Whether it’s for heart disease, or depression, the drugs that sustain our health only reach the pharmacist’s shelves after a hugely complex and highly regulated manufacturing process. The making of a drug can involve input from hundreds if not thousands of people, and right at the heart of it all, is the process scientist.
There is a sense that the process scientists – who are the glue that holds together the entire drug manufacturing process – are the unsung heroes of Ireland’s, still thriving, pharmaceutical industry. The key role of process scientists, working as a technical services team within the plant, is to field questions on any aspect of the process, large or small, from any manufacturing section or quarter, right across the site. They are expected to take these questions and to find answers.
The questions might have to do with the raw materials coming into the plant, or to do with the labeling on the drug as it is about to leave the site. Whatever the stage of the process, or the nature of the question, it will be sent to the process scientists at technical services to deal with. It’s an important, challenging role.
Dr Brian Moran, is a process scientist working within the technical services team at the massive Pfizer Grange Castle Biotech plant in Dublin. The €1.8 plant is located on a 90-acre site and is one of the largest biotech plants in the world. The site as a whole is involved in the manufacture of the ‘next generation’ of EMBREL, a drug used to treat osteoporosis and arthritis, and Prevnar 13, a vaccine used against pneumococcal bacteria given to newborn children. Brian works on EMBREL.
The pharmaceutical industry must have a ‘pipeline’ of products constantly coming through. Otherwise, if a drug like EMBREL came ‘off patent’ without a new version being in place, then the ‘generic’ drug manufacturers would make a cheaper version of EMBREL and sell it using its chemical, not its brand name.
In this scenario, Pfizer, the company that produced EMBREL, would lose out.
The real importance, however, of the job of the process engineer is to ensure the integrity of the production process, in order to make safe, and effective drugs – and that applies to every batch of drugs that leaves the plant, without exception. The secondary role is to save money, by providing efficiencies in the production process, and to maximize the return the company makes from its drug pipeline.
Brian, who is from Dungarvan, was inspired to pursue a career in science by his chemistry teacher at St Augustine’s College, Oliver Broderick. “He was very much ‘old school’, but he knew how to connect with the students,” said Brian about his former teacher. “He knew how to make the subject enjoyable. You would get homework, but it was a pleasure to do the homework – almost. It was very much related to real life. He had a real passion for the subject, for the sciences. It certainly did rub off on the majority of the sudents,” recalled Brian.
Such was his influence, said Brian, that all of his siblings went into the general, scientific, medical or healthcare fields. “I have a brother and a sister that are both pharmacists and my little sister is an occupational therapist,” said Brian’. “The one abiding link there is that we all had the same chemistry teacher.”
After his Leaving Certificate in 2000, Brian went to DCU where he signed up for a four year course in Pure and Applied Chemistry (in his first year the course changed its name to Chemical and Pharmaceutical Science). In the summer following his 3rd year at DCU Brian got the opportunity to work in research in the US as part of a r collaboration between DCU and the University of Kansas.
This experience whetted his appetite for further research after his degree, and he moved on to do a PhD in DCU in medicinal chemistry. The doctorate took three and a half years to complete; then it was on to a post-doc. At this point, however, he switched his chosen field to environmental and analytical chemistry. At the same time, he began questioning the logic of trying to secure an academic job.
“Academia is a very difficult area to break in to,” explained Brian. “To make a success of it you have to be young, free and single, to get the international experience, and build up your contacts. Then the opportunities are very limited. I had a young family and I was looking for something more secure. There was more job security and opportunity by getting into the pharma side of things.”
After two and a half years of post-doctoral work, Brian applied for, and secured a job working in technical services at the Elanco plant in Sligo (Elanco is the veterinary wing of Eli Lilly). He had started to build a house in Dundalk, where is wife is from, and had a small daughter. His stayed in Sligo during the working week and came home to his family at the weekend. When a second child came along a few months ago, a boy, there was a strong motivation to get a job ‘back on the east coast’. The job at Pfizer is within commuting distance of Dundalk.
The great thing about working in the pharmaceutical sector, he says, is that it had – at least until a few job loss announcements recently – been largely untouched by the economic crash. Things are still going well in Irish pharma, but the emphasis, he said, is changing in the industry with a general move away from the manufacture of the bulk products – the tablets and chemicals – into synthesizing medicines using biotechnology. This is exactly what is being done at Grange Castle, he said, where products are being grown up using cell lines, and the whole process is more advanced than before.
“Currently I’m looking at all the starting raw materials coming in, making sure that they are all sufficiently pure, doing any testing that needs to be done to make sure that they are all fine, fit for purpose for the product. We are working side by side with the engineers who are looking at the ‘hardware’ side of it.”
The analogy he used was to think of the process at Grange Castle in terms of it being like building a PC. Under this analogy the engineers are looking at the hardware – the computer monitor, the keyboard, the mouse etcetera– while the technical services department (populated by scientists like Brian) looks at what software needs to be put in, what kind of anti-virus programme and what filters.
Brian loves the interaction across the entire Grange Castle site that his job provides. He is also at ease with the responsibility that comes with the position. On the downside, there is a lot of paperwork. He has had to ‘hang up his white coat’ and spends a huge proportion of his work time in front of a PC writing up reports, writing assessments and signing off on things, rather than at the bench.
He would recommend his job to anyone considering a career in science. “In terms of technical services,” said Brian, “you can get in at the boom level and you can go right up to the very top of the whole manufacturing structure. There is always great scope for moving up the line, there are great opportunities.”
This article was first published in the January-February 2014 edition of Science Spin