# From the Graveyard Shift to the Frontier of Cell Therapy, with Mike Ruane

Page: https://stenobird.com/podcast/let-s-talk-quality-6567110/from-the-graveyard-shift-to-the-frontier-of-cell-therapy-with-mike-ruane
Text version: https://stenobird.com/podcast/let-s-talk-quality-6567110/from-the-graveyard-shift-to-the-frontier-of-cell-therapy-with-mike-ruane.md
Podcast: [Let's Talk Quality](https://stenobird.com/podcast/let-s-talk-quality-6567110)
Published: 2026-04-21T12:00:00+00:00
Episode link: https://rx-group.io/captivate-podcast/from-the-graveyard-shift-to-the-frontier-of-cell-therapy-with-mike-ruane
Audio file: https://episodes.captivate.fm/episode/fcbb895a-29fd-47be-9249-3287a8daba92.mp3
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JSON: https://stenobird.com/v1/public/podcasts/let-s-talk-quality-6567110/episodes/from-the-graveyard-shift-to-the-frontier-of-cell-therapy-with-mike-ruane
Duration seconds: 2126

## Resource

From a graveyard shift in a generic drug lab to leading quality for one of the most advanced cell therapy programs on the planet - Mike Ruane's story is one every quality professional needs to hear. In today's episode I was joined by Mike Ruane, Head of Quality for In Vivo CAR-T at Bristol Myers Squibb. I really wanted to speak to Mike because his career is one of the more fascinating journeys I have come across in quality leadership. He has spent nearly two decades within what is effectively the same organisation, yet has lived through multiple acquisitions, spin-offs and complete pivots in therapeutic modality - each time emerging in a stronger, more interesting role than before. Mike began his career at APP Pharmaceuticals on a midnight QC shift, testing in-process samples on a graveyard schedule. From there, he followed the Abraxane asset into aBraxis Bioscience, built out supplier quality relationships across Central and South America, and eventually relocated from Chicago to New Jersey when Celgene consolidated its operations. That move opened the door to something entirely new - a CAR-T therapy program called BB2121 - a field Mike had never worked in and knew little about. Eight years later, he is now heading quality for in vivo CAR-T, one of the most cutting-edge modalities in all of biopharma. What makes Mike Ruane such a compelling guest is not just the breadth of his experience but his philosophy. He is a first-principles thinker who has thrived precisely because he never assumed the existing process was the right one. He asks the uncomfortable questions, encourages his team to do the same, and believes deeply that curiosity is the most underrated skill in quality. We talk about the following: How working in a lean generic drug environment early in his caree…

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