Senior Scientist II, Occupational & Environmental Toxicologist
Core
Conduct risk assessments for occupational, environmental, and manufacturing safety to support regulatory filings and product development across therapeutic areas.
Role type
Senior Scientist II, Occupational & Environmental Toxicologist
Builds
Regulatory filings, safety banding strategies, and environmental/occupational risk assessments for marketed and developing products.
Domain
Pharmaceutical development, toxicology, regulatory compliance (ICH, GHS/CLP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk assessment authoring, literature and toxicology report evaluation, read-across and in silico data utilization, study planning and monitoring at CROs, regulatory guidance knowledge (ICH Q3C/Q3D/Q3E/M7, ISO-10993-X), toxicity data mining, GHS/CLP and SDS support, mentorship of junior staff
Preferred skills
Occupational Exposure Banding, Performance-based exposure control limits, new approach methodologies (NAM), QSAR tools proficiency, Board-certification
Technologies
QSAR tools, in silico predictive tools, CRO study management platforms
Responsibilities
Critically evaluate literature and toxicology reports to generate risk assessments; Support health-based exposure limits (HBELs), PDEs, and OELs; Engage in external working groups to drive industry standards; Provide guidance and mentorship to junior team members; Plan and monitor studies at CROs for environmental and worker safety assessments; Support occupational health hazard categorizations and chemical registrations.
Seniority
Senior, hands-on IC with mentorship responsibilities