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Manufacture Dosage Forms, Formulation, Facilities, Analytical Science, Small Molecules, Quality & Compliance

The Forensic Troubleshooter

If you weren’t a scientist, what would you be?

When I was at school, I toyed with the idea of being a comedy actor! But throughout my career, people have told me that I would have been a good teacher. I’m not sure I would personally have chosen a teaching career, but perhaps it would have chosen me if I hadn’t focused on science.

I chose to study chemistry and analytical science at university. For a time, I had wanted to be a policeman, but I decided to fight crime in a different way by becoming a forensic scientist. After I graduated, however, I found that I couldn’t really afford to leave home and survive on the starting salary of a forensic scientist. I’d like to believe that the forensic science industry lost out on a great scientist that day and they really should review their starting salaries…

Instead, I decided on a career in water analysis. I went to an interview in Swindon, UK. Next door, there was also a job in quality control going at RP Scherer and I ended up taking the QC job.. Actually, it all turned out rather well!

And how was your first foray into the industry?

At the time, the company wanted a graduate with a fresh perspective to look at their testing laboratory and solve some of the problems they were experiencing with ageing methods. That really suited me because I liked mysteries and solving problems (hence my original forensic interest!). However, I didn’t enjoy QC all that much. Ultimately, a lot of the problems went back to people, and although I made friends in high places by solving problems, I also made a few enemies on the bench. The work was also too repetitive and it wasn’t the place for me. But then I had the opportunity to move into process development – where there were more mysteries to solve. The company had recently moved from one facility to another, and could not get some of the batches to run correctly despite using the same equipment. In manufacturing, people were really keen to get those batches made so there was enormous support from those around me. After a 2-3 years, it felt like we’d solved nearly all of the problems in manufacturing, but we could not prevent new ones being created…

After manufacturing, I moved to a formulation role. This gave me further opportunity to grow and learn, and over the next few years I spent less energy fixing issues, and more energy on putting in place a “right-first-time” methodology.

What are your proudest achievements?

At Catalent’s Somerset site in New Jersey, we commercialized several products. It was crucial to be able to flag up potential manufacturing issues early enough for them to be fixed before validating the process – I’m proud of the part that I played in fixing any possible problems before they affected the business.

Over the last few years, I have been asked to write chapters on soft capsules for several publications, including the Encyclopedia of Pharmaceutical Technology and Aulton’s Pharmaceutical Sciences, which are used to educate students and others. Aulton was the same book that I was given as a student to learn about the pharmaceutics part of my course!  It was really nice to be recognized as an expert in the field and to give something back to the next generation.

You’ve also been involved with the US Pharmacopeia...

I was on an advisory panel. The more I thought about it, the more I realized that it was a terrific thing to get involved with. After monographs are drafted, they are released for people to comment on; if you’re not paying attention, it’s easy to miss the review window and then you have to live with the consequences of what was finally published.

Sometimes, even when people think there is a better way of doing something, no one wants to change – finding a new solution is extra work.

Catalent makes more than 7,000 products, and I’d say there have been instances when we should have had a seat at the table when it came to monograph negotiations. People from smaller companies (and making significantly fewer products) were influencing monographs that affected our work. I stepped up to try and correct the imbalance – and it was a fantastic experience. If you're prepared to roll your sleeves up and get involved, you can make a difference. But you can’t just think about your own company; you need to think about what is best for the industry overall.

I was able to connect with some great people too and, in time, I was invited to give a presentation to the US Pharmacopeia and the FDA about Catalent’s technology and expertise.

Why is it so valuable to gain experience outside of your own company?

Two things are important in development. One of them is diversity of thought; getting as many different opinions about a project on the table as possible – and preferably at the beginning. If you come across unforeseen issues later on in a project, I believe it proves there wasn’t enough diversity of thought early on.

The second is being able to define a continuous strategy to deliver projects successfully. Working outside your own company gives you both diversity of opinion and a better sense of when you have the right strategy.

Sometimes, even when people think there is a better way of doing something, no one wants to change – finding a new solution is extra work. But if you have other experiences you can draw on, you can show the benefits of the future state: “I’ve seen how other companies approach this problem. Let’s try it this way…”

All that said, you don’t necessarily need to move companies to gain diversity of thought, especially in a larger company like Catalent. My advice is to talk to people – both inside and outside your own department, unit or company. There is turnover in any company and there are always new people. Invite them for a coffee. Ask them about their job and what they did before. There is always an opportunity to share common experiences and maybe learn something new that will help you in the future.

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