Senior Principal Scientist
Amgen
August 06, 2026
Remote friendly (Thousand Oaks, CA)
United States
Clinical Research and Development
Senior Principal Scientist
Responsibilities:
- Mature core toxicology programs to manage patient safety and EHSS risks across development to post-approval.
- Perform CMC/Quality toxicology assessments and support Occupational toxicology.
- Prepare toxicological assessments of leachable/extractables for single-use manufacturing, primary drug containers, delivery devices, and drug-device combination products.
- Perform biocompatibility evaluations (ISO 10993-1) and leachable assessments (ISO 10993-17) for medical devices.
- Prepare/manage toxicology assessments for process reagents and excipients.
- Prepare product quality toxicology assessments to support non-conformances and product complaints.
- Conduct/assist patient and/or worker safety risk assessments.
- Classify hazards for SDS/labeling (GHS), assign Occupational Exposure Bands (OEBs), and derive Occupational Exposure Limits (OELs).
- Conduct literature/desktop research and critically evaluate scientific/regulatory information; support regulatory compliance and external scientific activities (e.g., ICH M7, EU GMP updates).
- Hybrid role (remote option may be available).
Basic Qualifications:
- PhD/PharmD/MD (plus relevant post-doc where applicable) and 2 years toxicology experience; OR Master’s and 5 years; OR Bachelor’s and 7 years.
Preferred Qualifications/Skills:
- MS/PhD in toxicology/pharmacology/related field; DABT/ERT; 5+ years in pharma/biotech.
- Leachable/extractables and risk-based toxicology experience; knowledge of PQRI/BPOG; ICH/ISO; research and computational tools (e.g., OECD Toolbox, Toxtree, BMD).
- Expertise deriving toxicology-based limits (e.g., PDE) and applying TTC (ICH M7, Cramer).
- Writing skills; EndNote (or equivalent); Microsoft Office; project management and strong communication/presentation.
What you can expect (benefits if eligible):
- Medical/dental/vision, life/disability, flexible spending; retirement/savings plan; annual bonus/incentives; stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply now via careers.amgen.com. No application deadline; sponsorship not guaranteed.
Responsibilities:
- Mature core toxicology programs to manage patient safety and EHSS risks across development to post-approval.
- Perform CMC/Quality toxicology assessments and support Occupational toxicology.
- Prepare toxicological assessments of leachable/extractables for single-use manufacturing, primary drug containers, delivery devices, and drug-device combination products.
- Perform biocompatibility evaluations (ISO 10993-1) and leachable assessments (ISO 10993-17) for medical devices.
- Prepare/manage toxicology assessments for process reagents and excipients.
- Prepare product quality toxicology assessments to support non-conformances and product complaints.
- Conduct/assist patient and/or worker safety risk assessments.
- Classify hazards for SDS/labeling (GHS), assign Occupational Exposure Bands (OEBs), and derive Occupational Exposure Limits (OELs).
- Conduct literature/desktop research and critically evaluate scientific/regulatory information; support regulatory compliance and external scientific activities (e.g., ICH M7, EU GMP updates).
- Hybrid role (remote option may be available).
Basic Qualifications:
- PhD/PharmD/MD (plus relevant post-doc where applicable) and 2 years toxicology experience; OR Master’s and 5 years; OR Bachelor’s and 7 years.
Preferred Qualifications/Skills:
- MS/PhD in toxicology/pharmacology/related field; DABT/ERT; 5+ years in pharma/biotech.
- Leachable/extractables and risk-based toxicology experience; knowledge of PQRI/BPOG; ICH/ISO; research and computational tools (e.g., OECD Toolbox, Toxtree, BMD).
- Expertise deriving toxicology-based limits (e.g., PDE) and applying TTC (ICH M7, Cramer).
- Writing skills; EndNote (or equivalent); Microsoft Office; project management and strong communication/presentation.
What you can expect (benefits if eligible):
- Medical/dental/vision, life/disability, flexible spending; retirement/savings plan; annual bonus/incentives; stock-based long-term incentives; time-off; flexible work models where possible.
Application instructions:
- Apply now via careers.amgen.com. No application deadline; sponsorship not guaranteed.