WIB Profile: Sponsors And CMOs Require Production Flexibility

By Ed Miseta, Chief Editor, Clinical Leader

Drug manufacturers today, be they pharma companies, biotechs, or CMOs, are increasingly demanding flexibility in their manufacturing processes. To meet their manufacturing needs, these companies are looking for solutions that will allow them to produce in smaller batch sizes, using disposable solutions, in facilities that can easily be converted to produce different products. So who better to provide those solutions than someone who has spent her career dealing with change.

When I selected Mary Lavin to be the focus of this Women in Bio profile article, I thought she was remarkable for a couple of reasons. She has managed to rise to an executive-level position in a traditional and conservative European-based company, in an industry where upper management is male-dominated, joining the company with just an associate degree in accounting, and did it while juggling her career, school, and family life. This experience now helps her to understand the pressures drug manufacturers face.    

Her rise to the position of president of the five Sartorius companies based in North America was not the typical path of many life science executives. She joined the company in 1988 as a staff accountant and was able to advance through the organization via promotions to chief accountant, assistant controller, controller, VP of finance, head of operations, and finally president. Along the way she earned a bachelor’s degree in accounting, a master’s degree in business, a senior professional certificate in human resources, and took numerous leadership development courses. “I always knew I wanted to do more than accounting,” she says. “I wanted to be a part of the operations group, and I always enjoyed working in sales and being of part of the strategy development team. Although my job was creating profit and loss statements, I always wanted to understand what all of the numbers meant.”

Today she manages all of the Sartorius entities in North America, overseeing two sales and marketing companies in the U.S. as well as Sartorius Canada and a production plant in Puerto Rico. She also has functional responsibility for human resources in North America and Latin America. Lavin is also a member of the greater New York City chapter of Women in Bio.

“I make sure we are executing the strategy that has been established by the corporate headquarters in Germany,” notes Lavin. “I focus on the business entities, the industries we operate in, having the right resources and products in the right places, and anything else necessary for us to be successful. Although our overriding strategy comes from headquarters, I steer that strategy in North America and make sure operations is properly executing it.”

In the U.S. Sartorius has two distinct divisions: a bioprocess division and a laboratory products & services division. The laboratory products are mostly instruments or small consumable products used in laboratories. On the bioprocess side the company provides a full range of biomanufacturing products reaching both upstream and downstream.

Ed Miseta: What do you enjoy the most about your job?

Mary Lavin: We are a smaller entity compared to many of our competitors, but that enables us to be more nimble. It also enables us to have a strong connection to our customer base, so as to understand their problems and help solve them. All of our customers are in pharma, CMO, and biotech companies, and it’s exciting to sell products that will become part of a solution that might eventually help patients overcome their diseases.

Miseta: What is one of the major trends you see occurring in the biotech industry?

Lavin: Without question, we continue to see the industry moving away from large batch production in stainless vessels to smaller batches in single-use systems. This is being done to allow companies to be more flexible when manufacturing biologics. We are seeing that with the pharma and bio companies, but also on the CMO side. More companies are going with integrated solutions, or suites, that allow them to do several of their production steps with more flexible equipment. An integrated suite might include a filtration product, a single-use product, a fermenter, and other pieces of equipment that perform a bioprocess step.

Instead of building a large facility, companies can now build a smaller factory, bring in the equipment they need, and produce their product. In a few years if they need to change that factory over to a different product line, they can easily move out the old equipment and bring in new equipment. If you had a large factory with all of the equipment built into it, you would not have that flexibility.

Miseta: What do you believe is driving that trend?

Lavin: It really has to do with being as efficient as possible. I think that when you hear the term efficiency, you just generally tend to think about money. But there is more to it than that. With a 20,000 liter tank, you can only imagine the amount of time and effort it would take to clean it, as well as the lines that are connected to it. The FDA has become more heavily focused on the supply chain, which means every step has to be clean and traceable. With a large tank, the downtime could be five days or more depending on the media…perhaps weeks. And then you have to make sure your people are using the right solvents and performing the cleaning correctly. Cost may be a factor, but all of this really revolves around companies being as efficient as possible. By having more flexibility with these types of processes, manufacturers can easily split them up and perform them in different places.

The smaller batches also mean manufacturers can carry smaller inventories, which can be increased or decreased at will. Obviously this allows them to better manage their risk, since carrying too little or too much inventory can cause problems. Converting a factory from one biologic to another can be so costly, that some companies opt to not do it at all and just move to another building.

Miseta: Companies are also facing industry pressures…   

Lavin: Absolutely. There are market pressures as well as economic pressures. Pharma and biotech companies must become more productive to overcome them. This requires companies to be economically aware of the cost of producing their products. There are pressures companies face now that perhaps did not exist in the past. Eventually those pressures will affect pricing and I think companies need to be aware of that and take action to be prepared for it.

But remember too that if a contamination issue arises in a large batch, or if it carries over from one batch to another, this can also potentially result in a shortage of a drug, which would then affect patients. The loss could cost the company millions, whereas smaller batches will reduce that risk.

Miseta: Since you oversee the human resources function in North America, do you find it difficult to find the talent that you need?

Lavin: Finding and hiring the right people, and properly developing them, is always a challenge. We hire individuals from our competitors but also from pharma and biotech companies. Being in a supplier company versus a pharma company is like being in an entirely different world, so we need to make sure they are all properly trained. As you know we are about to open a new Application Center at our North American headquarters in Bohemia NY, so staffing is very much a concern for us. Regardless of where these employees are from, the challenge for us is to always find the best and brightest in the industry and to keep them engaged.        

Miseta: Do you see women making advances into higher positions in the life science industry?

Lavin: I think so and I have always felt that networking and relationship building with those above you is an incredibly important part of that. Balancing a professional life and a personal/family life can be very difficult for women. I feel I have been successful in my career by demonstrating my competence at every level. If there was a position I wanted, I got to it through hard work, being present and engaged, and communicating across the company. Even doing all that, it was difficult to break through to some of the higher-level positions. Through the work I was doing I was able to connect with many of our executives, and I think that helped me a lot. At first I may have been looked at as a woman, but eventually my performance made me a valued contributor, and at that point my gender didn’t seem to matter anymore. That made it easier for them to consider me for the next level.

Miseta: Are we doing enough to get more young women involved in the sciences?

Lavin: I think we have made great strides but can still do much more. Biotech is an interesting industry to be in, and it is one that is dynamic and changing. I feel women are an untapped resource in this industry, and we need more of them involved for it to be successful.

This is an area where groups like Women in Bio can make a difference. By going to the high schools and colleges and talking to young women about the opportunities that exist in this industry, we can develop that interest in them. Many may not be aware of the opportunities that exist here. We need for them to know this is an exciting industry with a bright future and there are a lot of jobs available to them here.