Contract development and manufacturing organisations (CDMOs) play a pivotal role in bringing innovative therapies to market. Outsourcing manufacturing operations to CDMOs enables a flexible access to manufacturing capacities and expertise within short timelines and without the need for extensive capital expenditure (CAPEX) investments.
Successfully managing CDMO projects necessitates a balance of strategic planning, skilled personnel, advanced tools, and robust internal and external networks. Furthermore, a high awareness of the customer´s needs is essential to ensure that the services meet the customer´s expectations. To fulfil these requirements and to benefit from a holistic steering of the project portfolio, CDMOs usually coordinate the project activities by dedicated project management offices.
Richter BioLogics (RB), a microbial CDMO, defined a roadmap to assure the strategic fit of project management to the company´s long-term strategy, in line with the above discussed aspects. The roadmap was established considering the anticipated growth of the project portfolio and the business volume. This article discusses four core elements of the roadmap.
- Customer focus
- Project management (PM) professionals
- Tools and digitalisation
- Network and interfaces.
Customer focus
Customer focus is a very important cornerstone of effective CDMO project management. Understanding and anticipating the needs and expectations of clients is crucial. CDMOs should be flexible in tailoring services to meet these expectations, for example by customising project timelines and deliverables or by providing solutions that accommodate changes in project scope. Keeping the client’s goals in mind and working collaboratively to achieve them enhances customer satisfaction and loyalty. For this, a key success factor is maintaining open lines of communication and ensuring transparency throughout the project life cycle. A direct contact, regular updates, progress reports and timely responses are key factors in keeping the client engaged and informed. Ultimately, good communication builds trust and fosters long-term relationships.
The regular collection of customer feedback facilitates an open exchange on how the performed services meet the customer´s expectations. Such feedback should also focus on PM-relevant elements such as communication or timeline adherence to regularly check the fit of PM with the market demand. RB established a formal customer survey, which provides a platform for the collection and interpretation of customer feedback. The survey is performed by major project milestones or at least every two years with each customer. The survey methodology is based on the net promoter score (NPS) approach and the responses are evaluated both on an individual level for each project as well as holistically for the entire CDMO project portfolio.
Beyond identifying strengths and potential gaps, the survey also feeds relevant information into the strategic considerations of the company including the definition of dedicated improvement actions. By this, RB assures the client feedback is channelled into the continuous improvement of the company’s services.
PM professionals
The successful steering of CDMO projects heavily relies on the expertise and capabilities of the project managers. Having a complete and holistic overview on the project activities and potential risks, experienced PMs bring invaluable insights into the steering of the project, which can help in anticipating potential challenges and devising effective mitigation strategies.
On the one hand, this relies on an experience in chemistry, manufacturing and control (CMC) matters including a technical understanding of the performed operations as well as on a solid knowledge of the respective good manufacturing practice (GMP) requirements.
On the other hand, strategic thinking is a critical attribute for project managers. It not only involves managing the day-to-day operations of the project but also aligning project activities with the broader business objectives of both the CDMO and the client. This holistic approach ensures that the project delivers value on multiple levels, from cost efficiency to timeline adherence as well as regulatory compliance.
In addition to experience and strategic thinking, the skills of the PM professional are paramount. Effective communication, problem-solving and negotiation skills are essential for navigating the complexities of biopharmaceutical projects along the expectations of the customers and in line with the CDMO´s procedures and capacities. Project managers must be adept at coordinating cross-functional teams, managing risks and communicating at different levels of the organisation to ensure that project milestones are met within the agreed timelines and budget.
To have a solid understanding of the required PM skills, a target skill profile can be created based on which individual or general training and qualification plans can be defined. This helps for the organisation to select and qualify the right people for the PM role and it also helps PM associates to have clear objectives regarding the necessary skills.
