Senior Principal Scientist

Amgen • Thousand Oaks, CA

7d • Hybrid

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Principal Scientist What you will do Let’s do this. Let’s change the world! We are seeking an experienced toxicologist in the Product Stewardship group within our Environment, Health, Safety and Sustainability (EHSS) organization. This position has a broad reach and supports: bringing new drugs to market, and ensuring patient and staff safety In this role you will mature core toxicology programs to manage patient safety and EHSS risks of Amgen products, including those from drugs, manufacturing materials, primary containers, and drug-delivery device combination products, as they advance from development to commercialization, and post-approval. Primary role includes performing CMC/Quality toxicology assessments and supporting Occupational toxicology.

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] 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) and 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 the industry practice (e.g. PQRI, BPOG), as well as regulatory guidelines and standard (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

• Prepare toxicological assessments of leachable and extractables testing data as they relate to single-use manufacturing, primary drug containers, delivery devices and drug-device combination products.
• Support device organization with expertise on biocompatibility evaluations (ISO 10993-1) and more specifically on 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 documented in product Hazard Assessment Monographs, to support worker safety.
• Monitor scientific developments and 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).

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree