Scientist, Immunogenicity Bioanalytical

BioSpace; Thousand Oaks (CA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Retirement plan

Medical/dental/vision coverage

Annual bonus program

Stock-based incentives

Flexible work options

Job summary

Amgen in Thousand Oaks is seeking a Scientist, Immunogenicity Bioanalytical to develop, validate, and implement ADA and pre-existing antibody assays in nonclinical and clinical studies, ensuring immunogenicity data are robust and regulatory-ready.

You will collaborate across project teams and external labs, review data, generate reports, support automation, and contribute to risk assessment and candidate selection early in development.

Qualifications

• PhD or equivalent in biology, pharmacology, or related field.
• Experience in immunogenicity bioanalysis is required or strongly preferred.
• Knowledge of regulatory expectations in GLP/GCP.

Responsibilities

• Develop and validate ADA and pre-existing antibody assays.
• Validate ADA methods per regulatory guidance.
• Conduct sample analysis under GLP and GCP.
• Prepare and review bioanalytical reports and study reports.
• Oversee external CRO bioanalytical work.
• Support regulatory submissions and immunogenicity risk assessment.

Skills

Immunogenicity Bioanalysis

GLP/GCP knowledge

Bioanalytical assay execution

Project management

Cross-functional collaboration

Education

PhD in a related field

Master's degree with Immunogenicity Bioanalytical experience

Bachelor's degree with Immunogenicity Bioanalytical experience

Job description

Join Amgen's Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets 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.

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

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Scientist we seek is a professional with these qualifications.

Basic Qualifications

• Doctorate degree PhD
• OR
• Masters degree and 2 years of Immunogenicity Bioanalytical experience
• OR
• Bachelors degree and 4 years of Immunogenicity Bioanalytical experience

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.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

Benefits

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

• 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. Refer to the Work Location Type in the job posting to see if this applies.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.