Description
- 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 skilled expertise by staying current with industry developments and sharing knowledge internally.
- Demonstrate sound understanding of Good Laboratory Practice (GLP) regulations.
- Use of AI for improved efficiency in routine work

Additional Responsibilities:

Qualifications
Qualifications and Education Requirements
M.Pharm/M.S./MVSc/BVSc/MSc and/or PhD in toxicology or other relevant biomedical science discipline 10-12 years of relevant experience.
Board certification as toxicologist (DABT, ERT, or equival

📌 Manager, Toxicology (Ahmedabad)
🏢 Amneal
📍 Ahmedabad