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Let's Talk QualityAuthor: Hemish Ilangaratne
Lets Talk Quality is a podcast that seeks to shine a light on quality assurance, a profession that acts as the cornerstone for bringing safer medicine to patients. For life science companies to continue to develop life-saving medicines, a culture of good quality must be driven across the industry, whether that be an early phase gene therapy biotech or a global pharma organisation. This podcast aims to drive that mission forward through inviting industry leaders, experts, and visionaries to share their knowledge, experiences, and strategies for achieving quality excellence. Join us on a journey of discovery as we unravel the importance of quality and its profound impact on businesses and society. Get ready to engage in insightful discussions, gain valuable perspectives, and unlock the secrets to fostering a culture of quality in every aspect of life. Tune in and lets embark on this exciting quality-driven adventure together. Language: en Genres: Business, Careers, Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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From the Graveyard Shift to the Frontier of Cell Therapy, with Mike Ruane
Episode 10
Tuesday, 21 April, 2026
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 career shaped his mindset foreverNavigating multiple acquisitions and spin-offs within a single career arcWhat it takes to step into an entirely new therapeutic modality with no prior experienceWhy curiosity and asking the right questions is the real engine of career growth in qualityHow he interviews candidates and what most people get wrong when they are being interviewedMike Ruane is a thoughtful, pragmatic quality leader who understands how to balance compliance, collaboration and business reality in complex development environments.If you are a quality professional working in an early-stage biotech and trying to build the right systems with limited resources, then this episode is for you.Thank you Mike Ruane for sharing your incredible journey.Hope everyone enjoys the show.
