Website Zydus Group Ltd
Post Name: Research Scientist – Biopharmaceutics & Clinical Development (Toxicology)
Experience range (Years): 4 years – 9 years
Drive Non-clinical pharmacokinetic studies in various species for animal health products.
Plan and design AMES, In vitro and In vivo Genotoxicity studies to support impurity qualification in Drug substances/Products.
Provide technical feedback for Non-Clinical Studies, including Pharmacokinetic and Toxicity studies.
Support study design and planning for tissue distribution studies.
Interpret Data and review study reports as per USFDA, ICH, OECD guidance for regulatory submissions.
Interface closely with in house facility and CROs, enabling completion of allocated projects within stipulated cost and timelines.
Well versed with Global guidance (ICH, OECD etc) and regulatory requirements.
Should possess excellent communication skills any work well as a team.