Manager, Toxicology

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Amneal Pharmaceuticals in India seeks a senior toxicology specialist to drive safety assessments across pharmaceuticals and related chemicals. You will conduct literature reviews, safety risk assessments, and in silico evaluations to set exposure limits and justify impurity levels.

You will collaborate with global teams and oversee preclinical CROs, ensuring GLP compliance and scientific integrity. The role emphasizes innovative methodologies, regulatory alignment, and high-level scientific

Qualifications

• M.Pharm/M.S./MVSc/BVSc/MSc and/or PhD in toxicology or a related biomedical science discipline; 10–12 years of relevant experience.
• Board certification as toxicologist (DABT, ERT, or equivalent) is advantageous but not mandatory.
• Excellent verbal and written English communication; ability to collaborate with global cross-functional teams.
• Demonstrated passion for science and continuous learning.

Responsibilities

• Conduct literature searches and author expert reports, safety and toxicological risk assessments for pharmaceuticals and chemicals.
• Establish health-based exposure limits for manufacturing plants.
• Perform in silico (Q)SAR evaluations and derive acceptable intake limits.
• Conduct safety assessments for nitrosamines and NDSRIs.
• Explore novel alternatives to replace traditional toxicology studies using suitable systems.
• Provide nonclinical support for product development including NDA 505(b)(2) applications.
• Coordinate outsourced preclinical toxicology and PK/PD studies with CROs.

Skills

Toxicology

English comms

Cross-functional

Project mgmt

Education

M.Pharm/M.S./MVSc/BVSc/MSc

PhD in toxicology

Tools

Q)SAR software

AI tools

Job 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 professional 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

Job 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 professional 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 equivalent) is advantage, but not mandatory.

Preferred Skills

• Demonstrated passion for science and continuous learning
• Excellent verbal and written English communication skills
• Proven ability to collaborate effectively within diverse, global, cross-functional teams
• Ability to work independently and manage multiple deliverables and timelines in a fast-paced environment