Skip to Content
Expert Insights

Project Management in Biologics Development: A Comprehensive Approach

Project management encompasses the full cycle of initiation, planning, execution, control, and closing. This pathway has been successfully implemented in biologics development and has garnered significant recognition. At Bora Biologics, located in Taiwan and San Diego, California, our Project Management Office (PMO) brings over a decade of experience navigating the strategic transition from an innovation-based biotech to a globally integrated Contract Development and Manufacturing Organization (CDMO). This journey has shaped our core belief: project management is the engine that drives delivery, trust, and growth within a client-centric business model. In today’s increasingly complex biopharmaceutical landscape, project managers are no longer just facilitators; they are valued architects, balancing scientific precision with commercial execution.

Operating at the intersection of biologics development and global outsourcing expectations, CDMO-focused project managers must lead with both agility and discipline. Our clients—ranging from top 10 global pharmaceutical companies to emerging biotech firms—entrust us with their most promising assets. They expect speed, quality, transparency, and partnership. Meeting these expectations requires more than technical expertise; it demands proactive leadership, cultural intelligence, and the ability to orchestrate cross-functional, multi-site teams under strict regulatory and timeline pressures.

Taiwan’s strategic position in the Asia-Pacific region gives us an edge in supply chain responsiveness and talent development. However, it is our CDMO mindset—anchored in service, accountability, and innovation—that truly sets us apart. Our PMO team plays a pivotal role in embedding this mindset across the organization. We are trained to think globally while acting locally, translating diverse client needs into executable development plans and ensuring seamless integration from tech transfer through Good Manufacturing Practice (GMP) manufacturing.

At our core, we operate with a client-first philosophy. Every program is unique, but the foundation remains the same: we listen closely, anticipate challenges, and solve collaboratively. As the PMO leader, I have championed a model where project managers act as empowered business leaders—owning timelines, budgets, risk mitigation, and communication. This approach builds confidence with clients and fosters long-term partnerships rooted in reliability and shared success.

The evolution from an innovation-driven biotech to a CDMO has necessitated a shift in mindset—from pushing internal pipelines to enabling external ones. It’s a shift we have embraced with purpose. Our role is not to be the hero of the molecule but the trusted guide that brings it safely, efficiently, and compliantly to its next milestone.

In a global biologics ecosystem defined by speed and complexity, the CDMO-focused project manager is more critical than ever. We don’t just manage timelines—we shape outcomes, amplify client vision, and accelerate access to life-changing therapies worldwide. Our goal is to use our experience to make success more certain.

As we embrace the future, we invite you to join us in this journey. Connect with Bora Biologics, and let’s unlock the potential of your projects together.

About the Author

Rose Chen is a seasoned CMC project manager with over 10 years of experience in the pharmaceutical industry. As the Director of Business and Program Management at Bora Biologics, she leads the Project Management Office (PMO) team in overseeing pipeline and CDMO projects for biologics and complex molecules. Rose has successfully filed Investigational New Drug (IND) applications across several regions, including with the U.S. FDA, Australia, Europe, and the National Medical Products Administration (NMPA), contributing to multiple Phase 3 global studies.

Since joining Bora Biologics in 2016, Rose has been instrumental in business management and client engagement, ensuring on-time delivery and fostering clear communication. Her strategic focus on driving revenue growth underscores her commitment to excellence in project execution, essential to Bora Biologics’ mission of advancing biopharmaceutical innovations. With an MS degree and Project Management Professional (PMP) certification, Rose combines her technical expertise with a passion for delivering impactful results in the dynamic landscape of biopharmaceutical development.

Bora Biologics

the logical choice

Join the ranks of biopharma pioneers who trust us.
Explore how we minimize risks and accelerate your success.

Partner with us

Client-Centric

100% commitment to supporting your success

We have been the client, bringing multiple biologics from IND to BLA. Your needs and goals are at the forefront of our approach. By involving you in every step of the process, we ensure transparency and alignment, reducing the likelihood of misunderstandings and ensuring the outcome meets your expectations.

Experience

14 years developing & manufacturing biologics

We have honed our ability to navigate complexities. Our track record from concept to commercialization means we can apply best practices and lessons learned, ensuring smoother project execution.

Expertise

125 seasoned scientists & regulatory professionals

Our team exudes deep knowledge and specialized skills. This expertise allows us to foresee potential challenges and implement proactive solutions, reducing the likelihood of setbacks.

Commercial-Ready

US FDA registered GMP manufacturing facility

We focus on delivering solutions that are ready for market. With clinical to commercial scale facilities consistently meeting compliance standards, we ensure your project is primed for success, minimizing the risk of costly revisions or delays.

Allied

access to global CDMO resources

Our partnership with Bora Pharmaceuticals provides additional resources and insights. This network enables us to leverage shared knowledge and expertise, further mitigating risks and accelerating the overall success of your project.