About This Role
Managing toxicological projects and providing expert consulting services to clients in the pharmaceutical, chemical, biotechnology, and food/consumer products industries is the core of this role. It offers an excellent opportunity to work alongside a senior team of recognized experts and receive comprehensive on-the-job training to develop skills in applied toxicology within a consulting environment.
Responsibilities
- Prepare, critically review, and approve high-quality toxicological hazard and risk assessments for pharmaceutical and biotechnology compounds, process intermediates, impurities, contaminants, and other materials
- Develop occupational toxicology documents, including occupational exposure limits (OELs), occupational health or hazard categorizations (OHCs), acceptable surface limits (ASLs), and safety data sheets (SDSs)
- Develop product safety assessments, including permitted or acceptable daily exposures (PDEs/ADEs), to support cleaning validation, cross-contamination control, and the assessment of impurities and other contaminants
- Evaluate the quality, relevance, and limitations of toxicology data; select appropriate points of departure and adjustment factors; and document transparent, scientifically defensible rationales
- Provide clients with practical toxicology, risk assessment, and regulatory-compliance advice relevant to pharmaceutical development and manufacturing
- Lead projects from scoping through delivery, including defining the technical approach, managing budgets and schedules, and maintaining clear client communication
- Support client relationships, proposals, and appropriate business-development activities within the candidate's areas of expertise
- Provide technical oversight, coaching, and review to other consultants, supporting consistent scientific quality and professional development
- Maintain current knowledge of relevant pharmaceutical guidance, toxicology methods, and regulatory expectations
Requirements
- Demonstrated experience conducting hazard and quantitative risk assessments
- Ability to critically evaluate animal, clinical, and mechanistic data, including limited datasets, and to document the application of weight of evidence, read-across, and uncertainty factors in a scientifically defensible manner
- Strong scientific writing skills, evidenced by authorship of toxicological assessments, health-based exposure limits, regulatory safety assessments, or comparable technical reports
- Ability to explain and defend scientific conclusions clearly to clients and colleagues and to translate them into practical risk-management advice
- Strong organizational and interpersonal skills, with the ability to manage multiple projects, priorities, and deadlines
- An advanced degree in toxicology, pharmacology, or a closely related discipline; a PhD is preferred; a relevant master's degree combined with strong directly applicable experience will also be considered
