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Jim Donovan, Vice President at Pfizer CentreOne

Pfizer CentreOne: Making the Complex Simple, and the Critical Reliable

A pill carries a silent promise—of healing, relief, and sometimes a second chance. Behind that promise is a complex journey of manufacturing that few witness but everyone depends on. It requires technical precision, navigating ever-changing regulations, and a commitment to innovation, all balanced with speed and reliability. Pfizer CentreOne embraces this challenge, drawing on Pfizer’s global expertise and resources to deliver consistent, high-quality oral solid dosage solutions. Their approach is rooted in transparency, resilience, and a deep sense of responsibility to patients and partners alike.

Leading this effort is Jim Donovan, Vice President at Pfizer CentreOne, whose leadership is defined by clarity, trust, and accountability. Together, they ensure that every therapy they touch is produced with care and excellence, helping partners bring meaningful medicines to the people who need them most.

Let’s delve into the interview details below!

As Vice President at Pfizer CentreOne, how would you describe your overarching leadership philosophy, and how does it align with Pfizer’s mission?

My leadership philosophy is built on leading by example, transparency, accountability and servant leadership. I believe in setting a clear direction, then trusting our teams to deliver, knowing they have the tools and support to do their jobs well. That confidence only comes from leading with clarity and trust, not control.

I have also learned to be calm and consistent in my decision-making because people will forget an issue that arose, but they will never forget how you acted during the issue. This is important because the way one acts is noticed by all levels of an organization, and with the right culture, a leader’s positive traits are mimicked by those he/she serves. This is why one of my favorite quotes is, life is managed, not cured, because issues will always come up across both our personal and professional lives, but we must be mindful of how we personally respond to those issues and demonstrate the right leadership behaviors for our teams during challenging times.

At Pfizer CentreOne, adopting this mindset is vital. We work at the intersection of complexity and precision, especially in areas like oral solid dose (OSD) manufacturing, where speed, scale, and technical accuracy must align. It’s my role to create the right conditions for success across every project to ensure we meet customer expectations.

We’re guided by Pfizer’s purpose: breakthroughs that change patients’ lives. That purpose drives us to operate with focus and integrity, because leadership isn’t about titles or strategies; it’s about helping people do meaningful work, knowing that every decision we make has a real-world impact on patient lives.

What strategic priorities guide your leadership within Pfizer CentreOne? How have they evolved over recent years?

My priorities are anchored in how we operate as an integrated CDMO with the Pfizer enterprise with the systems, governance, and cross-functional coordination that drive reliable, repeatable delivery of our customers products. Strategic plans matter, but they only work when the mechanisms beneath them are robust. I focus on making sure the organization can perform under pressure, not just in theory, but in practice.

Those priorities have sharpened in response to a more volatile external environment. We’ve seen supply chains tested, regulatory expectations rise, and customers demand greater transparency. That’s led us to invest more in forward planning with new planning systems and processes, greater internal alignment, and real-time visibility internally and externally with stakeholders. For dynamic long term strategic planning that aligns with our business and the customers. Ultimately, it’s about resilience, building the capability to adapt early and maintain control to continue delivering when the stakes are high.

How do you ensure organizational agility and innovation in such a complex and highly regulated sector?

Agility starts with structure. In a complex environment, the ability to move quickly depends on having well-defined processes and the confidence to act within them. That means clarity on roles, consistency in execution, and discipline to empower colleagues to make timely decisions in the short term and long term. I work to ensure my teams have the knowledge they need to make decisions early rather than urgently.

At Pfizer CentreOne we apply the same mindset to innovation. It’s not just about chasing trends; it’s about improving how we work. Based on lessons learned and evaluating the latest technologies to perform the work more efficiently, like with AI and new planning systems. And I don’t believe AI is a trend either; it is something we are applying in ways that continue to evolve in how we better serve our customers.

This means refining tech transfer models, embedding data-led planning, and enhancing how we manage quality across sites. We focus on impactful modifications that deliver measurable results without adding additional complexity.

In OSD manufacturing, for instance, we’ve adopted technologies like advanced process analytical tools that enhance both adaptability and control. That balance is critical because in this sector, innovation can truly deliver if it scales reliably and maintains, if not improves, our compliance with regulatory operations.

Pfizer CentreOne operates as a CMO embedded within one of the world’s leading biopharmaceutical companies. How does this unique positioning enhance your value to partners and clients?

Being powered by Pfizer, Pfizer CentreOne has access to an infrastructure few contract manufacturing organizations (CMOs) can match. That includes a global manufacturing footprint, world class technical & regulatory expertise, and quality systems proven at scale and an industry- leading standardized production system implemented across our manufacturing network. When customers work with Pfizer CentreOne, they’re tapping into the same capabilities that deliver Pfizer’s own legacy building commercial portfolio.

Our position also means we have a deep, first-hand understanding of what’s at stake when it comes to managing complex, high-value therapeutic supply. That’s why we lead with reliability, maintain robust governance, and work with a clear focus on technical execution. For customers, that translates into a smoother path to market and the peace of mind that comes from being supported by one of the most experienced teams in the industry.

