Data Scientist – Drug Substance Process Development

Career Category

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. 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.

Data Scientist – Drug Substance Process Development

What you will do

Let’s do this. Let’s change the world. In this vital role on the PANDAS team, you will have two main roles: (1) serving as the process monitoring site lead for one of Amgen’s four internal commercial manufacturing sites, and (2) leading efforts to expand and optimize digital capabilities that support clinical and commercial manufacturing. You will develop, evaluate, and enhance data solutions that drive operational excellence across the global manufacturing network. Collaborating with a diverse, cross-functional team of scientists, engineers, and technologists, you will address complex, ambiguous problems where multiple solutions may exist. This role emphasizes architecting scalable data systems and building impactful analytics tools for process monitoring, technology transfer, and commercial manufacturing support, while also contributing to enterprise-level digital initiatives across Process Development.

Process Monitoring (Site Lead)

• Act as the primary point of contact for process monitoring at an assigned commercial manufacturing site.
• Ensure active engagement of site PD teams in the Process Performance and Product Quality Monitoring (PPPQM) framework, integrating analytics to support proactive, data-driven quality oversight.
• Prepare data and author Process Data Analysis sections for Annual Product Reviews for products within the site scope.
• Maintain and revise digital infrastructure as needed to comply with automated process monitoring procedures.
• Calculate control limits, author supporting documentation, re-evaluate limits when required, and ensure monitoring strategies are executed per procedure at the assigned site.

Digital Infrastructure Development

• Design, develop, and maintain digital assets and applications (e.g., Spotfire dashboards, SIMCA models, Databricks pipelines, Product Lifecycle Management tools) that integrate data across systems to deliver meaningful insights.
• Partner with IT and enterprise teams to advocate for data model and pipeline improvements by developing a strong understanding of Amgen’s data architecture, standards, and ontologies.

Analytics & Insights

• Deliver end-to-end analytics solutions—from data ingestion and wrangling to modeling and visualization—to support tech transfer, process monitoring, and commercial manufacturing.
• Support the exploration of emerging technologies, including generative AI, to enhance digital capabilities within Drug Substance Technologies.
• Collaborate cross-functionally with scientists, engineers, IT, and external stakeholders to identify opportunities for process design and operational improvement.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Data Science professional we seek is an individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 8 years of Data Science or Engineering experience; OR
• Associate’s degree and 6 years of Data Science or Engineering experience; Or
• Bachelor’s degree and 2 years of Data Science or Engineering experience; Or
• Master’s degree

Preferred Qualifications:

• 3+ years of work experience in biotechnology role (e.g. process development/process engineering, a statistician, statistical programmer, data analyst, data scientist)
• Demonstrated expertise in process development or commercial manufacturing, with strong proficiency in unit operations and an understanding of common data requirements within the manufacturing domain.
• Proficiency in Python, R, SQL, and cloud-based analytics platforms (e.g., AWS, Snowflake, Databricks).
• Advanced experience with