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If you want to know how to scale big without losing control, my guest today is for you, Cyril Keller Halls, now COO at Adeline, turned FDA failure at Novartis into success, scaled 34 million dollar operations and even led the 200 million dollar build of a biofuel farm giant.

And today he's going to share his playbook for leaders who need to grow under pressure.

Cyril, welcome to lead the team, my friend.

Good morning, Ben.

How are you doing, man?

I'm doing well.

It is so good to have you with us today.

So what's it like to face down the FDA after a failed inspection?

You know, it is part of normal business when you're in a quality role.

Health authority orders, independent fda, Health Canada, they're all part of your regular routine.

So having an inspection inspection is not the end of the world.

There's a common say before, after the inspection is before the inspection.

So you have to be ready all the time.

But going back to that specific example, it was definitely not pleasant to get the 483, which is a, which is the FDA form with all the observations of everything which is not good or has to be improved.

And it is really important to start with the quality mindset, with the quality culture.

So it starts with the leader, starts the leadership, and then you have to really go through the different items.

And what often is done wrong is that people look just in one dimension.

So they have this blind spot.

They just think, oh, I need to fix a.

But a health authority like FDA or Health Canada is looking always okay, what else besides a.

You have to think about horizontal and also vertical.

But at the end of the day, it starts with leadership, it starts with culture and it starts with the person in charge.

Because if you don't walk the talk, you will fail as well.

So the quality mindset starts at the top.

And in healthcare, my gosh, we need that.

Oh, absolutely.

First of all, when it sounds like in this business, when there is an FDA failure, do people freak out or they're like, hey, we have the systems in place to address this.

It's a chance for us to get better.

How do people respond?

I think it's about both.

I think people which freak out are the people which don't know the details.

And you know, when you go on LinkedIn or in all the social media, see all the stuff which is not good in the pharmaceutical industry and you start seeing a narrative which is based on just sound bites.

And by the end of the day, each company, small or large, will keep their 483 or their, their responses kind of tight because you don't want to share the dirty laundry.

And the bits and pieces which goes out in the public will create their own narrative.

So yes, it will create drama, it will create stress, but at the end of the day, you always can fix it.

It's always a question of time, energy, money and, you know, willingness to do it.

So you have addressed this multiple times.

Where there's a failure or there's a problem, you come around, you come in and you fix it, so to speak.

Right.

Coo.

Fix it.

Fix it.

Yeah.

In that case, what are you doing to change the mindset?

Or do you like.

Do you start with mindset?

Do you start with tactics?

Do you start with an investigation?

What's your playbook for coming in in a difficult situation and making a change?

Honestly, it's all above.

It starts with mindset, it starts with tactics.

It's starting to understand what is the true root cause.

When you have a lot of overdue kappas and deviations, you can say maybe your quality management system is not good, but maybe you have also not enough resources.

So again, you cannot just go in one direction, you have to go multiple direction.

But in, in the cases which I had the opportunity to turn around is really be tactical.

I know it's not, it's not sexy to as a side head or head of quality, you know, go in the nitty gritty.

But at the end of the day, you need to go on the shop floor, you need to talk to the people.

It's all hands on deck.

So that's my style.

I, I always say this, my, this office in, in Ohio and with underlying bioscience is the loneliest office because most people don't like to call my office because it's always about challenges.

At the end of the day I have to go out, I need to know, hey guys, what's going on?

And it's not a bad thing.

What I remember in that specific situation, I started talking to the people and people were afraid.

What does the vice president of quality come around and talk to me?

And it's not about that.

I'm looking for stuff.

I want to know how I can help you because as a leader and you can go on all the different books about servant leadership, et cetera, at the end of the day, leadership is about basics.

Talk to people, listen to people, and then whatever they tell you, act on it.

And even the answer is sometimes, no, I cannot do it because ABC give a feedback.

So in that case, we went Started going through the nitty gritty.

