Job Description
We are seeking a Assistant Manager / Deputy Manager in Global Toxicology & Nonclinical Development to lead safety and risk assessments for generic drugs, impurities, excipients, and E&L.
Responsibilities include authoring expert reports, managing outsourced preclinical toxicology, PK/PD, and mutagenicity studies, and implementing alternative methodologies.
The role involves establishing health-based exposure limits (PDE, OEL), performing in silico (Q)SAR evaluations, conducting n-nitrosamine risk assessments, and supporting NDA 505(b)(2), ANDA, and complex generics development across multiple dosage forms.
Collaboration with global cross-functional teams is key, along with ensuring GLP compliance, scientific integrity, and animal welfare.
Candidates should have strong scientific passion, excellent communication skills, and the ability to manage multiple priorities independently in a fast-paced environment.
Qualifications
- M.Pharm/M.S./MVSc/BVSc/MSc and/or PhD in toxicology or other relevant biomedical science discipline up to 7-12 years of relevant experience.
- Board certification as toxicologist (DABT, ERT, or equivalent) is advantage, but not mandatory.
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
About The Team
The
Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.