Introduction
As the pharmaceutical landscape evolves through innovation and digital transformation, leaders like Robert Newell are redefining what it means to build resilient, patient-centric manufacturing networks on a global scale.
With nearly 25 years of experience across leading biopharmaceutical companies, Robert has held roles spanning contract and internal manufacturing, global supply chain, quality, and operational excellence. Today, as Vice President of External Operations – Global at BioMarin, he oversees the company’s global network of contract manufacturing and development partners, ensuring the highest standards of quality, safety, and reliability across late-phase and commercial products.
We had the opportunity to speak with Robert ahead of his participation at the American Pharma Manufacturing & Outsourcing Summit, taking place November 17–18, 2025, in Boston, MA, where he will join fellow industry leaders to discuss the evolving landscape of pharmaceutical operations, global partnerships, and digital transformation.
Could you begin with a brief introduction about yourself and an overview of your responsibilities as VP, External Operations - Global at BioMarin?
I lead BioMarin’s global network of external manufacturing—what we call External Operations. I’ve spent nearly 25 years across several biopharmaceutical companies, with roles focused on contract and internal manufacturing, global supply chains, quality, and operational excellence. My focus has always been on ensuring reliable supply, regulatory compliance, and the ability to scale complex products effectively.
In my current role, I oversee late-phase and commercial products and manage strategic relationships with our CMOs and CDMOs worldwide. This means ensuring that our quality and safety standards—especially those impacting patient safety—are upheld across everything we do. My passion lies in building strong relationships and high-performing teams that drive operational efficiency, performance, and innovation. At BioMarin, this is essential to ensuring that our therapies reach the patients who need them most.
How has your leadership style evolved throughout your career in global operations?
Early in my career, I was a very technical, hands-on engineer, focused on processes and systems within manufacturing. Over time, as I gained exposure across cultures, functions, and regions, my leadership approach evolved from directive management to strategic empowerment.
Key turning points came through leading global projects across regions with different expectations, from regulatory requirements to cultural dynamics. I learned that successful leadership in a global environment is as much about listening and enabling as it is about setting direction. All of this while delivering the results for the business and the patients.
Today, I focus on empowering cross-functional teams, fostering trust, and encouraging ownership. My leadership philosophy centers on clarity, transparency, and shared accountability. Each partner, whether internal or external, understands how their work connects to our mission.
What role does cross-functional alignment play in enabling BioMarin’s mission, particularly as you expand global external operations?
Cross-functional alignment is absolutely essential—it’s what enables us to transform innovative science into life-changing therapies at BioMarin.
We operate not just vertically within functions but horizontally across teams and with our external partners. In external operations, alignment between manufacturing, quality, supply chain, regulatory, and technical teams ensures that every partnership and process meets our standards and patient commitments.
Our governance model emphasizes integrated planning and communication. We bring together the right internal and external stakeholders to rally around shared metrics and goals. Whether it’s scaling for a new product launch or addressing a manufacturing issue, that one-team mindset strengthens execution and accelerates delivery, ensuring our therapies reach patients safely and compliantly.
"This is a reflection of BioMarin’s unwavering mission to make a meaningful impact in the lives of our patients."
What are some of the key qualities you believe are essential for leading global teams in today’s pharmaceutical landscape?
Leading global teams today requires a balance of cultural intelligence, adaptability, and decisiveness. It’s about respecting regional differences while maintaining a unified standard of excellence. In an external manufacturing context, this means respecting regional differences while maintaining a unified standard of excellence.
For me, clarity, communication, empathy, and trust are foundational. Leadership requires that teams across time zones share a common understanding of priorities and expectations. Empathy and trust-building are equally critical, as our success depends on partnership—not hierarchy.
Another key element is leveraging data-informed decision-making, combined with the humility to pivot when conditions change. A leader must be both decisive and understanding, blending technical expertise with human connection.
Where do you think the biggest opportunities for transformation lie in the pharma operations space today?
Pharmaceutical operations are at a turning point — where the advent of AI, digital transformation, and real-time connectivity are redefining what’s possible.
I see major opportunities in the integration of advanced analytics and real-time manufacturing intelligence across external networks. With better data visibility, we can predict issues before they occur, optimize resources, and strengthen compliance across external partners.
The goal is better data visibility—predicting issues before they occur, optimizing resources, and strengthening compliance across partners. But
transformation isn’t just about technology—it’s about people and mindset. The most successful organizations will be those that demonstrate adaptability, transparency, and cross-industry collaboration while using digital tools to create a real competitive advantage.
Among the industry peers and topics being explored at the summit, what themes are most relevant to your current challenges or strategic priorities at BioMarin?
Several of the summit streams strongly resonate with our work at BioMarin — particularly supply chain resilience, digital quality management, and agile outsourcing models.
As BioMarin expands its global external footprint, maintaining consistency, flexibility, and transparency across partners is a top strategic focus. I’m especially interested in how digitalization and AI can streamline compliance and oversight models.
I’m also interested in how other companies are structuring their external partnerships to balance speed, cost, and innovation, while maintaining the highest standards of quality and regulatory alignment. The opportunity to exchange ideas with peers tackling similar challenges is one of the most valuable aspects of this summit.
What are you most looking forward to at the American Pharma Manufacturing & Outsourcing Summit?
I’m most looking forward to engaging with industry peers and thought leaders who share a passion for transforming pharmaceutical operations. These summits are an incredible opportunity to learn, reflect, and collaborate.
Sometimes it’s about taking a step back to assess where we are and where we want to go next. I find tremendous value in building relationships and exchanging insights with others who are equally committed to advancing our industry and, ultimately, improving how we serve patients.
Conclusion
Robert Newell’s dedication to collaboration, operational excellence, and patient-centric innovation reflects the very spirit of BioMarin’s mission—and of the American Pharma Manufacturing & Outsourcing Summit itself. His insights into digital transformation, cross-functional alignment, and leadership in complex global environments highlight how the industry is evolving to meet new challenges with purpose and agility.
As he joins the stage in Boston this November, Robert will bring a unique perspective on how empowering teams, leveraging technology, and fostering global partnerships can drive meaningful progress across the pharmaceutical landscape.
Register now: posummit.com