We started tactical.

You had the meetings.

It's really.

You are kind of a PM and you drive the organization.

What is important.

Whatever you do from a quality standpoint, you have always a partner in crime engineering, validation, manufacturing.

So you cannot do it by yourself.

You need to get the buying from the rest of the organization, going back to communication, collaboration, etc.

So we fixed it, we turned it around, we had that specific site, had a reinspection and the auditor walked away with no.

43, which was a significant improvement.

And again, I wouldn't say it was me, it was my organization, was everybody, which was part of the organization which drove us to the next level.

Love that.

The message I'm hearing is when there's a big problem, leaders don't solve it from the ivory tower.

Oh, absolutely not.

This is.

He cannot do it.

And I personally get on the floor.

Get on the floor with the people.

Don't try to, don't try to fix the problem from the spreadsheet.

Get on the floor with the people who are actually doing the work.

I personally think the higher up you are, the lower you're on the food chain.

I'm.

When you, you know, you have your classical org chart and the CEO or the president on the top and then whoever that below, I think you need to turn it around.

I think the higher up you are, the less important you are really for the organization because you don't touch product, you don't make the, the nitty gritty decision.

You don't clean the clean room floor.

The staff does it.

And it's really all about servant leadership.

Well, and so looking back at that, you guys had success.

You, you turned it around.

Is it like, did you feel like the will stayed on the bus, they kept making progress after you left and got promoted and moved up.

Did.

Were those leaders able to step up and maintain that level?

We did unfortunately or fortunately, depends how you look, that part of the organization went through a transition, got acquired by somebody else.

And the challenge was really we in the leadership team, we felt integration, we felt the change and we had all these integration meetings, but we never really translated this new culture down to the shop floor, which if you don't, and I think this is the other lessons learned throughout my career.

If you don't actively drive a culture or influence the culture, it will start driving itself and normally not in the direction you want to do.

So what happens if you don't drive it?

People again, start their own narrative and start, you know, looking for New opportunities and depends where your facility is.

There's a lot of competition normally for highly talented, you know, operating analysts, especially.

After they'd righted the ship.

Right.

They had had some big wins, you guys had built your brand on turnarounds.

And other people start saying, hey, those Novartis guys know what they're doing, maybe we need to hire them away.

Meanwhile, you're being acquired by an entity who may not know about all the details here.

Yeah.

And the main challenge was that entity was, had a different culture, was a European entity and decide which turned around, was us based.

And you know, yes, we all have a common base around culture, etc.

But at the end of the day, there's still a cultural difference.

And I grew up in Switzerland, so I kind of know there's differences.

And again, if you do, don't do a culture change or a change management, not a technical change management.

You need to do a change management for the people.

And I started, I remember I started losing the first person for what?

For a stupid reason.

He had to go back to, to help his parents.

And then I had, after a while, I had every week two resignations for my organization.

My organization.

I had 150 people.

So I lost, I think over four or five months, 30 or 40 folks.

And this is really when I realized, you know, yes, we had a great audit, we had a lot of great things, but there's something else I missed.

So I started doing, having stay discussions.

I had skip level meeting again, going back to what was needed from a technical standpoint.

I had to do the same for the people part.

Being on the shop floor, interact with them, don't send an email, walk over there with, you know, it's, we always laugh, you know, email is so convenient.

Or, you know, zoom meetings.

But at the end of the day, the personal interaction, the five seconds, hey, how was your week?

And did you see the sports game?

Makes a difference.

Because when at the end of the day you can have the best facility, the best technology, if you don't have the people which help you to drive it, you will fail as an organization.

Yeah, it's.

It's so interesting.

Almost like a victim of your own success in that point, you built a great team.

You guys had wins and you were acquired.

Right.

An external organization identified, you know, you, your team, your broader organization as, hey, they're a good investment.

Yeah.

