Process Development – Pre-Pivotal Biologics Attribute Sciences Associate

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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.

Let's do this. Let's change the world. In this vital role you will work closely with Attribute Sciences Team Leads (ASTLs) and cross-functional partners to support analytical development and product characterization for novel biotherapeutics. You will perform laboratory studies to characterize product quality attributes, develop and execute analytical methods, interpret and document experimental results, and support testing of development materials. You will contribute to understanding the stability, quality, and develop ability of candidate molecules and help establish the analytical foundation needed to advance programs toward the clinic.

This position offers the opportunity to work across a diverse portfolio of biologic modalities and collaborate with scientists across Research and Process Development while building broad experience in biopharmaceutical analytical development. The position is located at our Thousand Oaks, CA site.

• Perform analytical testing and characterization studies to evaluate product quality attributes and stability characteristics of biotherapeutics, with opportunities to take increasing ownership of study design and execution
• Co-verify and qualify analytical methods to enable GMP lab execution and support method establishment and validation activities at external sites through review of methods and validation protocols
• Support testing of drug substance, drug product, and other development materials to enable formulation, process development, stability, and product characterization studies
• Conduct product characterization studies using fraction collection, enzymatic digestions, and forced degradation to interrogate critical quality attributes
• Analyze, verify, interpret, and document experimental data, working closely with Attribute Sciences Team Leads (ASTLs) to support program needs and developing increasing independence in data interpretation and scientific problem solving
• Support preparation of technical reports, regulatory documentation, and scientific presentations through data compilation, verification, and analysis
• Evaluate and implement new analytical technologies to enhance product and attribute understanding
• Contribute to the development and implementation of digital capabilities, including automation of analytical data processing, visualization, and data management workflows
• Collaborate with cross-functional partners in Research, Process Development, Manufacturing, and external organizations to support advancement of pre-pivotal programs
• Steward analytical deliverables with accuracy, compliance, and adherence to Good Documentation Practices (GDP)

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