What are the key differentiators that make Pfizer CentreOne a preferred partner for contract manufacturing?

One of the core areas Pfizer CentreOne stands out in is the strength and depth of the Pfizer network. Powered by Pfizer, we can offer a level of operational maturity that’s difficult to replicate, and it gives our customers real confidence in our ability to deliver.

Linked to this, a key aspect that helps set us apart is our strong track record. From right-first-time execution to robust tech transfer, we focus on the details that matter most in commercial manufacturing. That includes maintaining audit-ready operations, investing in supply chain resilience and delivering high on-time-in-full performance. Combined with a collaborative, transparent way of working, these capabilities help ensure consistency, quality and long-term value across every engagement.

How does Pfizer CentreOne balance flexibility with the rigor of Pfizer’s global standards and quality systems?

Having the right mindset is key to staying flexible. We don’t see flexibility and rigor as opposites, they’re both essential to delivering value for our customers and helping to ensure therapies reach patients. Our role is to apply Pfizer’s global quality standards with the precision they require, while finding smart, responsive ways to meet each customer’s unique needs.

Ultimately, the goal is to help deliver certainty. Drug developers come to Pfizer CentreOne for quality they can trust, but they stay because we’re able to navigate complexity without creating bureaucracy.

How is Pfizer CentreOne leveraging innovation to meet the growing demands of complex compounds and specialized therapies?

We focus on innovation that strengthens delivery, which means enhancing precision, simplifying complexity and building reliability into every stage of the manufacturing process. It’s less about disruption and more about disciplined improvement to make processes smarter, faster and more resilient without ever compromising quality.

To meet the demands of today’s therapies, particularly complex OSDs, we’ve invested in technologies that improve control and predictability. From advanced analytics and digital quality systems to refined scale-up models, these tools help reduce variability and accelerate decision-making. For our customers, that means fewer delays, smoother transfers and greater confidence that their products are being handled with the care they require.

From your perspective, what trends are shaping the future of the CMO landscape, and how is Pfizer CentreOne positioning itself for what’s next?

The CMO landscape is becoming more selective and more complex. Customers are looking for fewer but deeper manufacturing relationships, prioritising quality, supply assurance and technical credibility over transactional scale. Concurrently, regulatory expectations are rising, and the demand for agility across global networks is only increasing.

At Pfizer CentreOne, we’re responding by staying focused on what we do best. That means scaling specialized manufacturing capabilities, strengthening quality oversight and continuing to invest in operational resilience. We’re also being intentional about who we work with, aligning with customers who value transparency, governance and long-term reliability.

As a globally integrated CMO, how does Pfizer CentreOne ensure consistency, quality and regulatory compliance across its worldwide manufacturing network?

Our strength lies in operating within Pfizer’s global quality system, a platform that’s been built, tested and proven at commercial scale. It ensures we uphold the same high standards across every site, regardless of geography, while still allowing for operational flexibility where it’s needed.

Our regulatory capabilities are also built on Pfizer’s global infrastructure. We draw on dedicated regulatory affairs teams with experience navigating complex requirements in more than 150 markets. That includes deep knowledge of agency expectations, proven compliance systems and access to regulatory intelligence that helps anticipate change before it happens. For our customers, that means confidence in the process and the reassurance that quality and compliance are never left to chance.

Sustainability is increasingly important in pharma. How is Pfizer CentreOne contributing to Pfizer’s broader environmental and ESG goals?

At Pfizer CentreOne, we’re fully aligned with Pfizer’s commitment to achieving the Net-Zero Standard by 2040. That means reducing our environmental footprint across the full manufacturing lifecycle, from energy use and emissions to water conservation and waste management.

We contribute through practical, measurable actions. Our teams are engaged in initiatives like renewable energy adoption, green chemistry and packaging reduction, supported by Pfizer’s global environmental management systems.

At key sites, including our Puurs, Belgium, facility, we’ve seen real impact, with significant reductions in greenhouse gas emissions. But it’s not just about performance at the site level. We also work closely with suppliers and customers to improve sustainability across the broader value chain.

For us, ESG isn’t a box to tick, it’s a long-term commitment to responsible manufacturing, built into the way we think, plan and deliver.

Finally, what message would you like to share with partners, clients, and industry stakeholders about the journey ahead with Pfizer CentreOne?

Pfizer CentreOne is evolving with purpose. Like our new tagline says, we are “A CMO for therapies that define legacies.” We are actively seeking new partners and are ready to help support our new and current customers through a long-lasting, multi-product, trusted partnership. With the skills, expertise and legacy defining know how from Pfizer, we are ready to help others build and secure their legacy across various modalities and needs.

Powered by one of the world’s most trusted pharmaceutical companies, we bring the strength of Pfizer’s global network together with the focus, discipline and technical expertise our customers rely on. The road ahead will demand more from every manufacturer: more transparency, more resilience and more precision in execution. We’re ready for that. Our commitment is to deliver consistently, manage complexity without adding to it, and continue building confidence through performance. We are ready to help you define your legacy.

I am always open to conversation too; feel free to connect on LinkedIn.