Amneal Pharmaceuticals Hiring for Toxicology and Nonclinical Development

Amneal Pharmaceuticals, Inc is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines. Amneal is a global essential medicines company powered by a robust U.S. generics business. Amneal is a growing branded business with deepening portfolios in institutional injectables, biosimilars and select international markets including India.

Post : Assistant Manager/ Deputy Manager /Manager

Department : Toxicology and Nonclinical Development

Location : Ahmedabad, Gujarat (Corporate Office)
Qualification : BVSc/ MVSc/ M.Pharm / MSc and / or PhD in toxicology
Experience : 7-12 years
Required skills :
• Nonclinical studies-design, conduct, interpret and and/'or out source to CROs.
• Generics : 505b2(NDA) requirements on regulatory nonclinical studies.
• Impurity qualification as per ICH requirements.
• Toxicology Risk assessment of drugs, impurities and excipients.
• Leachable and Extractable toxicological risk assessment.
• Genotoxicity assessment of drugs/chemicals/impurities - PDE/OEL determination.
• Addressing regulatory agency queries Involved in non-clinical study execution &audit.