Amneal Pharma has announced an exciting career opportunity for experienced professionals in the field of Toxicology. The company is looking for a Manager – Toxicology to join its team in Ahmedabad, Gujarat. Candidates with a strong background in pharmaceutical toxicology, risk assessment, regulatory sciences, and nonclinical development can apply for this leadership role.
If you have extensive experience in toxicological evaluations, pharmaceutical development, and GLP-compliant research, this opportunity offers an excellent platform to work with global cross-functional teams and contribute to innovative drug development programs.
Job Overview
| Particular | Details |
|---|---|
| Position | Manager – Toxicology |
| Company | Amneal Pharma |
| Location | Ahmedabad City, Gujarat, India |
| Job Type | Full Time |
| Experience | 10–12 Years |
| Qualification | M.Pharm / M.S. / MVSc / BVSc / M.Sc. and/or PhD in Toxicology or relevant Biomedical Science |
| Industry | Pharmaceutical / Life Sciences |
Key Roles & Responsibilities
The selected candidate will be responsible for:
- Conducting scientific literature searches and preparing expert reports.
- Performing toxicological risk assessments for pharmaceuticals, excipients, impurities, extractables and leachables (E&L), and chemicals.
- Establishing health-based exposure limits such as PDE and OEL for manufacturing facilities.
- Performing in silico (Q)SAR evaluations for mutagenicity, irritation, and sensitization assessments.
- Conducting n-nitrosamines and NDSRI safety assessments.
- Implementing alternative methodologies to replace traditional toxicology, PK, and PD studies.
- Providing nonclinical support for integrated product development including NDA 505(b)(2), ANDA, and complex generic products.
- Designing, monitoring, and resolving outsourced preclinical toxicology, pharmacokinetic, pharmacology, and tissue distribution studies.
- Planning and interpreting Enhanced Ames Test (EAT) and other in vitro/in vivo mutagenicity studies.
- Collaborating with Regulatory Affairs, Analytical R&D, Formulation R&D, Clinical, Quality, Manufacturing, and Project Management teams.
- Ensuring scientific integrity and maintaining animal welfare standards.
- Staying updated with scientific advancements and sharing technical knowledge across teams.
- Demonstrating sound understanding of Good Laboratory Practice (GLP) regulations.
- Leveraging AI tools to improve efficiency in routine scientific activities.
Required Qualifications
Candidates should possess one of the following qualifications:
- M.Pharm
- M.S.
- MVSc
- BVSc
- M.Sc.
- PhD in Toxicology or another relevant Biomedical Science discipline
Experience Required
- 10–12 years of relevant experience in pharmaceutical toxicology or related scientific domains.
Preferred Skills
- Passion for scientific research and continuous learning
- Strong verbal and written English communication skills
- Excellent collaboration skills within global cross-functional teams
- Ability to work independently while managing multiple projects and deadlines
- Expertise in toxicological risk assessment and regulatory science
- Knowledge of GLP regulations and modern toxicological methodologies
Salary & Benefits
Expected Salary: ₹28,00,000 – ₹40,00,000 per annum (Estimated based on similar industry roles, experience, and responsibilities).
Additional benefits may include:
- Performance-based incentives
- Health and wellness benefits
- Professional development opportunities
- Exposure to global research and development projects
- Collaborative and innovation-driven work environment
Why Join Amneal Pharma?
- Opportunity to work on complex pharmaceutical development projects
- Exposure to cutting-edge toxicology and regulatory science
- Global collaboration with multidisciplinary teams
- Career growth in one of the leading pharmaceutical organizations
- Opportunity to contribute to innovative healthcare solutions