Nicholas Roden

Background

About Nicholas Roden

Experienced in multiple facets of occupational and environmental toxicology. GLP Toxicity Testing, Occupational Exposure Limits (OELs) Occupational Exposure Band (OEBs), Safety Data Sheets (SDSs), Chemical Hazard and Risk Assessment for process, product and manufacturing impurities (ICH). Work with teams implementing controls in potent pharmaceutical actives including sensitizers and hormones integrated with Industrial Hygiene and Operations across pharmaceutical research and manufacturing. Expert in planning, budgeting, implementing and manager of multiyear toxicology testing programs for occupational and environmental evaluations. Prepare pharmaceutical environmental risk assessments for agency submissions (EMA). Establish PDEs for cleaning limits. Train and mentor staff. Set up and manage SDS systems. Conducting portfolio reviews for long term planning and resource needs assessment. Lead and participate in process improvement teams. Track environmental issues for analysis and corporate action from industry groups. Specialties: Occupational and Environmental Risk Assessments, OEL/OEB, Impurity Assessments, SDS & Hazard Communications, Product Stewardship, Mammalian and Environmental Toxicity Testing