Stephanie Ramsey is a seasoned biopharmaceutical leader with over 24 years of experience in Microbiology, Quality Systems, and Process Development. She currently serves as a Senior Principal Scientist at Amgen, where she leads the Process Microbiology Team within the Process Development organization.

Stephanie’s team plays a strategic role in shaping Amgen’s microbiological attribute monitoring and control strategy. They support troubleshooting of microbiological and compendial method issues across diverse analytical platforms, ensuring robust microbial control. Her group also serves as a centralized hub for evaluating and implementing rapid and alternative microbiological technologies, including rapid sterility testing, the Monocyte Activation Test (MAT), and Growth Direct.

Stephanie led the global method validation of Growth Direct to support its enterprise-wide rollout at Amgen, advancing rapid microbiological methods and modernizing quality control capabilities.