Process Development Senior Principal Scientist

Career Category

Operations

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.

Let’s do this. Let’s change the world. In this vital role you will join our Pivotal Drug Product Technologies group in Thousand Oaks, CA. This group supports drug product commercial formulation development as well as formulation/fill/finish process development for Amgen’s Late-Stage biologics.

The Senior Principal Scientist will provide technical and project leadership while integrating information generated by functionally diverse teams to ensure success through the commercialization process.

The ideal candidate will bring hands‑on experience in ADC drug product formulation and drug product process development, including a mechanistic understanding of linker‑payload attributes, stability/process-relevant degradation pathways, and analytical strategies used to characterize ADC CQAs. This candidate will integrate formulation, analytical, and process data to guide product design, apply cutting‑edge technologies (including AI/ML), and collaborate cross‑functionally to deliver high‑quality, stable, and manufacturable drug products for development in a fast‑paced environment.

• Lead planning, design, execution, and documentation of laboratory studies related to drug product design, formulation, and process development, and tech transfer
• Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs
• Author and review guideline documents, technical protocols, reports, product impact assessments, regulatory submissions, and developing responses to regulatory questions
• Develop and characterize liquid and lyophilized formulations for biologics, with particular emphasis on ADC drug product formulation, handling, and lab‑scale sterile filling.
• Lead internal and external technology transfer activities, including collaboration with CMOs/CDMOs, process fit assessments, and troubleshooting during manufacturing campaigns.
• Apply machine learning, AI, and data science to predictive modeling, workflow acceleration, and decision‑making.
• Serve as a Drug Product Team Lead of a matrixed team to develop strategy in support of commercialization and life cycle management of Amgen’s pipeline
• Manage team of engineers and scientists to advance program and functional objectives
• Work effectively in a highly matrixed team environment to influence and inspire change, efficiency, and foster positive relationships
• Ability to travel domestically and internationally up to 10% of the time

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

• Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience
• Master’s degree and 5 years of Scientific experience
• Bachelor’s degree and 7 years of Scientific experience

• Advanced degree in Engineering, Pharmaceutics, Biotechnology, Material Science or related subject area
• 8+ years…