Celeste Frankenfeld Lamm

Merck & Co Inc
Senior Director, Global Regulatory Affairs-CMC
Celeste Frankenfeld Lamm is a senior director of Global Regulatory Affairs – CMC at Merck and leads the CMC Technical Advocacy and Policy team. In this capacity she is responsible for sharing policy updates, facilitating cross-functional proposals to address regulatory challenges, and external engagement. She has experience with regulatory strategy, engagement with regulatory authorities, and preparation of both clinical and marketing applications. In previous roles within the company, she led analytical development efforts to support both drug substance and formulation development. Her areas of focus include implementation of pharmaceutical innovation including advanced manufacturing, digital technology, and regulatory convergence. Lamm holds a B.A. in Chemistry and Biology from Greenville University, and a Ph.D. in Pharmaceutical Chemistry from the University of Kansas. She currently serves as co-chair of the ISPE Product Quality Lifecycle Implementation (PQLI)® committee, is a member of the PQLI Transportable/Point of Care technical team, and is a member of the ISPE Regulatory Steering Council.

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