* Conduct literature searches and author expert reports, scientific position
papers, safety and toxicological risk assessments (TRA) for pharmaceuticals,
extractables and leachables (E&L;), excipients, impurities and other
chemicals.
* Establish health-based exposure limits (e.g., PDE, OEL) for manufacturing
plants.
* Perform in silico (Q)SAR evaluations for mutagenicity, irritation,
sensitization; derive acceptable intake limits and justify higher impurity
levels using alternate toxico-regulatory approaches.
* Conduct n-nitrosamines/NDSRI safety assessments.
* Explore and implement novel alternative methodologies to replace traditional
toxicology/PK/PD studies using appropriate systems.
* Provide nonclinical support for integrated product development, including NDA
505(b)(2) andA applications and complex generics across injectable,
ophthalmic, inhalation, oral and topical products.
* Design, organize, monitor and resolve issues for outsourced preclinical




toxicology, pharmacokinetics (PK), pharmacology and tissue distribution
studies with external CROs.
* Plan, outsource, monitor and interpret Enhanced Ames Test (EAT) and other in
vitro and in vivo mutagenicity studies at external CROs.
* Collaborate proactively within global cross-functional teams (Regulatory
Affairs, Analytical R&D;, Formulation R&D;, Project Management, Clinical,
Quality, Manufacturing).
* Ensure scientific integrity and animal welfare in all activities.
* Maintain technical and professional expertise by staying current with
industry developments and sharing knowledge internally.
* Demonstrate sound understanding of Positive Laboratory Practice (GLP)
regulations.
* Use of AI for improved efficiency in routine work

Additional Responsibilities:

📌 Manager, Toxicology (Ahmedabad)
🏢 Amneal
📍 Ahmedabad