Sterling Snapshot | Adam Kujath, EVP and Site Head at Germantown

Adam joined the Germantown facility after finding a passion for Chemistry at Carroll University. Now, as EVP and Site Head, Adam’s role involves working with and supporting our customers’ projects, working on our five year site strategy and being involved in technical discussions with the chemistry team.

Can you briefly describe your background?

I received my BS in Chemistry and Biochemistry from Carroll University. I found a passion for chemistry, primarily focused on synthesis and characterisation; I knew I wanted to be involved in the research side of chemistry. Upon graduation, I had a few opportunities with larger chemical companies, but opted to join a small start-up as it immediately afforded me the chance to work in development. This business continued to grow, and through a variety of mergers and acquisitions, it is now Sterling’s Germantown site. Fortunately, by working in an organisation that was going through, and continues to go through, significant growth and change, it allowed me to get a wide breadth of experience, always rooted in my love of all things technical. I’ve held individual and leadership roles in chemistry development, project management, technical services, operations, formulation development, and combined drug substance and drug product development organisations.

The variety of experiences in these roles, as well as the many customer interactions, positioned me well for my current role as EVP and Site Head at Germantown. It affords the opportunity to wear many hats. In the course of a day, I can go from hosting customers on site, to working on the five year site strategy, to engaging in a one-on-one technical discussion and troubleshooting with the chemistry team. I get to scratch both the leadership and technical itch almost every day. Getting to be a part of the talented Executive Leadership Team here at Sterling has also given me an opportunity to collaborate extensively with other parts of the organisation and sites to continually improve and maximise the network. This benefits the business and our customers. It is clear that Sterling’s values guide behaviours throughout the organisation, and I appreciate that Sterling thrives and strives for technical excellence.

Can you discuss some of the recent enhancements to the Germantown site?

High potency is one of our site’s key differentiators. We have already invested significantly in this area and are continuing to expand our capabilities. New high pressure chromatography and upgraded isolator technology to drive containment levels below 1ng/m3 with integrated lyophilisation capabilities have been and are being installed. This will not only support our current traditional small molecule development and manufacturing capabilities, but will also enhance our integrated antibody drug conjugate (ADC) offering, providing toxin-linker development and GMP production for bioconjugation services at our Deeside site. We also expanded our development lab space and capabilities, with that team growing by over 25% during the last two years, adding key capabilities like SEM-EDX. We’ve also just completed the detailed design for a significant expansion project that will nearly double our reactor capacity, taking our top end vessel scale to over 15,000L. This will be key in continuing to support the growing commercial portfolio and customer demands.

How do customer interactions inform decision making in your role?

The technical team is our customers’ first and most critical point of interaction. At project kickoff, we are focused on understanding what it is that they need us to accomplish, and aligning on how we will do it. it may be that speed will help it work quickly and hit a clinical milestone, or to minimise cost of goods, or they may be looking for a registration enabling CMC package that will support a successful NDA submission. Making sure we have this big-picture understanding of our customers’ objectives is key to aligning our priorities and approach, starting on a collaborative foot. We seek to take the time to connect with our customers and truly understand their goals. Customer connection is vital at every level and through every milestone to build long-lasting, successful partnerships. Communication is key; not everything will go according to plan but it’s how we react to challenges that will galvanise the relationship.

What are some of your goals for the Germantown site moving forward?

Our number one goal is to always be a strong, balanced and technically sound partner for our customers. Development is the first place customers step into the relationship, making it critical to establish ourselves as the right partner from the start. We add technical value through our people and our approach.

Throughout the site, we have also been focusing on embedding a continuous improvement culture; developing the training, tools, processes, resources and support to make continuous improvement a way of life. This has enabled us to improve efficiency and on-time project delivery. Even more than that though, it creates empowerment. People can see the impact of what they do every day, and what happens when we find a better way to do it. This makes for strong collaboration and helps us utilise our people and our assets effectively. Once we finish development, it’s critical that we can take it to the plant and deliver it on time, right first time.

What are some of the things that set Sterling’s Germantown site apart?

One thing that sets us apart is our work cell model for our development teams. This has enabled us to create a tight integration within our teams, as well as a high-level of product ownership during development and all the way through commercialisation. This model has become part of our culture, and our team has really embraced it. The model is unique in the CDMO space and creates a team that has a reporting structure that supports the team to make decisions based on project priority, not functional priority. This resonates with our customers, because that’s how they think: what is the best way forward for the product?

The site has also built significant specialised development capabilities that mean we can tackle a variety of products and problems. Aside from traditional small molecule, the team has successfully developed toxin linkers, peptide conjugates, HPAPI and controlled substances, spray dried products, dry and wet milling, and continuous flow processes. This is all underpinned with tools for QSAR, in silico phys-chem prediction and reaction modeling, DoE, and solid state characterisation and development that are key in delivering a strong CMC package. Bringing the breadth and depth of technical experience, along with a collaborative ad transparent approach, is a value proposition that is more critical than having nice shiny reactors.