Manager, Toxicology

• 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