Scientist, Immunogenicity Bioanalytical

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen is seeking a Scientist, Immunogenicity Bioanalytical in Thousand Oaks, CA to develop, validate, and implement ADA assays for nonclinical and clinical studies. You will ensure robust, regulatory-aligned immunogenicity analyses and collaborate with project teams and CROs to support risk assessment and decision making.

The role requires advanced degrees in immunogenicity bioanalysis, strong scientific problem solving, and the ability to work in a fast-paced multi-project environment with

Qualifications

• PhD in a relevant field is required.
• Master's degree with 2+ years immunogenicity bioanalytical experience.
• Bachelor's degree with 4 years immunogenicity bioanalytical experience.

Responsibilities

• Develop and optimize anti-drug antibody and pre-existing antibody assays across platforms.
• Validate ADA methods per current guidance and internal standards.
• Conduct GLP/GCP compliant sample analysis and report generation.
• Provide scientific oversight of work at internal and external labs.

Job description

Join Amgens 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.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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.

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.

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

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.