Michael Gorman

Biopharm PM Executive
Michael J. Gorman specializes in guiding manufacturing strategy for biopharm programs. He has helped steer and accelerate dozens of CMC programs from preclinical to commercial across a wide spectrum of modalities from the novel to the mature. With 30 years’ experience in the life sciences, he is a recognized leader who brings agile solutions to the dynamic challenges of technology transfer. With a lean mindset, he adds value for clients by bringing a depth of practical knowledge in subjects including NPI, program management, operations management, capital projects, CMC, quality, and regulatory. Michael holds a MS in engineering management from Tufts University and a BS in mechanical engineering from the University of Massachusetts. He is a certified PMP, a certified Lean Six Sigma Black Belt and a certified SAFe 6.0 Agilist. Michael has been an ISPE member since 2002, and is an ISPE ATMP Community of Practice steering committee member.

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Viral Vector Platforms: Intersection of Facility and Program
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Viral Vector Platforms: Intersection of Facility and Program

Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls (CMC); and market strategies. A key enabler to success is establishing a robust yet nimble viral vector manufacturing platform that delivers high-quality product on time...