Scientific Director

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.

What You Will Do

Let’s do this. Let’s change the world! In this vital role, as a Scientific Director, Product Stewardship Toxicology, you will provide scientific and strategic leadership for Product Stewardship within the Environment, Health, Safety & Sustainability (EHSS) organization. You will lead a highly specialized toxicology function supporting development, commercialization and lifecycle management of Amgen products while ensuring patient safety, worker safety and regulatory compliance across our global operations.

This is a highly visible leadership position requiring deep expertise in pharmaceutical toxicology, occupational toxicology, product quality toxicology and extractables and leachable risk assessment.

As the Scientific Director and functional leader for Product Stewardship Toxicology, you will provide strategic scientific direction while building and continuously improving toxicology programs that support Amgen's product portfolio from early development through commercialization and post-market lifecycle management. The role is hybrid, option for remote work may be available.

Key responsibilities include:

• Lead the Product Stewardship Toxicology function within EHSS.
• Develop and mature toxicology strategies supporting global product development and commercialization.
• Provide scientific leadership across Product Development, Process Development, Quality, Manufacturing, Medical Device Engineering, Regulatory Affairs and EHSS.
• Influence enterprise decisions through expert toxicological risk assessment and strategic consultation.
• Build organizational capability and continuously improve toxicology processes, standards and governance.

• Lead toxicological assessments supporting:
• Extractables and Leachable (E&L)
• Single-use manufacturing systems
• Primary packaging
• Container closure systems
• Drug delivery devices
• Combination products
• Provide toxicology support for product quality investigations, non-conformances and product complaints.
• Develop scientifically robust toxicological risk assessments supporting regulatory submissions and quality decisions.
• Evaluate process-related impurities, reagents, excipients and manufacturing materials throughout product development.

• Lead Amgen's occupational toxicology strategy supporting safe manufacture and handling of pharmaceutical compounds.
• Perform and oversee Occupational Exposure Band (OEB) classifications.
• Derive Occupational Exposure Limits (OELs) using current scientific methodologies.
• Author and approve Hazard Assessment Monographs.
• Conduct worker health risk assessments for development compounds,…