Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences

Amgen • Thousand Oaks, CA

1d • $165,501 - $223,913

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

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.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree