Senior Principal Scientist - Thousand Oaks, CA

Military Spouse Corporate Career Network•Thousand Oaks, CA

4d•Hybrid

About The Position

At Amgen, we are driven by our shared mission to serve patients living with serious illnesses. Since 1980, we have been pioneers in the biotech industry, fighting the world's toughest diseases. Our focus spans four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease, impacting millions of patients annually. We are advancing a broad pipeline of medicines for cancer, heart disease, inflammatory conditions, rare diseases, and obesity. As a member of the Amgen team, you will contribute to making a lasting impact on patients' lives by researching, manufacturing, and delivering innovative medicines. Our collaborative, innovative, and science-based culture fosters growth for those passionate about challenges. Join us to transform patient lives and your career.

Requirements

Doctorate degree (PhD OR PharmD OR MD) and 2 years of toxicology experience OR Master’s degree and 5 years of toxicology experience OR Bachelor’s degree and 7 years of toxicology experience

Nice To Haves

MS or Ph.D. in toxicology, pharmacology, or related health sciences
Toxicology board certification (DABT or ERT)
Minimum 5 years of experience in the pharmaceutical/biotech industry
Experience with the principles and practice of leachable/extractables studies, chemical characterization of packaging and device materials/components, and risk-based toxicology assessments of extractables and leachable
Knowledgeable of industry practice (e.g., PQRI, BPOG), as well as regulatory guidelines and standards (e.g., ICH, ISO) to support extractable/leachable assessments
Research skills with literature searches, toxicology databases, regulatory databases, and computational tools (e.g., OECD Toolbox, Toxtree, Benchmark Dose (BMD))
Expert knowledge with resourceful data interpretation for derivation of toxicology-based limits (e.g., Permissible Daily Exposure values) and application of thresholds of toxicological concern (ICH M7 TTC, Cramer TTC)
Prepare toxicological risk assessment reports on product quality and safety
Experience in hazard/risk assessment within pharmaceutical and/or biopharmaceutical industry
Working knowledge of biocompatibility evaluations (ISO10993-1) for medical devices and drug-device combination products
Good understanding of pharmaceutical development
Strong scientific and technical writing skills and proficiency with EndNote or equivalent
Proficiency in Microsoft Office and other computer software systems
Strong team building skills
Process driven with a strong Operational Excellence mindset and project management skills
Strong communication and presentation skills, action oriented, self-starting, program development and project management

Responsibilities

Mature core toxicology programs to manage patient safety and EHSS risks of Amgen products, including drugs, manufacturing materials, primary containers, and drug-delivery device combination products, from development to commercialization and post-approval.
Perform CMC/Quality toxicology assessments and support Occupational toxicology.
Prepare toxicological assessments of leachable and extractables testing data related to single-use manufacturing, primary drug containers, delivery devices, and drug-device combination products.
Support the device organization with expertise on biocompatibility evaluations (ISO 10993-1) and leachable substances (ISO 10993-17) for medical devices.
Prepare and/or manage toxicology assessments of process reagents and excipients used in Amgen drug development processes and formulations.
Prepare product quality toxicology assessments to support non-conformances and product complaints.
Conduct or assist with patient and/or worker safety risk assessments.
Classify drug candidates into Occupational Exposure Bands (OEBs) for worker safety and categorize hazards according to the Globally Harmonized Standard (GHS) for Safety Data Sheets (SDSs) and labeling to support worker safety.
Derive Occupational Exposure Limits (OELs) for drug candidates and document them in product Hazard Assessment Monographs to support worker safety.
Monitor scientific developments, conduct desktop research including literature searches, and critically evaluate and summarize scientific information and government regulations.
Support scientific work including regulatory compliance, trade associations, and professional organizations relevant to work assignments.
Coordinate Amgen EHSS contributions for influencing external scientific and regulatory activities and key initiatives such as ICH M7 (mutagenic impurities) and updates to EU GMPs (setting health-based limits for pharmaceuticals).