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Commentary|Podcasts|October 23, 2026
Building Biopharma Manufacturing for Speed, Scale, and Flexibility
Author(s)Michael Christel, Dave Maraldo, Ph.D.
Dave Maraldo, Ph.D., president of manufacturing at Merck, explains how flexible capacity, earlier input from manufacturing in R&D, and digital tools are helping the organization keep up with a faster, more varied portfolio.
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Biopharma manufacturing today is being asked to move faster, accommodate increasingly complex modalities, and respond more readily to changing development timelines and demand forecasts — all while maintaining reliable, compliant, and cost-effective supply.
In this episode of the Pharm Exec Podcast, Dave Maraldo, Ph.D., executive vice president and president of the Merck Manufacturing Division, draws on 27 years at the company to explore that evolution. He discusses Merck’s major U.S. capacity investments; its approach to balancing internal capabilities with strategic manufacturing partners; and the closer integration of research, development, and production.
Joining Mike Christel, group managing editor, MJH Life Sciences, in studio, Maraldo also examines the practical impact of digital tools and artificial intelligence and how Merck is building greater agility and resilience into its global supply network. He reflects ahead as well on what the next generation of manufacturing talent will require and why he thinks patient needs will move closer and closer to the shop floor.
Conversation highlights include:
- Why manufacturing must now deliver real-time adaptability, not simply remain “off the critical path.”
- How Merck evaluates core technologies, flexible capacity, and external partnerships amid growing pipeline and demand uncertainty.
- Where digital tools, advanced analytics, and AI are generating practical gains in production, technology transfer, and regulatory authorship.
- Why tomorrow’s manufacturing workforce will need a hybrid of scientific, engineering, critical-thinking, and digital capabilities.
Click below to listen to the audio version and subscribe to the Pharmaceutical Executive Podcast:
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