Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences

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. 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. Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences What you will do Let’s do this. Let’s change the world. The Pharmacokinetics & Drug Metabolism and Bioanalytical Sciences (PKDM-BA) organization is seeking to fill a Sr. Principal Scientist position in our Immunogenicity Bioanalytical Sciences (IGBA) group. In this vital role you will support the design, development, validation, and implementation of assays for the detection of binding and neutralizing anti-drug antibodies (ADAs & NAbs) for Amgen’s large molecule/protein therapeutics to support GLP preclinical and regulated clinical studies. Such molecules will inherently be diverse in nature and will require technical expertise in the implementation of suitable and innovative immunogenicity methods in accordance with global regulatory guidelines. This role will involve close collaboration with representatives from the drug development team, research groups, and compliance to ensure suitability of the assay format for the therapeutic program. You will work closely with an outsourcing team for the transfer of assays to global bioanalytical CROs. You will also be responsible for contributing to regulatory filing documents and for providing responses to questions received upon regulatory review.  Given the breadth of projects, this role will involve highly multidisciplinary interactions with scientists across research and development at Amgen and will provide an opportunity to supervise or mentor laboratory staff.

Provide scientific and strategic leadership for immunogenicity assay development, validation, transfer, and implementation across nonclinical and clinical programs. Serve as a senior subject-matter expert for ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assay approaches. Apply deep knowledge of global regulatory guidance, GLP/GCP expectations, and statistical assay validation principles to guide program decisions. Lead complex data interpretation, troubleshooting, and risk assessment to support immunogenicity bioanalytical strategy. Provide scientific oversight of  assay transfers to CROs, lead troubleshooting efforts while ensuring scientific quality, compliance, and timeline delivery. Influence cross-functional program teams and senior stakeholders in a matrixed environment. Mentor scientists and lead efforts to contribute to functional capability building, innovation, and best-practice development. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a scientist with these qualifications.

Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field [and relevant post-doc where applicable] and 3 years of scientific/technical industry experience OR Master’s degree and 6 years of scientific/technical industry experience OR Bachelor’s degree and 8 years of scientific/technical