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 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