Victor Cruz, VP-Manufacturing Puerto Rico and Brazil for Lilly del Caribe highlights the priorities in his new position and underlines the importance of the Carolina facility for the global insulin supply. He also discusses Puerto Rico’s role related to future trends in pharmaceutical manufacturing, such as AI, robotics and continuous manufacturing.
You have been more than 18 years at Lilly, covering different positions in Puerto Rico as well as in Indianapolis and in New Jersey. Now having returned to the island, what have you identified as your main priorities?
We have very clear areas of focus across all Lilly manufacturing sites worldwide. Here in Carolina, we want to produce high quality medicine with a safety-first approach. Our second priority is to launch new products with excellence, doing it right the first time to get medicines to the patients as quick as possible. The third priority is to continuously improve our competitiveness position, which applies to Lilly de Caribe here in Puerto Rico, but also to the whole Lilly organization.
Knowing other manufacturing locations from personal experience, what would you highlight as the competitive advantage of Puerto Rico compared to other manufacturing hubs around the world?
One advantage is our capabilities here in Puerto Rico, due to over 50 years of manufacturing experience on the island, which means that good manufacturing practices are in our DNA. The level of excellence in pharmaceutical and biopharmaceutical manufacturing can also be attributed to the top-notch talent we have here, developed at our high-class local universities. These two factors combined with the tax advantages the commonwealth of Puerto Rico has for businesses, are the main competitive advantages the island has over global competition.
Can you give us an overview of Lilly’s operations here in Puerto Rico?
Lilly’s footprint in Puerto Rico consists of two manufacturing sites here in Carolina. PR5 is an active pharmaceutical ingredient (API) manufacturing site, specialized on insulin production, mainly for our product Humalog. Secondly, we have PR1, which has been established 54 years ago. In this facility, we have the capabilities to manufacture any oral dosage type of products. As an example, we have our new metastatic breast cancer treatment Verzenio produced here at PR1. Across the two sites, we are manufacturing more than ten products, so we fulfill a key mission for Lilly. We are manufacturing established legacy products, while also playing a crucial role in launching new products.
Lilly has many manufacturing plants worldwide, so how do you rate Puerto Rico’s importance for the company?
Puerto Rico has been an important hub for manufacturing for Lilly for more than five decades. PR01 has been consistently manufacturing and supplying key products since our beginnings in the 1960s and PR5 is one of the largest API manufacturing sites for Lilly globally, which has been growing its capacities to stay ahead of the growing demand of the insulin market. Diabetes is one of the main treatment areas of Lilly, in which we regularly launch new products, so we are continuously updating our strategic plan to ensure ongoing drug supply. Our aim is not to only supply the Puerto Rican and Latin American market, but to supply more than 120 different countries around the world. Carolina is one of the main suppliers for nearly all Lilly affiliates worldwide.
Given the importance of Carolina, how do you ensure that drug supply is not interrupted?
It is crucial to ensure sustainability of our operations here on the island, with continuous maintenance work and business continuity plans in place, which guarantee the necessary backups and redundancies to have the plant running uninterruptedly. These are matters that we take very seriously, and we work together with the government to also confirm that the right infrastructure is in place.
Our foundation are employees that know how to make medicine, so we need to make the required investments to ensure the next generation also has the expertise and knowledge in biopharmaceutical manufacturing.
Continuous manufacturing lines are used increasingly in the industry, with Lilly being one of the frontrunners. How is that applied within the Carolina site?
The International Society for Pharmaceutical Engineering (ISPE) announced Lilly as the overall winner of the 2017 Facility of the Year Awards for our continuous direct compression manufacturing kits, which has been established here at PR1. We are proud of our continuous manufacturing capabilities and aim to maximize these in the future. Nevertheless, each product has a different business case of determining if continuous manufacturing is the most efficient way of production. We see many opportunities especially in the dry product area, so we evaluate the potential on a case-to-case basis.
With a long-track record in pharmaceutical manufacturing, what do you see as upcoming trends shaping the industry?
Technology will become an enabler of solving problems and we already see an increasing movement towards a paperless environment, with information being recorded digitally. This enables our operators to focus on their core task of manufacturing medicine while the system gathers critical information and calculations for the batch records the operator has to do manually today. This enables our operators to focus on their core task of manufacturing medicine rather than filling sheets of paper. Systems can help to gather critical information, while the operator can focus on what is happening on the floor. This transformation is a journey and we are currently in the process of installing a system, where all the information is centralized. We aim to have the approval for batches to be happening automatically, as the system has enough checks and balances to guarantee that the batch information is accurate. For an insulin-manufacturing facility like PR5, this is essential. In other areas, technologies such as robotics will be more impactful, particularly in parental facilities with huge volumes and movements of products. For the next five years, artificial intelligence and robotics are the most significant advances, and I really think we see the value of it, as it allows our engineers and scientists to troubleshoot and anticipate problems.
I believe that through using technology, executives will be able to spend more time with people, by staying closer to the floor. While, there is a risk of not applying technology the right way and disconnect employees rather than bringing them closer together, I believe technology will be a great enabler. Executives and site heads will have more real time information of what is going on the floor, which also makes it easier to manage facilities from the distance.
With 11 of the Top 20 pharma companies manufacturing on the island, there must be strong competition for talent on the island. What makes Lilly the company of choice?
We have a very strong branding here on the island due to more than 50 years of presence and Lilly embraces core values like respect for people, which personally is a reason for me to spend the rest of my career here. Secondly, we have very exciting operations, that are evolving continuously, so there are many opportunities for professionals that are looking for challenges, in all areas of expertise.
What is your vision for Lily de Caribe when we return to Puerto Rico for our next report in 2024?
Our goals are closely aligned to our priorities: firstly, I want to ensure effectiveness here in Carolina through sustainable operations, which in turn allows us to be more competitive. If we do this right, we will remain an important site for Lilly’s network and will not only be manufacturing the products that we have today, but also continue to be considered as the launching site for new products in the future. Our aim is also to work closely with the local government to ensure we provide the right environment to allow Puerto Rico’s economy to evolve and to remain competitive.
What has been your personal motivation to take on this new position?
To me both Lilly and Puerto Rico are home and as this new position combines both, I see it as a great opportunity. My previous assignment exposed me to different ways of doing things and learn best practices in many areas of the company. Hence, part of my motivation is how I can bring in those learnings to Puerto Rico and ensure to create global leaders rather than only local leaders.
