Senior Scientist, Drug Product Technologies

Join Amgen’s mission of serving patients. At Amgen, 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 a 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.

About the role

In this vital role, you will be responsible for late-stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). The Senior Scientist will provide technical leadership and subject matter expertise supporting biologics drug product development, commercialization, and lifecycle management. This role serves as the visual inspection technical expert across manual, semi-automated, and automated inspection platforms, partnering with cross-functional teams to develop robust inspection strategies for pipeline and commercial products. The successful candidate will leverage scientific expertise, data analytics, digital technologies, and emerging AI-enabled capabilities to advance inspection practices and accelerate development activities. The role requires staying ahead of the latest industry and scientific trends to foster innovation and meet future business needs.

This position requires up to 10% travel to domestic and international sites.

Responsibilities

• Serve as the technical subject matter expert (SME) for visual inspection and provide leadership in troubleshooting complex inspection-related issues.
• Perform offline development studies for automated visual inspection (AVI) recipe development and product quality impact assessments for product teams.
• Interface with inspection teams across Amgen manufacturing sites and communicate site capabilities, best practices, and lessons learned.
• Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes.
• Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection, and fill/finish process development in support of product commercialization and lifecycle management.
• Apply basic science/engineering skills and first principles modeling to solve technical problems.
• Perform data analysis using advanced statistical/analytical techniques with proficiency in statistical analysis software.
• Provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Deliver progress reports and presentations to ensure management awareness and engagement of current status, advancement, and future program functional needs.
• Lead cross-site teams to support the above activities and provide recommendations to management.
• Assist in deviation and exception resolution and root cause analysis as needed.
• Coordinate and organize resources needed to complete tasks.
• Operate in a fast-paced, matrixed environment, collaborating with colleagues within Drug Product Technologies (DPT) and cross-functionally to develop and proceduralize lean study designs for process characterization, create and implement tools for data acquisition, analysis, and modeling, and improve operational efficiency.

Qualifications

Basic Qualifications

• Doctorate degree (PhD, PharmD, or MD) with relevant post-doc where applicable, or
• Master’s degree and 3 years of Engineering and/or Operations experience, or
• Bachelor’s degree and 5 years of Engineering and/or Operations experience.

Preferred Qualifications

• PhD with 2 years of industry experience.
• Background in development and manufacturing visual inspection.
• Experience with Knapp studies.
• Experience in packaging and inspection equipment.
• Previous experience in a pharmaceutical inspection background.

Benefits

From competitive benefits to collaborative culture, Amgen supports your professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted, with actual salary varying based on relevant skills, experience, and qualifications. In addition to base salary, Amgen offers a total rewards plan based on eligibility, comprising:

• 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 sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.