Development and GMP manufacture of traditional pharmaceutical products.
I fell into it, really, as most of us do. There isn’t exactly a direct career pathway for it. I have a chemistry degree and at one point I applied for a job with a pharma testing lab on the same day that someone had just quit over in the Quality Assurance department. They said, this job is open as of today, would you like that? Of course, I said yes, and I found it to be a very satisfying road and a good fit for me. Plus, these are skills that are highly transferrable, which is always a bonus. It allows one to seek out new options, such as I did in joining DHC.
The last time I was putting my CV together and laboriously filling out the job history I finally realized something important about myself. I’m the type of person who can get bored quickly if I’m doing the same thing over and over. Once I realized that in order to maximize my enjoyment at work I would need interesting and difficult things to keep me engaged and learning, the concept of a consultant role jumped to mind. In addition to the variability that is built into consulting relationships, I knew Dark Horse wouldn’t be the place for simple, easy engagements. Finally—a position that would never run out of challenges!
I’ve been bowled over by how giving of their time all my colleagues are. They’re incredibly busy, yet they’re always able to make time to answer any questions I may have or point me in the right direction. It’s been an excellent first impression.
In my experience, the difficult thing with quality isn’t with the process of following an SOP – that’s straightforward. Instead, it’s about the mindset, which is a discipline. It takes practice to perpetually be pulling processes apart and examining them. It can feel to someone unpracticed with Quality work as if we’re expecting mistakes, or expecting people to do their job poorly, but that’s not what’s happening.
Instead, we’re breaking down the different systems inherent in processes, doing flow mapping, and building awareness of how each step interacts with the others. In the process of doing that you can identify the risky bits, and then work with the people directly involved in the processes to identify ways of mitigating those risks.
Quality people like to emphasis the importance of communication, and we nurture that skill, because often you’re having to make a case to someone who may not understand the details of the processes, or someone whose priorities (cost, for example, or time) may feel opposed to the requirements coming from the quality group. If we’re able to express ourselves well, we can address those assumptions and identify ways in which an early emphasis on quality is likely to ultimately save both time and money.
In all of these cases there will eventually be a regulatory requirement to maintain a robust quality program, so getting that seed of intent planted early is important. Sooner or later each developer is going to need to hire someone as their quality person, and if processes are designed with some level of quality oversight, then that person will be able to bolster and support the processes from their first day.
The earlier I’m able to enter a conversation to help set things up, the more efficient I can be. The more efficient I can be, the more therapies I can support and the more patients I can ultimately help. That’s my preference, as you would expect!
It’s an odd mix. In my personal life I don’t think of myself as having the explicit fixation on rules and regulations that you might expect from one of us, but if I’m cooking something, for instance, I always follow the recipe and do each step in order. That said, I’ve so far managed to avoid signing and dating any mistakes I make in my writing outside of work!
Yes! Gene (ha! pun not intended) Wolfe has written a ton of fairly complicated novels and short stories, the kind where you really have to pay attention and engage your brain while you’re reading. It engages something of the same mental muscle that I use when I pull apart the details in processes at work. Wolfe was an interesting man—apparently, he was an engineer before he became an author and he’s the person who invented the machine that puts the crimps in Pringles® potato chips. Legend has it that he is the man with the mustache on the Pringles can! (See image below!)
We have two dogs, Jinx (a lab/shepherd mix) and Charm (a bit of a mystery mix) and I walk them every day for at least an hour, allowing me time to listen to music and podcasts—I’m a history buff—and just sort of zone out.
Luckily, I hold dual citizenship: Australian and American, which can make travel a little bit easier. My father is American (from Texas) but he moved to Australia in his 20s and that’s where he met my mother. I was born in Australia (Melbourne) and we moved to Tokyo when I was quite young. We moved back to Sydney a few years later, so other than that one big adventure, I grew up in Sydney. I went to university in Australia also and had my first job there. During that time, I traveled a lot in SE Asia: Thailand, Singapore, Vietnam. I’ve traveled on the Trans-Siberian Express train and been through rural China, Mongolia, and rural Russia – all the way through to St. Petersburg. I was able to prioritize traveling early on in my life and once you’ve developed that travel bug it doesn’t really ever go away.
As a young adult I moved to the U.S. (specifically, to Houston), which is where I met my wife. (My father and I have set up a pattern, apparently!) My wife and I currently reside in the UK, along with our two dogs, of course.
Most overwhelmingly I would say it’s the sense of universalism, the shared experience of humanity. The more I travel the more I realize there isn’t anything truly “foreign,” though there may be experiences that aren’t yet familiar to us. At their core, people are the same everywhere and I find that heartening.
We had many great shots of David + dogs from which to choose…this shot won due to the calming and cozy feeling it provides. It’s an idyllic place for reading an e-book, right?