written on 18.07.2019

Rayne Waller – VP Manufacturing, Amgen Manufacturing, Puerto Rico

Rayne Waller, VP Manufacturing for Amgen Manufacturing Limited in Puerto Rico, is leading the operations at the company’s largest manufacturing facility in Juncos, which manufactures more than 90 percent of Amgen’s products. He highlights the importance and competitive advantages of Puerto Rico for Amgen, while also explaining why the company is the employer of choice on the island.


The competitive spirit that makes operating on the island attractive is still present

You were appointed head of manufacturing for Amgen in Puerto Rico in April 2019, having worked here at Juncos between 2002 and 2007. How was the biopharmaceutical industry on the island changed in the last fifteen years?

Overall, I would say that not too much have changed with respect to the industry on the island. We still see most of the players present on the island today as fifteen years ago and the competitive spirit that makes operating on the island attractive is still present. What strikes me most about Puerto Rico is that the industry and the people here are very resilient. This spirit existed back when I was here between 2002 and 2007 and is even more present today. Moreover, there still exists a huge collaboration between players in the industry to maintain the status of Puerto Rico as one of the manufacturing hubs in biomanufacturing that can compete favourably with the likes of Ireland and Singapore.


What would you highlight as the competitive advantage of Puerto Rico compared to other manufacturing hubs around the world, you have worked at?

While the competition for attracting new business is always increasing, Puerto Rico remains a preeminent player due to its focus on education and technology. There is a strong knowledge base in pharmaceutical operations here in Puerto Rico that is continuously augmented by the capable science and engineering talent coming out of the local universities. It is this capability, along with the local industry desire to continue to innovate and compete, that makes Puerto Rico an attractive place to do business.


Before coming here, you were heading the EU region manufacturing and supply chains operations. How has your past experience prepared you to take on this new responsibility?

At Amgen, one of the goals for developing leaders is to expose them to cross-functional leadership opportunities where they can also be exposed to diverse cultures. I have been very fortunate during my 27 years at Amgen to have had the opportunity to work in varied roles both in Supply Chain and Manufacturing in multiple parts of the world that have culminated in taking on our largest manufacturing site in Puerto Rico.

Throughout my career, I had the opportunity to lead each distinct manufacturing and supply chain node across the operation to give me the capability and experience to now lead the end to end operation from Drug Substance through Drug Product in my current role. I served in Corporate, Regional and Site Supply Chain roles during my time in that organization, was a plant manager for Drug Substance during my first stint in Puerto Rico and was most recently the site head for European Drug Product manufacturing and distribution. All of this has helped equip me to manage the facility here in Juncos which has two Drug Substance facilities, Drug Product formulation and filling Inspection and Packaging, Small Molecule tableting and world-class Quality Control labs and Process Development facilities. I am truly blessed to have this leadership opportunity.


While Amgen has many manufacturing plants worldwide, almost all of the company’s main products are produced here in Juncos. How do you rate Puerto Rico’s importance for the company?

Our site located in Juncos is the flagship facility for Amgen and with over $4 Billion in investment, it serves as the most important site in the network. Amgen is ever-expanding as our pipeline continues to grow and it is my intention to ensure that the Juncos site also grows in its capabilities and capacity to ensure we can meet Amgen objectives and serve our patients around the globe.


Given the importance of Juncos, how do you ensure that drug supply is not interrupted?

It starts with ensuring that there is a reliable and efficient infrastructure, which requires constant capital investment to keep the facilities robust. We do not only have hurricane contingency plans but also protection against seismic activity. This includes business continuity and risk mitigation plans. Another crucial element is the continuous investment into staff and people, which we need to maintain as our core to ensure we are able to really meet the need of all patients no matter what happens. After Hurricane Maria, we had 90 percent of our staff showing up for work the next day, which really shows the loyalty and dedication of our staff to Amgen.


What were your initial objectives upon taking this position?

My first priority is to maintain our track record at this site. We cannot go backwards in terms of reliability in order to continue to be able to serve every patient who needs our medicines every time they need it with no exception.  When I was here 15 years ago, we had only been producing to serve the US market and parts of Europe, while today Amgen is serving patients in over 100 countries around the world. Managing that complexity in order to ensure supply is always at the forefront but we also must continuously focus on efficiency and innovation in order to increase our capability to bring new products to our facilities.


Amgen is known as an innovator in manufacturing, as shown by recent plants build in Singapore and Rhode Island, which include next-generation biomanufacturing. How does Amgen ensure that older plants like Juncos are up to date with the latest technology?

While there are many new manufacturing technologies that result in increased yield and efficiency, it is not always necessary to build a new facility to implement these technologies. Our facilities can be retrofitted with these technologies to provide the same increase in yield and output.

What is most important to implement these new technologies is a strong Process Development team. We are very fortunate at our site here in Juncos to have a world-class process development team and lab that allows us to continuously advance our process capabilities to improve quality and increase throughput.


What are some of the key skills needed for global executives working in the biotechnology manufacturing field?

The external landscape is evolving at a rapid speed. The explosion in digital technology and the ability to adapt those technologies to our industry is the single most important trend that will be impacting us in the next 5 to 10 years. The key skills are related to keeping up with trends and technologies that are shaping the manufacturing and operational landscapes, in the present and the future. At the same time, we need to continue serving patients using our rooted science knowledge to transform innovative ideas and discoveries into medicines for the patients that are dealing with serious illnesses.


With 11 of the Top 20 pharma companies manufacturing on the island, there must be strong competition for talent on the island. What makes Amgen the company of choice?

I am very confident in our ability to compete for top talent. We are a premier biotechnology company with exciting job opportunities across the whole value chain from the production of the drug substance to packaging and distribution. While we have a very competitive compensation and benefits package, what brings people to Amgen is that it is an exciting place to work where opportunities to be challenged and grow to exist every day. The values we live by every day help us both attract and retain talent.

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