And you had, before we started recording, you started talking about this iceberg idea about, on the surface, the iceberg, you know, it looks great, it looks small, it's going to be easy.

We're a European entity, we're going to acquire this US success machine.

But then you get below the surface and there turns out to be a lot more to it.

And you mentioned a few mistakes that leaders making those situations.

Yeah, yeah, sorry, go ahead.

No, I think the biggest mistake is you is that that only the change manage part of this transaction or this investment was completely missed.

You know, the new owner had a different model language in the first place.

They had a different lifestyle there.

You know, everything was more.

Yeah, it's just everything was different and we could never translate that.

And then during the initial phase, you know, again, leadership team had fancy trips to the headquarter and you know, we shared a little bit but stuff but at the end of the day we couldn't translate.

And then again as people started leaving and then some key leaders started leaving and you know, oh, what does Peter know?

Which I don't know.

And you know, the whole narrative starts.

Who hasn't been there.

Yes, I know.

And this is, you know, if I can go back, I would.

And there are definitely things in my life I will change.

I think every day I walk home or drive home, say, okay, this was a good day, but this, I should change that for next time because there's always something you can do better.

As a leader, you never stop learning.

I think this is the other lessons learned.

You can read every book, it never stops.

But there's definitely things that if I could go back, I would do things differently.

Wow.

Well, thank you for sharing that raw story with us because, you know, you're helping us also grow as leaders.

And I just love your honesty here about, hey, we had all this success, we hung our hat on it and then we weren't perfect.

At the end of the day, eventually, you know, things change externally and leaders sometimes have to navigate not just the internal challenges, but the external ones.

Oh, absolutely.

So, so good.

Now fast forward.

You're up to some really big things.

I mean really taking a piece of land at Adeline and constructing a biopharma giant $200 million build on that land.

I mean it just seems, it just seems really impressive.

So how do you scale to 200 million a $200 million facility without losing control as a, as a COO, you.

Know, it is, I have to say this is or is or was an amazing journey.

So when I started with Andalin in May 2021, they just finished up putting the last piece of steel in the ground.

From there, we really had the race to finish up the building and we started production year and a half later and it's again, it goes back to collaboration because I was during that time just the manufacturing guy and now I'm the coo.

So in a different position but at the end of the day it is, you need to bring the people and communication, collaborations.

Because I remember when we started activities here, the office building was not done so everybody in operation was sitting on Costco chairs in the warehouse because the rest of the office track was not built out.

And it goes back to, you know, I was worried will people love it or hate it?

At the end of the day they loved it.

And it goes back about mindset.

And for us, I think where it's really, I think a big differentiator is the purpose.

We, we create as Andalin, we create for, for other companies, their products and it's all about cell and gene therapy and, and we often can name the patient.

We know there's, we produce that product and it's about purpose and it's about leadership and you know, it's.

Yeah, yeah, I love that.

It reminds me of that classic metaphor about someone walking down the road and there are these three guys like breaking bricks or stacking bricks.

And it comes, the first one and he's like, hey, I'm sitting here all day, what are you doing?

It's like, I'm sitting here all day, I'm just, I'm just stacking bricks or stacking, stacking stones.

And the guy thinks himself, that doesn't sound like much fun.

And the guy's sweating, he's sad.

He goes, the next guy who's doing the exact same thing and he says, hey, what are you doing?

He's like, hey, I'm building this wall.

This wall is going to be big, it's going to be tall.

And his spirit seemed to be uplifted a little bit more than he wanted.

The third guy, he's like, what are you doing?

He looks like he's doing the same thing as the other two guys, but he's not stacking stones or building a wall, he's building a cathedral.

And suddenly the purpose is bigger.

And when I think about Adeline and what you're doing as a coo, instilling this mindset to your people of hey, we're not just building a 200 million dollar building, we're building a place for gene therapy, for patients, to save lives.

Absolutely.

