Process Development Sr Scientist - Thousand Oaks CA

Process Development Senior Scientist

Let's do this. Let's change the world. In this vital role you will support Amgen's diverse early-stage therapeutic portfolio by characterizing process and product properties of large-molecule drug candidates and assessing quality attributes of protein therapeutics across multiple pipeline areas. This role will provide analytical leadership for pre-pivotal programs and apply advanced analytical techniques to characterize novel modalities in development.

Serves effectively as the Attribute Sciences representative on cross-functional project teams and collaborates effectively with scientists across multidisciplinary teams.

Designs experiments to build a fundamental understanding of therapeutic protein attributes and stability characteristics.

Applies advanced technical expertise in analytical methods to characterize protein therapeutics, including CE, SEC, IEX, RP, HILIC, and mass spectrometry, with strong understanding of the theoretical and practical aspects of stability-indicating assays, including design, performance, and data interpretation.

Evaluates analytical method performance and reliability, including the impact of proposed method changes.

Demonstrates deep understanding of product quality attributes, analytical approaches used to measure them, and strategies to ensure appropriate control.

Supports drug substance and drug product process development, protein characterization, analytical data generation for regulatory submissions, and technology transfer activities.

Authors regulatory documents and applies understanding of regulatory expectations for analytical methods, control strategies, stability strategies, and comparability.

Stays current in the field and evaluates emerging analytical technologies.