team/department head
14. Preparation and review of IB, IND and NDA documents for regulatory submission

Key Skills/Requirements

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