And I think at the end of the day, going back throughout my career, I think the purpose of a company is personally for me the biggest decision if I join a company or not but that because at the end of the day you have the money is all the same, you know, let's be honest, more or less, you know and you have the same perks on or not.

But if you have a different purpose, vision and mission of a company I think makes a difference if you join a company or if I'm joining a company.

And I know a lot of the of my staffs coming to us because they know that the people which we support, you know it's for them life changing and most of the patients that got our treatments, their children.

We had a case where the girl was 12 months old and when she got treated 10 months later, you know we changed hopefully her life and she was, it's her name is Ellie and Ellie's team, we produce for them and that's it's publicly announced and Ellie is, has an ultra red disease.

There are just 150 children on this planet with this neurological disorder which impact her, you know, her life and you know and, and it's so we produce for that and we had last year the opportunity to, to have Ellie on site.

You know it's, it's, it's just these.

Yeah it's just on site.

You're she, she's like the employees are seeing her, the people we.

So it was a golf outing and we had her you know close.

So it was really the, it was really mind blowing.

And Andelyn, the name is from Andrew and Evelyn.

So both were treated by or by Dr. Mandel with products which Nationwide Children's Hospital produced many years ago and Andalyn Everlin, they're coming ever so often to on site.

So my staff, the Andalin staff knows Stem, you know they can say hi, they can talk to them.

So going back to purpose as a leader is I think the ultimate weapon to, to to get a strategic plan and objective and execute it at the end of the day.

Yeah.

So good.

I got a reminder like the trying to help your team keep that front and center.

A lot of leaders might be thinking well my company's making widgets.

We're not making gene therapy for 12 month olds to save their life.

Right.

But you've got to find, you got to find the equivalent.

Right.

Find a different purpose for your organization.

And I love this because even, even at Adeline, like even with your, your team, you it's so easy to get Meyer down into the spreadsheet.

Oh absolutely.

Forget just start to forget the other stories of Like Ellie.

And then we, as a leader, like we've got to remind people, don't we?

Absolutely.

And you know, I'm normally here to early in the morning and leave late at night.

And I'm in PowerPoint and Excel file.

I'm, I'm, I'm not without fault, but again, talking about this kind of situation, the alleys of the world, and there's, I saw a study, there's 7,000 rare and ultra rare diseases out there and for most, nobody is creating any kind of cure because at the end of the day, big pharma want to make money.

And rare and old rare diseases, you don't make money.

So you make it maybe because you, you know, you think it's the right thing to do.

But everybody is focusing these days on GLP1s, et cetera, because that's the cash call.

You don't care about the alleys of.

The world, but lose weight is much more exciting than okay, 100 people have this.

It's.

Yeah.

Versus a million people.

Exactly.

So it's.

But you're right, I think every company has, as a, has a purpose and sometimes it's, we're just too close to see how it can impact.

Man, what a doozy today.

Sir, round of applause from the crowd to Cyril.

Where do you want to take this last one?

Like what?

Maybe a story you want to tell or a message that, or a question I didn't get to that you'd like to answer.

But what's something that you want to leave the listeners today?

You know, I think or I believe as a leader, you have to be, you know, a servant leadership.

You have to take care of your people because at the end of the day, if you don't do that, you will fail as a leader.

You cannot, I cannot do anything my staff can do.

And they're experts, always experts.

So as a leader, trust your staff, empower them, protect them, be their ally in the good and the bad days because they make the difference.

Yeah, what, what a great message.

And I think leaders watching this know, Cyril, that you've, you got the scars to prove it.

Right?

You've been on the winning side.

You've done big turnarounds, you've been in situations where you've got other challenges and lost team members.

And you're even in the place now where at this intersection of all, all that coming together for really almost like a higher purpose with like this gene therapy facility, 200 million dollar facility.

And you guys are up to really, really big things.

Thank you for coming on the show today.

Cyril, great job.

My pleasure.

Thank you.