Scientist, Immunogenicity Bioanalytical

Career Category Scientific Job Description 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. Scientist, Immunogenicity Bioanalytical What you will do Let’s do this. Let’s change the world. In this vital role you will develop, validate, and implement bioanalytical methods for detection and characterization of anti-drug antibodies (ADA) in nonclinical and clinical studies. This assessment is important for understanding the immunogenicity profile of therapeutic molecules and its potential impact. You will ensure that immunogenicity assays and data are scientifically robust, fit for purpose, and aligned with current regulatory expectations. Through collaboration with project team representatives, external service provider labs, and other functional areas, you will contribute to immunogenicity risk assessment, regulatory submissions, and informed decision-making throughout drug development. The position is lab-based, and additional responsibilities will include critically reviewing and interpreting scientific data and results, report generation, project management, communication of results, data presentations, supporting automation efforts, and keeping current with technology development. In addition to regulated ADA bioanalysis, you will work on research focused work to understand and manage pre-existing antibody reactivity. This work requires critical scientific thinking to identify molecule specific assay challenges, design novel assay formats and reagents, and generate data that informs immunogenicity risk assessment and candidate selection early in development.

Develop and optimize sensitive, specific, and robust anti-drug antibody and pre-existing antibody assays using appropriate bioanalytical platforms and technologies (e.g., electrochemiluminescence based MSD). Design and execute validation of ADA methods in accordance with current regulatory guidance, industry best practices, and internal scientific standards. Conduct sample analysis in accordance with GLP and GCP guidelines Author and review bioanalytical documents, including validation reports and nonclinical/ clinical sample analysis study reports Develop appropriate mitigation strategies for challenging assay conditions, including high circulating drug concentrations, soluble target interference, pre-existing reactivity, matrix effects, and other molecule specific factors. Design and execute pre-existing antibody screening assays to support the pipeline, characterize molecules with positive pre-ADA reactivity using novel assay approaches, and independently apply critical scientific thinking to develop new strategies for complex therapeutic modalities. Provide scientific oversight of bioanalytical work conducted internally and/or at external CRO laboratories Maintain awareness of evolving regulatory expectations and advances in immunogenicity bioanalysis and apply relevant