In association with BioMarin International Ltd
As 2018 winds to a close, BioMarin International Ltd is looking to the future with great confidence and excitement, particularly given the recently announced investment in a new Drug Product Filling Project at its Shanbally, Co Cork, facility.
The project will allow the company to maximise the flexibility of the site with the expansion of the operational manufacturing capacity to meet the rise in the global demand for its therapies to treat rare genetic diseases that mostly affect children.
At an estimated cost of approximately €38 million, the completed facility will bring the workforce to more than 400 people at Shanbally.
Fifty-one new roles are expected to be created across all disciplines, and there will also be up to 100 additional personnel on site during the construction, commissioning and qualification phases.
“It is another tremendous part of the BioMarin story in Cork and Ireland, particularly for those of us who have been here since 2011,” says Michael O’Donnell, Vice President of Operations and Site Leader at Shanbally.
“It gives us an ‘all things under one roof’ capability, to be able to produce, package and label our products, and certainly presents a strategic advantage here in Cork.”
The introduction of fill-finish capacity at Shanbally provides for fully integrated manufacturing from bulk to drug product onsite, and continues the ongoing expansion and growth across the company’s seven years of operations at Shanbally.
In 2016, BioMarin extended its site footprint to 20 acres, as the company continued to experience a rise in the global demand for its therapies.
That phase of development included an expanded warehouse, new European administration offices and utilities, a canteen and conference facilities — all of which allowed BioMarin to maximise the flexibility of the site.
In addition, 2014 saw the company expand its Dublin operation, with the creation of 50 new jobs in its European Commercial Operations Hub.
The Dublin office has responsibility for international commercial operations, contract manufacturing support, finance, legal and compliance.
“In the same way that sporting teams experience ‘purple patches’ of perfect play, we at BioMarin have certainly experienced a wonderful recent period of growth.
"The company is growing constantly all around us, and while we are occupied with new products and procedures, the site continues to expand to accommodate the demand of the marketplace.
"It really is a wonderful time for all of us who work here,” he adds.
“All of us at BioMarin are constantly reminded of the patients we serve, and because of the specialised rare disease and orphan medicine space we operate in, we take huge pride in the work we do and the positive difference we can make.
"The focus on patients resonates very strongly with the team here, and really underpins the culture and purpose of what we are about.
"Rare diseases is a space where we can bring real hope to our patients and the like-minded individuals working here are unified in a common purpose.
As a global biopharmaceutical company dedicated to developing and commercialising innovative therapies for patients with serious and life-threatening genetic diseases, BioMarin is focused on developing first-in-class and best-in-class therapeutics with the potential to improve clinical outcomes for patients diagnosed with rare genetic diseases.
The company currently has a number of approved products that are the only therapies available on the market today for the diseases they treat, as well as multiple clinical and pre-clinical product candidates.
Since opening its doors in Shanbally in 2011, the company has grown to just over 350 employees in Cork, with an additional 50 people based in Dublin and more than 2,500 employees globally.
As a global leader in the manufacturing of treatments for rare diseases, the company has quickly gone from strength to strength in Ireland.
The Shanbally operation is ideally positioned to accommodate this latest €38 million expansion due to the existing skill base and the proven track record of its success in Cork over the past seven years.
“We have been particularly successful at BioMarin in Ireland in always being able to hire the kind of people that we want,” Mike explains of the availability of graduates and skilled talent coming to the Shanbally facility.
“We have a great relationship with third level institutions such as UCC and CIT. We started our own graduate programme three years ago and are actually on to our third cohort of graduates at the moment.
“There is a great buzz around people wanting to come here, and we are extremely happy with the graduates that we are getting, together with all of those coming in on internships as well as those who’ve gone back to college and subsequently come back to us.”
Graduates rotate across functions which include manufacturing, science and technology, quality assurance, engineering and maintenance.
“By rotating the graduates through different functions, they get a good feel for the business.
"The advantage for graduates coming to BioMarin is that we will expose them to everything we do at the site.
"Science and engineering are the two key areas we are focused on and plan to continue into the future,” he adds.
“Graduates get every opportunity to work in a fast-paced company with a real focus on patients and science.”
Mike points out that BioMarin’s strong scientific culture allows for the development of technical skills through providing a career ladder up to fellow scientist level (equivalent to a company vice president).
"We have hosted some Master’s graduates from University College Cork, University of Limerick, Institute of Technology Sligo and Cork Institute of Technology, all of whom have come to work with us on specialised technology projects in sciences and technology, manufacturing and engineering.
"Many of those graduates have continued with us as full-time employees.”
BioMarin was founded in 1997 and has more than 2, 500 employees worldwide.
Headquartered in San Rafael, California, USA, with manufacturing facilities in Novato, California, and Shanbally, the company has regional offices in Dublin, London, Hong Kong and Sao Paulo, and has recorded a 1,200% increase in revenue from 2006 to 2016.
Meanwhile, last year, BioMarin constructed the world’s largest gene therapy manufacturing facility of its kind in Novato, which was named 2018 Facility of the Year Category Winner for Project Execution by the prestigious International Society for Pharmaceutical Engineering.
“The build-out of our gene therapy manufacturing facility was a logistical challenge that required leveraging our experience gained during licensure of our Galli and Shanbally biological facilities,” said Robert Baffi, Executive Vice President of Technical Operations at BioMarin.
“This plant provides us with scheduling flexibility allowing for rapid product development and is capable of providing sufficient capacity to meet clinical and projected commercial requirements.
"In addition, it creates the opportunity for our engineers and scientists to establish a valuable knowledge base required for manufacturing complex gene therapy products.
"This project demonstrated how the industry’s best people, equipped with the right technology and energized by the right motivation, can make a seemingly impossible project possible.”
Forbes Magazine last month ranked BioMarin amongst the ‘World’s Best Employers,’ within the top 300 out of a total of 2,000 companies and fifth among the nine biotech companies named.
This marks the second time this year that BioMarin has been acknowledged as a top place to work by Forbes — having also been named on the magazine’s list of ‘Best Mid-Sized Employers,’ with a ranking of 51 among 500 companies and third among biotech companies also included.
BioMarin also appeared on the magazine’s ‘Most Innovative Companies’ list four years in a row, where it was ranked in the top 15 each year.
The company has a strong track record of developing and commercialising new treatments significantly faster than the industry average and the company reinvests nearly 50% of its annual profits back into Research and Development.
For Mike O’Donnell, the last seven years at the Shanbally facility have been challenging and exciting — and there’s the prospect of even more exhilarating times ahead for BioMarin.
“While our industry didn’t suffer as much as other sectors in the economic downturn, there is no doubting the really significant bounce-back that is everywhere to be seen in Cork and the general region in recent times,” he observes.
“Many of the companies around us here at Ringaskiddy are investing in their facilities at present, and Cork is really strong with great talent in this area.
"It was really gratifying to visit Science Week at UCC recently and see so many young people interested in science and engineering.
“Cork has so much to offer as a region — both in terms of employment and quality of life now, a place where graduates can develop and grow their careers without leaving the county.
"It truly is a place full of opportunities.”