Tools and digitalisationTools digitalisation
The application of digital tools in project management is essential to support effective planning and controlling of project execution throughout the entire project life cycle. Moreover, digital tools allow a consolidation of business processes and enable scalability.
Various integrated project management software solutions are available on the market, and a key step for the successful application is the selection of a suitable tool. For this, a good understanding of business and user requirements is mandatory. RB initiated a company-wide digitalisation project for the selection and implementation of a PM tool, which included the mapping of business processes to select a tool that can be implemented without major adjustments in existing business processes or the tool itself. This focused approach allowed a quick and successful implementation with high acceptance of the new digital tool from the start. The three major modules covered by the PM tool are depicted in Figure 1.
The integrated PM tool assures a common data source accessible to project staff, project managers and line managers, thereby providing reliable real-time project data to identify risks and make informed decisions as a basis for the successful realisation of customer projects.
The toolset of project managers goes beyond the use of a single software solution and includes also other tools for communication, task management, visualisation and reporting, as well as meeting planning and moderation. Skilled utilisation of such tools is key for effective project steering and enables efficient collaboration within the project team. Regular training of project managers in the targeted application of these tools as part of their daily work is therefore a key for a professional PMO.
Figure 1: The three major modules of the PM tool and the utilisation of the captured data for key aspects of project management
Network and interfaces
The success of a CDMO is often determined by the strength of its network and the effectiveness of its interfaces. On the one hand, strong and long-term relationships to active or potential customers are key for a maximal utilisation and proper planning of available capacities.
On the other hand, building a robust network of suppliers, subcontractors and partners ensures that all necessary resources and expertise are readily available. These external networks should be characterised by reliability, quality and flexibility to adapt to the dynamic needs of biopharmaceutical projects.
Project managers play a key role in the development of good external relationships and also need strong internal networks within the CDMO, reaching into all departments and operational levels. Therefore, project management must have a profound knowledge of interfaces and communication best practices to ensure that information flows seamlessly across the project ecosystem.
Figure 2 depicts a quantitative evaluation of PM interfaces based on the business process model at RB. The distribution of the number of connections demonstrates the diversity of a PM´s interfaces including numerous interactions with the customers as well as internal lines including subject matter experts, functional (stream) leads as well as various management functions.
PMs should have an awareness of the importance of networks and should be enabled in terms of skills, tools and resources to perform effective networking.
Figure 2: PM interfaces according to the Business Process Model of Richter BioLogics. The bars represent the number of business processes, where PMs have an interaction with the specific role
Conclusion
Executing biopharmaceutical CDMO projects with a customer focus requires a multifaceted approach. By keeping customer needs in focus, leveraging the expertise of skilled and experienced project managers, a targeted application of digital tools, and building robust networks, CDMO project managers can effectively steer the execution of complex biopharmaceutical projects. The presented holistic approach not only enhances project outcomes but also builds lasting relationships with customers, where the CDMO acts as trusted partner in the development and manufacturing of innovative therapies.
Nele Petermann received her diploma in Biotechnology from the
Technical University in Braunschweig, Germany. After having worked on the purification and characterisation of biologicals at the university of Lübeck and the Max Planck Institute for the dynamic of complex technical systems in Magdeburg, also Germany, she joined Richter BioLogics in 2010 and has been a project manager of multiple CDMO projects from preclinical to commercial stage since then.
Tobias Meder holds a master’s degree in industrial engineering from the University of Applied Science in Stralsund. He worked for five years as business process and lean expert in the automotive business. Now he is responsible for the implementation of business process management (BPM) at Richter BioLogics GmbH & Co.KG.
Denes Zalai graduated as a bioprocess engineer and achieved a PhD
degree at the Bioprocess Technology working group of the Vienna
University of Technology, Austria. He started his professional career as a bioprocess development engineer at Gedeon Richter, a Hungary-based pharmaceutical company. After gaining further expertise in drug substance manufacturing, he has been responsible for customer project management at Richter BioLogics.
