About

Michael Burns is a biotech executive and CMC/Process Development leader with more than two decades of experience guiding advanced therapeutics from preclinical development through commercial launch. He is the Founder & Principal of Luminal Arc Advisory, where he supports emerging and established biotech companies with strategic CMC leadership, manufacturing readiness, and organizational scale‑up.

Michael’s career spans cell and gene therapy, viral vectors, biologics, and other complex modalities. He has held senior roles across the industry, including leadership positions at Amgen supporting the commercialization of T‑VEC (Imlygic®), and at bluebird bio overseeing lentiviral vector–based cell and gene therapy programs, including Lyfgenia® and Abecma®, through late‑stage development and commercial launch. Earlier in his career, he contributed to Therion Biologics’ poxvirus cancer vaccine platform and Shire HGT’s enzyme replacement therapies, Replagal® and Elaprase®.

Across these roles, Michael has built and led high‑performing technical organizations, executed global tech transfers, established manufacturing governance frameworks, and guided companies through regulatory interactions and pivotal readiness. He is known for his ability to translate complex technical challenges into clear strategic pathways, and for helping founders and executives make confident, high‑impact decisions.