Bioanalytical Portfolio Scientist

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 109,000 - 147,000; Full time

Job summary

Amgen Inc. (IR) seeks a Bioanalytical Portfolio Scientist to oversee outsourced immunogenicity assay methods, ensuring validation, performance, and regulatory compliance.

You will guide transfer, validation, and ongoing monitoring of ADA and NAb assays via CRO partners, while collaborating with internal experts to maintain data integrity and study quality. The role requires advanced degrees and experience in immunoassay development and CRO management, with strong communication skills and a

Qualifications

• Doctorate degree OR Master’s degree and 2 years of regulated scientific laboratory experience OR Bachelor’s degree and 4 years of regulated scientific laboratory experience.

Responsibilities

• Provides scientific and technical oversight for transfer, validation, and execution of immunogenicity assays (ADA and NAb).
• Leads transfer and validation of assays at external CROs.
• Collaborates with internal experts to ensure successful assay transfer and validation.
• Monitors assay performance and supports troubleshooting and continuous improvement.
• Oversees method lifecycle management including validation plans and reports.
• Reviews analytical data and ensures GLP/GCP compliance.

Skills

Immunoassay development

Validation & troubleshooting

Regulatory knowledge

CROs experience

Project management

Communication skills

Cross-functional collaboration

Negotiation

Influencing others

results oriented

Education

Doctorate degree

Master’s degree + 2 years experience

Bachelor’s degree + 4 years experience

Job description

Career Category Research Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Bioanalytical Portfolio Scientist

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as the technical subject matter expert for outsourced methods and is responsible to ensure adequate method validation and optimal method performance at CROs. The Bioanalytical Scientist is responsible for oversight of the outsourced bioanalytical phases of studies governed by applicable GLP/GCP principles. Individuals in this role will provide scientific and technical oversight of immunogenicity bioanalytical activities, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, conducted by external contract research organizations (CROs). Ensures adherence to validated methods, data integrity standards, study protocols, and applicable regulatory expectations. The ideal candidate will have a strong background of method development, validation, and troubleshooting, combined with excellent communication skills. This role is well suited for scientists who understand the dynamic of utilizing an externalized workforce and who thrive working with others in a collaborative manner.

Key Responsibilities:

• Provides scientific and technical oversight for the transfer, validation, and execution of immunogenicity assays, including anti-drug antibody (ADA) and cell based or non-cell based neutralizing antibody (NAb) assays, ensuring adherence to sponsor requirements and current regulatory expectations, industry best practices, and applicable scientific guidance.
• Leads the transfer and validation of assays at external CROs
• Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the immunogenicity methods to ensure successful assay transfer and validation
• Monitors assay performance over time and provides input for troubleshooting and continuous improvement efforts
• Accountable for method lifecycle management, including review of method validation plans, protocols, reports, and qualification of reagents and reference material
• Reviews analytical data, method protocol, validation/sample analysis plans, reports, and other study documentation for scientific accuracy and consistency with GLP/GCP documentation standards and current regulatory guidance
• Works with cross functional partners from CROs to navigate issue resolution and escalation utilizing the governance structure
• Provides subject matter expertise during supplier evaluation and monitoring activities
• Follows and contributes to guidance documents and SOPs
• Supports regulatory activities

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR Master’s degree and 2 years of regulated scientific laboratory experience OR Bachelor’s degree and 4 years of regulated scientific laboratory experience

Preferred Qualifications:

• Demonstrated expertise in Immunoassay development, validation, and troubleshooting for ADA and NAb (cell based or non-cell based) assays
• Knowledgeable on current regulatory expectations, industry best practices, and applicable scientific guidance
• Experienced in working with CROs
• Project and people management
• Process management and planning skills
• Excellent written and verbal communication skills
• Collaborates, negotiates and persuades others, both internally and externally
• Openly promotes cooperation across the organization
• Project and issue management skills
• Drives for results; delivers processes and outcomes of the highest quality
• Consistently communicates in a manner that is appropriate to the situation

What you can expect of 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, we’ll 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.

Sponsorship

Sponsorship for this role is not guaranteed.

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

External/Internal postings: 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. Internal only posting (or Pre-ID candidate): Amgen anticipates accepting applications until 1 week before the posting; however, we may continue accepting applications beyond this date if we do not receive a sufficient number of candidates.

Equal Opportunity

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 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.

Salary Range

109,020.15USD -147,497.85 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen