“The key word is curiosity. That curiosity helps you to question and improve not only yourself, but also your processes, your systems, and how you interact with different stakeholders.”
Jeroen Janssens, External Manufacturing Technical Operations Lead at MSD, provides insights through a technical lens on how one of the world’s largest pharmaceutical companies approaches biologics manufacturing partnerships. With over 15 years of experience spanning validation engineering to director-level leadership, he oversees manufacturing of 11 biologics whilst pioneering AI-powered solutions for complex manufacturing challenges.
In the latest PharmaSource podcast episode, Jeroen explains how curiosity-driven leadership, strategic CDMO partnerships, and emerging technologies are reshaping external manufacturing excellence at MSD.
Building Technical Excellence Through Curiosity-Driven Leadership
Jeroen’s approach to leading technical operations stems from a scientific mindset that has guided his entire career progression. His team provides technical oversight for 11 different biologics across various stages, from transfer of late stage clinical manufacturing through commercial production.
“I was continuously asking ‘how’ and ‘why’ throughout my childhood. That curiosity drove me to become an engineer, and followed me through my complete career path up to how I lead today,” Jeroen explains.
This curiosity-focused leadership translates into practical team development initiatives. The team operates monthly “ExM Tech Talks” featuring internal and external speakers discussing topics from ADC manufacturing landscapes to complex process investigations. They have also implemented “Friday afternoon learning days” with limited meetings, providing dedicated time for professional development.
“We live by the motto to experiment continuously. It’s fine to fail, but let’s try something new, see if it works, adapt and move forward. That’s how we continuously improve and develop.”
Mastering Complex Biologics Manufacturing Partnerships
The technical complexity of biologics manufacturing requires specialised expertise and robust partnership management. Jeroen describes the intricate 50-day process that transforms a single millilitre vial of mammalian cells into commercial-scale protein production.
“You start with one mL of cells and grow them up through flasks and bioreactors – sometimes up to 15,000-litre bioreactors. You can imagine you have a 15,000-litre bioreactor filled with cells, but also with dead cells, living cells, host cell proteins, and all kinds of media components.”
The complexity inherent in biologics manufacturing demands specific skill sets from technical operations teams. Beyond deep technical expertise gained through years of hands-on manufacturing experience, team members must excel under pressure whilst building relationships across different cultures and continents.
“A batch can be worth a couple of millions, so there’s quite some pressure. Besides technical excellence, they need to quickly assess different technical solutions under pressure and drive decisions with involvement of the right other functions.”
Strategic Focus Factory Model Enables Partnership Success
MSD employs a “focus factory” model for external manufacturing governance, creating virtual plants with dedicated teams responsible for specific external partners. Each focus factory operates with three core pillars: quality, technology, and operations, supplemented by CMC, finance, and procurement functions.
“The focus factory is accountable for all interactions and deliverables of that external partner. We have daily interactions with CDMOs, mostly virtual, but we try to have face-to-face meetings for tech transfers and complex investigations.”
The company is shifting towards working with fewer strategic partners rather than differentiating between clinical and commercial suppliers. This approach enables seamless transitions from pipeline development to commercial manufacturing whilst leveraging established governance structures and relationships.
“We try to work with strategic partners where we have the infrastructure set up from a governance perspective. We know how to work together, and that helps accelerate both clinical and commercial products.”
AI-Powered Solutions Transform Manufacturing Operations
Jeroen’s team is pioneering artificial intelligence applications that address real manufacturing challenges, moving beyond industry hype to practical implementation. Two key areas demonstrate particular promise: change control automation and investigation support.
“We’re building an AI agent to support change controls. For every change our external partner makes to the process, we need to assess that change to ensure there’s no impact on product quality, safety, or validation.”
The AI solution automates administrative tasks, allowing teams to focus on core technical assessment rather than manual data entry. Currently, teams manually process PDF reports from suppliers and transcribe information into internal systems – work that AI agents can perform automatically.
A second AI application supports complex manufacturing investigations by analysing vast datasets from multiple sites alongside historical documentation.
“The AI agent takes all manufacturing data, plus data from sister sites and development work, and analyses it alongside process documentation and historical investigations. It provides a list of potential hypotheses which the team can further work on and confirm if that’s causing the issue we’re seeing.”
Digital Twins and Real-Time Data Access Shape Future Manufacturing
Looking ahead three to five years, Jeroen identifies digital ecosystem integration and digital twin technology as transformative trends for external manufacturing. Current data transfer delays of one to two weeks could evolve towards real-time access, enabling proactive process analysis and trend identification.
“Digital twins provide dynamic digital representation of your actual process and equipment. Having digital twins of bioreactor steps or purification processes helps optimise output because you’re working with biological cells with lots of variability.”
The technology promises to enhance manufacturing process optimisation by automatically adjusting downstream parameters based on real-time bioreactor data, reducing variability in complex biological systems.
“Having a digital system which gets input from your bioreactor directly – all the data understanding – will mean for downstream steps, you might need to optimise certain parameters. That digital twin will directly provide that data back and optimise your downstream process.”
