As a Graduate Process Validation and Business Strategy Co-op at Amgen, I worked in a start-up manufacturing environment and gained experience at the intersection of validation, process engineering, and business strategy. My work supported commercial readiness through PPQ protocol authorship, microbial hold strategy activities, data verification, and cross-functional collaboration across process validation and upstream/downstream engineering. 

Key contributions included authoring Media/Buffer and In-Process Pool Hold Studies, supporting PPQ scoping activities, expanding the scope of a Computational Fluid Dynamics (CFD) study, and building technical and strategic experience in a fast-paced manufacturing setting.