Toxicology and Nonclinical Development Manager opportunity at Amneal Pharmaceuticals- Apply before 15th July 2024

About Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is a global leader in the pharmaceutical industry, committed to making health more accessible and achievable. With a dedicated team of over 7,500 colleagues, we develop, manufacture, and distribute a diverse portfolio of more than 270 high-quality medicines. Our strength lies in our robust U.S. generics business, complemented by our expanding branded business in institutional injectables, biosimilars, and select international markets, including India.

Job Title

Assistant Manager/Deputy Manager/Manager

Department

Toxicology and Nonclinical Development

Location

Ahmedabad, Gujarat (Corporate Office)

Qualifications

• BVSc/ MVSc/ M.Pharm / MSc and/or PhD in toxicology

Experience

• 7-12 years

Required Skills

• Nonclinical Studies: Proficiency in designing, conducting, interpreting, and/or outsourcing nonclinical studies to Contract Research Organizations (CROs).
• Generics: Knowledge of 505(b)(2) New Drug Application (NDA) requirements for regulatory nonclinical studies.
• Impurity Qualification: Understanding of impurity qualification as per International Council for Harmonisation (ICH) guidelines.
• Toxicology Risk Assessment: Expertise in toxicology risk assessment of drugs, impurities, and excipients.
• Leachable and Extractable Risk Assessment: Skills in assessing toxicological risks of leachables and extractables.
• Genotoxicity Assessment: Ability to conduct genotoxicity assessments of drugs, chemicals, and impurities, including Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) determinations.
• Regulatory Queries: Experience in addressing regulatory agency queries related to nonclinical study execution and audits.

Application Details

• Last Date to Apply: 15th July 2024
• How to Apply: Interested candidates can share their CVs via email at kavitriy@amneal.com

Join Amneal Pharmaceuticals and be a part of our mission to make healthy possible through innovative pharmaceutical solutions!