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Project management is vital to the effective delivery of biopharma services. Outsourcing partners work upfront to ensure everything goes to plan but cannot assume projects will progress as expected. There is always a risk that a project will deviate from the plan, for example when unforeseeable events delay a task. Leading CDMOs recognize that risk, track data on their progress, and act decisively to get back on course quickly if a project starts missing performance targets.
Effective project management supports timely, proactive course correction to prevent small setbacks from escalating into problems that prevent service providers from fulfilling all orders on time and in full, first time, every time.
At Piramal Pharma Solutions (PPS), a contract development and manufacturing organization (CDMO), a company culture focused on patient and customer-centricity has manifested in a deep commitment to the optimization of project management. By establishing a company-wide system for monitoring and acting on key performance indicators (KPIs) and other metrics, the CDMO and its team of experienced pharma project and program managers have adopted industry-leading practices across the organization.
Piramal's approach to project management is based on a proactive Plan, Do, Check, Act methodology that is designed to ensure a smooth interface between project execution and management. The model reflects a continuous improvement mindset, enables Piramal to course correct as needed, and ensures the client is involved with key decisions every step of the way.
Every Piramal project has its own site-based leader, the project manager, who is intimately familiar with the project. The project manager actively leads the project team, by coordinating multiple department representatives, providing feedback and direction to the team, and proactively escalating issues when needed to ensure the site meets its obligations under the agreed scope, budget, and timeline for the project.
While project managers are perfectly placed to oversee activities at a single site, they lack the vantage point needed to deliver complex programs that require the coordination of multiple facilities. In those situations, integrated program managers are needed.
Program managers keep track of the big picture, working to coordinate the teams at different sites and thereby deliver a seamless, integrated service to the client. Coordinating all the site-based teams and integrating the project-level outputs maintains consistency from site to site and ensures the goals of the overall program are met.
The model requires clear, constant communication between project managers and program managers. By working side by side with the project managers, program managers establish a holistic view of complex, multi-site programs, equipping them to serve as the single point of contact for clients and represent the overall needs of the client's program at site based planning meetings and internal business review meetings.
At Piramal Pharma Solutions, the project and program manager roles go beyond the administrative responsibilities of documenting tasks and actions, organizing meetings, and sending out the minutes. They are the true leaders of clients projects across all the sites.
To enable staff to meet that responsibility, Piramal empowers project and program managers to hold other people accountable, lead internal and external communications, find solutions to any problems that arise, and proactively escalate challenges to expedite their resolution. The idea is to give project and program managers the tools and training they need to be effective leaders and provide the best service to Piramal's customers.
The two roles have demanding responsibilities but the team is given the power and support they need to succeed. That combination of demanding but rewarding work and a supporting organization has helped Piramal to attract and retain high-quality project and program managers.
Almost 70% of Piramal's global project management team have worked in the pharma industry for more than 10 years. The team's pharma experience covers a wide spectrum of activities, including manufacturing operations, process development, R&D, finance, regulatory, IT, and account management. All of the managers have a degree-level education. Two-thirds have received a masters or a PhD. One-third have certifications from project management organizations, six sigma, or other similar courses.
The project and program managers are supported by powerful software, Smartsheet, that enables them to connect and report project information from multiple sources and customize that output for different audiences. Using the software, data can be collected from different sources to create dashboards that display the KPIs and metrics needed to monitor the performance of projects. The goal is to give every project and program manager ready access to the information they need to assess if a project is on track.
Piramal has worked to standardize every aspect of the project management methodology across all of its sites. The company has compiled its processes into the “PM Playbook,” a document that defines and standardizes its approach to project management so that the methodology is the same through the lifecycle of any project at any site.
Piramal has made the playbook, which is hosted on a dedicated intranet site, available to the entire team working on a customer's project. Extending access beyond the project and program managers equips all team members to see who is responsible for different tasks and play their part in ensuring the successful delivery of their projects.
The standardization drive is the product of the global program management office. Piramal tasked the office with standardizing the processes and tools that it uses across its entire network. The result is a globalized connection that enables centralized training of the project and program managers and allows them to share best practices and learn from each other's experiences.
Structured communication and clear escalation pathways are part of the standardized approach and key enablers for program success. Discussions involving project teams happen weekly or bi-weekly to ensure the timely identification of issues, while operational teams and steering committees meet less frequently to consider longer-term matters such as site-level oversight and strategic relationship building.
Piramal Pharma Solutions' commitment to continuous improvement has turned project management into a competitive advantage. The integrated program management function sets Piramal apart from other CDMOs. While many CDMOs offer a range of services across different sites, effective program management is needed to integrate the activities at multiple sites and ensure projects move smoothly from one stage to the next.
The standardized approach to project management and the installation of the program management function for complex projects at Piramal mitigates the risk for all projects. Each site-based activity, and every handover between sites, is overseen by a dedicated team of project and program managers that have the information and resources to find and resolve issues before they escalate. The result is a system that ensures the effective deployment of expertise and capabilities around the world and the on time, in full delivery of projects that are crucial to Piramal's customers and patients with unmet medical needs.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.
