Work In Process (a bpmd podcast)
Jul 28, 2026 · 27 min · 12 segments
In this episode, Liam O’Neill speaks with Mike Lucas, Business Process Excellence Manager at Alkermes, a global biopharmaceutical company headquartered in Dublin with significant operations in the…
Mike LucasGuest
Liam O'NeillHostSam LewisHost
Yeah, I mean, if there's two places where you don't want things to go wrong, it's when you're 10,000 feet in the air or when you're popping pills at a bedside.

I always struggle with flying as it is, and I, I do a lot of it with my role, and I was always kind of want to say, "Oh, do you know, I want to get in the plane first, get up near the front, because I think that's the best." And then someone explained to me, "No, actually, that's the worst part to sit in the plane.

The best is down the back because you never see a plane reverse into a mountain." [laughs]

So in terms of kind of being in that regulated environment, obviously now you're in Alkermes, and I think you've started a bit close to the shop floor, right? So what were some of the kind of practical things you saw that, you know, prove that this is a heavily regulated environment? We're gonna take this really serious.

When you get into the pharma industry, when I first started in what was Elan at the time, now Alkermes, I was in the biopharmaceuticals, so it was the sterile injectables.

So, you know, there's nothing more to push home the importance of a process than you know that this product is going directly into the veins of someone to help, you know, save their life, you know? So that really kind of honed it in for me how important, you know, the industry is.

And that's why really when I was in there, okay, I was good at my job in manufacturing, but I think there was other opportunities for me in there, and they saw that with me 'cause I was always trying to wonder, "Well, why is this working like this, or why is it not working?" Every time in an issue, I wanted to try and figure out what's going wrong here, what's the logical steps that have failed, you know, the fail-safe, and that's where I kind of got into my Lean sort of Six Sigma kind of frame of mind, you know? Um, taught me there's a gap between processes document and the actual process system because you have your SOPs and it's tenure.

This is the actual day-to-day, how it's used is the most important part of it, you know.

Because SOPs are great to learn, but sometimes not very practical, so business process is, is key, you know, for that industry anyways, I believe, you know.

There's a big difference between writing something on paper and then getting everyone across several countries doing the same thing.

And do you have any real examples of kind of where you saw that, the difference between how it's done and how it's actually done?

You know, have the details, you have to set your weights, your balances this much, you know, you do this amount of product in there.

One of the key parts of where I was in the sterile environment was cleaning the lines, steaming the lines, steam in place.

Yeah, I mean, if there's two places where you don't want things to go wrong, it's when you're 10,000 feet in the air or when you're popping pills at a bedside.

I always struggle with flying as it is, and I, I do a lot of it with my role, and I was always kind of want to say, "Oh, do you know, I want to get in the plane first, get up near the front, because I think that's the best." And then someone explained to me, "No, actually, that's the worst part to sit in the plane.

The best is down the back because you never see a plane reverse into a mountain." [laughs]

So in terms of kind of being in that regulated environment, obviously now you're in Alkermes, and I think you've started a bit close to the shop floor, right? So what were some of the kind of practical things you saw that, you know, prove that this is a heavily regulated environment? We're gonna take this really serious.

When you get into the pharma industry, when I first started in what was Elan at the time, now Alkermes, I was in the biopharmaceuticals, so it was the sterile injectables.

So, you know, there's nothing more to push home the importance of a process than you know that this product is going directly into the veins of someone to help, you know, save their life, you know? So that really kind of honed it in for me how important, you know, the industry is.

And that's why really when I was in there, okay, I was good at my job in manufacturing, but I think there was other opportunities for me in there, and they saw that with me 'cause I was always trying to wonder, "Well, why is this working like this, or why is it not working?" Every time in an issue, I wanted to try and figure out what's going wrong here, what's the logical steps that have failed, you know, the fail-safe, and that's where I kind of got into my Lean sort of Six Sigma kind of frame of mind, you know? Um, taught me there's a gap between processes document and the actual process system because you have your SOPs and it's tenure.

This is the actual day-to-day, how it's used is the most important part of it, you know.

Because SOPs are great to learn, but sometimes not very practical, so business process is, is key, you know, for that industry anyways, I believe, you know.

There's a big difference between writing something on paper and then getting everyone across several countries doing the same thing.

And do you have any real examples of kind of where you saw that, the difference between how it's done and how it's actually done?

You know, have the details, you have to set your weights, your balances this much, you know, you do this amount of product in there.

One of the key parts of where I was in the sterile environment was cleaning the lines, steaming the lines, steam in place.
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