The non-linear path is often the most powerful one.

Cinta Burgos on Building a Career Across Functions, Modalities, and Mindsets.

In today's episode I was joined by Cinta Burgos, Senior Vice President of Quality and Regulatory CMC at New Amsterdam Pharma.

I really wanted to speak to Cinta because her career does not follow the path you might expect for someone at SVP level. She has moved across pharma, medical devices, and biologics, held roles in quality engineering, validation, regulatory, and consulting, and built her executive presence not through a linear climb but through curiosity, flexibility, and a willingness to take opportunities as they came.

Cinta's journey began with a biophysics degree, a near-completed master's in mechanical engineering, and early laboratory work on human growth factors and the varicella zoster vaccine. Life changed direction more than once - moving across the country, starting a family, building a consulting practice that spanned 17 years - and through each transition, she added a new dimension to her expertise. Today she leads quality assurance, quality control, quality systems, and CMC regulatory at a company she describes as scientifically driven, ethically led, and genuinely exciting.

What stands out about Cinta is her philosophy of leadership. She talks about moving from task-oriented thinking to big-picture ownership, about not micromanaging the talented people around you, and about the importance of keeping a personal board of directors - mentors you check in with at different stages of your career. She is also candid about the moments where she did not immediately see an opportunity for what it was, and honest about what that taught her.

We talk about the following:

- How a biophysics background and an unfinished master's became an asset in a 30-year career

- Why Cinta moved from R&D to validation to quality and what each transition taught her

- The value of 17 years in consulting and the leadership jump it created

- How quality professionals can move from task-oriented contributors to big-picture leaders

- The role of AI in quality and manufacturing, and why human oversight is non-negotiable

- Why quality voices are still largely absent from board-level conversations

- What it means to treat everyone in your company as a quality professional

Cinta Burgos 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 Cinta for sharing your incredible journey.

Hope everyone enjoys the show.

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 forever

Navigating multiple acquisitions and spin-offs within a single career arc

What it takes to step into an entirely new therapeutic modality with no prior experience

Why curiosity and asking the right questions is the real engine of career growth in quality

How he interviews candidates and what most people get wrong when they are being interviewed

Mike 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.

CAR-T Saved Her Life. Why Can’t Most Patients Access It?

In today’s episode I was joined by Laurie Adami, cancer survivor, patient advocate, and one of the most impactful voices I’ve had on the podcast.

I first spoke to Laurie a couple of years ago, and her episode is still one of the most listened to we’ve had.

Laurie went through a 12-year cancer journey, six lines of therapy, multiple relapses, clinical trials… and ultimately, in 2018, her 7th treatment, CAR T-cell therapy which saved her life and finally for the first time in 12 years put her in a complete remission.

Now, two years on, she’s back.

Still in a complete remission and requiring no further treatment nearly 8 years post CAR T infusion, Laurie is now considered cured even though her cancer is still labeled incurable.

But what stood out to me in this conversation is that while the science has progressed… many of the systemic challenges patients face haven’t.

We talk about the following:

· What life actually looks like after being “cured” of cancer

· The long-term side effects of 12 years of treatment

· Why most biotech and pharma professionals have never spoken to a patient

· The reality behind “patient centricity” in the industry

· Why 80% of eligible patients still can’t access CAR-T therapy

· The biggest bottlenecks in access - awareness and insurance

· The financial burden of cancer treatment in the US

· Where real progress is being made in cell and gene therapy

· The future of CAR-T in autoimmune diseases and beyond

· Laurie’s memoir and why every biotech employee should read it

This is an honest conversation about the gap between scientific progress and real-world patient impact.

A huge thank you to Laurie for returning to the show and tell her story again! The work she is doing to help raise awareness is inspiring, and I’d urge anyone to connect with Laurie and follow her journey.

If you work in biotech, pharma, healthcare, or you’d like to learn more about the challenges this industry still faces… this is one you need to hear.