Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences
Amgen
Summary
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.
Job description
Key Responsibilities
- 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.
Basic 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 industry experience
Preferred Qualifications
- Demonstrated expertise in the development, validation, and oversight of immunogenicity assays for detection of anti-drug binding and neutralizing antibodies according to current global regulatory guidelines
- Experience of working under the Good Laboratory Practices (GLPs) and knowledge of Good Clinical Practices (GCP) guidelines
- Experience in the transfer of immunogenicity assays to bioanalytical CROs
- Knowledge of statistical approaches applied to immunogenicity assays
- Knowledge of drug-tolerant assay formats for ADA and NAb detection
- Knowledge of cell-based assay formats for NAb detection
- Knowledge of predictive immunogenicity methods using cell based or ligand binding methods
- Supervisory and mentoring experience in a lab setting.
- Ability to analyze and interpret data to assist in assay development, validation, and troubleshooting.
- Ability to multi-task and manage multiple projects, strong verbal and written communication skills with a high degree of motivation, creativity and collaborative qualities.
- Previous experience working in a matrixed environment to implement immunogenicity assay development, validation, and sample analysis
- Project management skills to meet critical timelines associated with various activities necessary to support nonclinical and clinical studies.
- Ability to collaborate with cross-functional teams while also working independently
Requirements
- Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field 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 industry experience
- Demonstrated expertise in the development, validation, and oversight of immunogenicity assays for detection of anti-drug binding and neutralizing antibodies according to current global regulatory guidelines
- Experience of working under the Good Laboratory Practices (GLPs) and knowledge of Good Clinical Practices (GCP) guidelines
- Experience in the transfer of immunogenicity assays to bioanalytical CROs
- Knowledge of statistical approaches applied to immunogenicity assays
- Knowledge of drug-tolerant assay formats for ADA and NAb detection
- Knowledge of cell-based assay formats for NAb detection
- Knowledge of predictive immunogenicity methods using cell based or ligand binding methods
- Supervisory and mentoring experience in a lab setting
- Ability to analyze and interpret data to assist in assay development, validation, and troubleshooting
- Ability to multi-task and manage multiple projects, strong verbal and written communication skills with a high degree of motivation, creativity and collaborative qualities
- Previous experience working in a matrixed environment to implement immunogenicity assay development, validation, and sample analysis
- Project management skills to meet critical timelines associated with various activities necessary to support nonclinical and clinical studies
- Ability to collaborate with cross-functional teams while also working independently
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Spending Accounts
- Annual Bonus
- 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.