Senior Principal Scientist
Core
Senior toxicologist managing patient safety and EHSS risks for Amgen products from development through commercialization and post-approval.
Role type
Senior Principal Scientist (Toxicology)
Builds
Toxicology assessments for drugs, manufacturing materials, primary containers, and drug-delivery device combination products.
Domain
Biopharmaceuticals / Environmental Health, Safety, and Sustainability (EHSS)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
toxicology assessments, leachable/extractables testing, biocompatibility evaluations (ISO 10993-1), occupational exposure band classification (OEBs), hazard assessment (GHS), occupational exposure limit derivation (OELs), regulatory compliance (ICH M7, EU GMP), scientific literature review, risk-based toxicology assessments
Preferred skills
toxicology board certification (DABT/ERT), chemical characterization of packaging/device materials, PQRI/BPOG industry practices, computational toxicology tools (OECD Toolbox, Toxtree, BMD), toxicological risk assessment reporting, project management
Technologies
ISO 10993-1, ISO 10993-17, ICH M7, GHS, OECD Toolbox, Toxtree, Benchmark Dose (BMD), EndNote
Responsibilities
Prepare toxicological assessments of leachable and extractables data; support device organization with biocompatibility evaluations; manage toxicology assessments of process reagents and excipients; conduct patient and worker safety risk assessments; classify drug candidates into Occupational Exposure Bands; derive Occupational Exposure Limits; monitor scientific developments and regulations; support regulatory compliance and external scientific initiatives
Seniority
Senior, hands-on IC