Scientist, Bioanalytical Sciences

Amgen Inc. (IR); Northern (KY); Hybrid; USD 109,000 - 147,000; Full time

Job summary

Amgen Inc. in the United States is seeking a Scientist, Bioanalytical Sciences to oversee PK assay transfer, validation, and performance across CROs.

The role emphasizes GLP/GCP compliance, method development, and collaboration with internal SMEs; strong communication is essential, with experience in ELISA, ECL, LC-MS/MS and ligand-binding assays.

Qualifications

• Doctorate degree [and relevant post-doc where applicable] OR Master’s degree and 2 years of regulated commercial scientific laboratory experience OR Bachelor’s degree and 4 years of regulated commercial scientific laboratory experience
• Experience in PK assay development, validation, and troubleshooting for LBA, LC-MS or hybrid assays
• Knowledge of FDA, ICH, EMEA, NMPA guidance/regulations
• Experience working with CROs
• Excellent written and verbal communication skills

Responsibilities

• Provides scientific and technical oversight for transfer, validation, and execution for PK assays at CROs
• Oversees outsourced bioanalytical phases of studies under GLP/GCP
• Ensures data integrity and regulatory alignment with study protocols
• Monitors assay performance and drives troubleshooting and continuous improvement
• Reviews method validation plans, protocols, reports, and reagent qualification/bridging
• Collaborates with CROs and internal SMEs to understand PK method attributes
• Supports regulatory activities

Skills

PK assay development

Validation

Troubleshooting

CRO collaboration

Communication

Education

Doctorate degree

Master’s degree + 2 years

Bachelor’s degree + 4 years

Tools

ELISA

ECL

LC-MS/MS

Ligand-binding assays

Job description

Career Category Scientific 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.

Scientist, Bioanalytical Sciences

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 bioanalytical activities (including pharmacokinetic [PK] and toxicokinetic [TK] analyses) performed by external contract research organizations (CROs), ensuring adherence to validated methods, data integrity standards, and alignment with study protocols and regulatory requirements. The ideal candidate will have a strong background of method development, validation, and troubleshooting in quantitative ligand-binding assays (LBA) and/or LC-MS bioanalysis, combined with excellent communication skills. This role is well suited for scientists who seek to learn more about externalized work and who thrive working with others in a collaborative manner.

Key Responsibilities

• Provides scientific and technical oversight for the transfer, validation, and execution for pharmacokinetic (PK) assays, ensuring adherence to sponsor requirements and current regulatory guidance on bioanalytical assays (e.g. FDA, ICH, EMEA, NMPA)
• Leads the transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS and hybrid methodologies
• Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the PK method 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/bridging 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

Basic Qualifications

• Doctorate degree [and relevant post-doc where applicable] OR Master’s degree and 2 years of regulated commercial scientific laboratory experience OR Bachelor’s degree and 4 years of regulated commercial scientific laboratory experience

Preferred Qualifications

• Demonstrated expertise in PK assay development, validation, and troubleshooting for LBA, LC-MS or hybrid assays
• Knowledgeable on current relevant regulatory guidance/regulations (e.g. FDA, ICH, EMEA, NMPA)
• 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

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.

Salary Range 109,020.15USD -147,497.85 USD

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 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.

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 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