Four Steps to Successful Project Planning and Controls

Co-authored by Adam Barlow, Sr. Vice President and Scott Reynolds, Sr. Director

Navigating the journey from drug discovery to market is complex and fraught with potential setbacks. Formulating a realistic biotech manufacturing timeline requires meticulous planning, strategic foresight, and proactive anticipation of potential obstacles.

Imagine your company aims to have a product commercially ready in two years, but the timeline overlooks real-world variables. The result? Missed deadlines, higher costs, and delayed patient access.

Critical path drivers are unpredictable. Project managers must stay vigilant, adapt to risks, and develop robust mitigation strategies to ensure smooth execution. Without flexibility and realistic expectations, a single misstep can derail the entire timeline. In drug manufacturing, a skilled team is essential for timely project completion.

Our experts recommend four key steps to guide biotech manufacturers in project planning and controls.

Step 1: Create a Spider's Web of Deliverables

Expanding manufacturing capabilities involves scaling up processes or building new facilities. In biotech construction, numerous factors like infrastructure issues and late equipment deliveries affect schedules.

Instead of a simple start-to-end timeline, project managers use an integrated program schedule resembling a spider’s web, with interrelated workstreams and critical paths. This "spider diagram" outlines tasks and their connections, allowing managers to track progress and identify shifts in critical paths.

As workstreams complete deliverables, the critical path moves to the next task. For example, after constructing the facility, power installation supports IT infrastructure, which then allows HVAC automation. Concurrently, equipment and raw materials must be selected, procured, installed, and tested. These interconnected elements impact the project’s scope, schedule, and cost. A dedicated project controls team can be the project manager's eyes and ears ensuring everything aligns for success.

Step 2: Divide and Conquer Project Management

Separating project controls from project management allows each to excel. Project controls teams gather and consolidate crucial information, while management liaises with stakeholders for key decisions.

The project controls team monitors individual tasks and workstreams, identifying patterns and trends, such consistent deadline misses. Consider this: If only 60% of deliverables are completed on time, the entire project will be delayed. Identifying and flagging delays early on saves time later.

With this approach, the team can alert the project manager to problems before they spiral, enabling re-sequencing of work or adjusting priorities to keep the project on track.

Step 3: Float on the Workstream

Managing a shifting web of tasks requires the project controls team to monitor deliverables across manufacturing, engineering, quality, and regulatory departments. They track changes in the integrated plan and collaborate with the project manager to determine the float, or schedule flexibility, for each deliverable.

While some items carry zero float and cannot be moved from their position on the timeline, others can be shifted without creating delays. By adjusting tasks with float as needed, the project remains on time despite supply chain issues or other delays. Completing tasks ahead of schedule, like drafting regulatory documents during construction, can also save time later.

Managing a project's numerous activities—from a few hundred to tens of thousands—requires a system of checks and balances, hands-on relationships, and routine communication. Regular site visits and direct conversations are more effective than emails for tracking progress and ensuring accountability.

Step 4: Form a Project Controls Workstream

In pharmaceutical and biotech manufacturing, project controls workstreams are crucial for aligning all elements with project goals. To create effective workstreams, assemble a team of experts in regulatory compliance, quality assurance, supply chain management, and financial oversight. Each workstream, led by experienced professionals who understand the nuances of their specific area, must work harmoniously to build a coordinated project framework.

Define the scope and objectives of each workstream to align with the broader project goals. Set up milestones and key performance indicators (KPIs) to measure progress and promptly address issues.

Communication and collaboration are the lifeblood of project controls workstreams. Regular meetings, status updates, and cross-functional collaboration are essential for maintaining alignment and addressing challenges. For pharmaceutical and biotech companies, an adaptable workstream can not only enhance the efficiency of their manufacturing projects but also proactively manage risks, reduce bottlenecks, and ensure timely delivery of vital medications to patients in need.

Final Thoughts

Successful project planning and controls in biotech manufacturing require a comprehensive approach. Setting realistic timelines and understanding the dynamic nature of critical path drivers are essential. Adapting to unforeseen changes, managing risks, and employing effective strategies ensure the project stays on course. Dividing the project into manageable workstreams, closely monitoring progress, and forming dedicated project controls teams are practical steps that lead to success.

By embracing these four critical steps, biotech companies can navigate the challenging path from drug discovery to manufacturing and marketing more efficiently, keeping projects on track, costs in check, and delivering benefits to patients in a timely manner.

Click here to download our recently published Precision Manufacturing eBook for more patient-focused manufacturing insights.

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