Scientist, Immunogenicity Bioanalytical
Amgen
Summary
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.
Job description
Key Responsibilities
- 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 developments to bioanalytical strategies.
- Contribute to scientific innovation through evaluation of new technologies and development of improved methodologies.
Preferred Qualifications
- Prior experience in pharma/biotech strongly desired.
- Prior GLP and GCP experience.
- Prior experience in bioanalytical (regulated) assay execution and method transfer to external contract laboratories.
- Understanding of immunology, immunogenicity, antibody biology, or a related field.
- Must be willing to work in a fast-paced, multi-project environment with high workload demands, and consistently deliver high-quality results within established timelines.
- Demonstrated ability to efficiently resolve scientific challenges, prioritize and effectively manage multiple projects.
- Excellent scientific problem-solving skills.
- Excellent project and time management abilities.
- Ability to work collaboratively with internal and external stakeholders.
Requirements
- Doctorate degree PhD OR Master's degree and 2 years of Immunogenicity Bioanalytical experience OR Bachelor's degree and 4 years of Immunogenicity Bioanalytical experience
- Prior experience in pharma/biotech strongly desired
- Prior GLP and GCP experience
- Prior experience in bioanalytical (regulated) assay execution and method transfer to external contract laboratories
- Understanding of immunology, immunogenicity, antibody biology, or a related field
- Must be willing to work in a fast-paced, multi-project environment with high workload demands, and consistently deliver high-quality results within established timelines
- Demonstrated ability to efficiently resolve scientific challenges, prioritize and effectively manage multiple projects
- Excellent scientific problem-solving skills
- Excellent project and time management abilities
- Ability to work collaboratively with internal and external stakeholders
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Spending Accounts
- Annual Bonus Program
- Stock-based Long-term Incentives
- Paid Time Off
- Flexible Work Models
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.