Focus Factory 1
centers on advanced injectable and drug-device programs such as auto injector and prefilled syringe assembly for large global brands.
Modern Site Operating Models for Complex Portfolios
As injectable therapies, device-based treatments, and high-value biologics reshape the pharmaceutical landscape, expectations of commercial packaging partners have shifted just as dramatically.
Product portfolios are more complex, volumes are higher and more unpredictable, and the tolerance for supply disruption has effectively dropped to zero. In this environment, the more traditional, functionally organized packaging facility may struggle to keep pace.
In response, PCI’s headquarters in Philadelphia has deliberately redesigned how it runs. What differentiates the site today is a modern operating model that connects value‑stream ownership, deeper embedded quality, and line‑level discipline into one coherent system.
Structuring Around Value Streams, Not Departments
The foundation of the evolved model is a shift from a traditional monolithic plant to multiple focused value streams known as focus factories. Each focus factory brings together a coherent set of products and technologies, with end‑to‑end ownership and accountability for performance.
In Philadelphia, the structure is intentionally aligned to where complexity and risk are highest:
Focus Factory 2
focuses on multi step sterilized biotech processes, including syringe assembly, blistering, and sterilization for high value biologics.
Focus Factory 3
manages the site’s core portfolio of bottles, blisters, vials, labeling, and kitting, where scale and mix create a different type of operational challenge.
Each focus factory has a dedicated leadership spine that includes operations, quality, business unit, engineering, and continuous improvement leads. This creates clear accountability for safety, quality, delivery, cost, and people within each value stream, while a harmonized governance layer, including daily tiered meetings, weekly operating reviews, and monthly site reviews, ensures the site still operates as a single system rather than three disconnected silos.
For brand owners, this structure means your programs are not competing with fundamentally different technologies for attention and resources. Instead, they sit in a value stream designed around the specific technical, regulatory, and commercial realities of your portfolio.
Embedding Quality as a Co‑Owner, Not a Gatekeeper
A second pillar of the model is the way quality is integrated into day‑to‑day operations. Standard industry practice often places quality at the end of the process, responding to deviations and correcting batch record issues after they’ve occurred. Like most leading CDMOs, we have always maintained a robust, independent quality function and as part of our ongoing strategy, in Philadelphia, we’ve recognized how the industry is evolving with more complex programs entering our facility and we have evolved too. We’ve now gone a step further by embedding quality leaders directly into each value stream to support this change, so QA and operations can manage risk together in real time while preserving full independence at release.
Instead of tracking batch record right‑first‑time (RFT), deviation trends, and release performance as isolated functional metrics, the team reviews them in the context of the value stream’s overall plan. Root‑cause analysis and corrective actions are designed jointly, so solutions reshape execution and process design, not just the paperwork that sits around them. When issues arise, the cross‑functional focus factory team owns both the problem and the fix, reducing a culture of blame and potential finger‑pointing and shortening resolution cycles.
For you as a client, that embedded model shows up as predictable release, more consistent on‑time delivery (OTD), and clearer visibility into how quality and operations are jointly managing risk across their programs.
Modern Warehousing and Materials Flow to Support Scale
Advanced injectable and biologic programs bring not only technical and regulatory complexity, but also significant warehousing and materials‑handling demands. When for example large GLP‑1 and other biologics programs came into the Philadelphia network, pallet counts and inventory profiles changed rapidly. The long‑term model for the site addresses that head‑on.
Key elements include:
- A dedicated modern warehouse footprint designed to handle much higher pallet densities and more dynamic inventory profiles, with validated cold chain capacity.
- Redesigned material flows that minimize non value added movement and double handling, reducing both damage risk and delays in staging lines.
- Scenario based planning to stress test how new programs, ramp ups, or SKU changes will affect storage, staging, and throughput before those changes hit the floor.
These changes have materially reduced product damage, eliminated complex pallet configurations, and made inventory location and status far more transparent to both operations and quality. For brand owners, the benefit shows up as more reliable starts, fewer warehousing-related delays, and reduced product loss.
Looking ahead, Philadelphia is planning for additional warehousing flexibility as new high‑volume programs are awarded, treating physical infrastructure as an integral part of the operating model for you as a client.
Line‑Level Discipline: Staffing and Changeovers as Strategic Levers
While structural changes get the headlines, day‑to‑day performance is still determined at the line level. Two design choices in Philadelphia have become particularly important best practices: a 12‑hour staffing model and systematic changeover optimization.
12‑hour shifts with stable crews
On key operations, the site moved from traditional 8‑hour patterns to structured 12‑hour rotations. Under the previous model, frequent overtime, mid‑week call‑offs, and fragmented schedules made it challenging to keep rooms fully staffed and drove significant labor cost. Today, teams work three 12‑hour shifts per week with four days off, in patterns designed to balance work‑life needs with operational coverage.
This change alone has sharply reduced overtime spending while providing employees with a predictable income pattern. The site has also seen reduced absenteeism and staff churn on the floor, resulting in more consistent staffing in critical rooms.
For you as a client, the tangible impact is more stable manning on critical lines, fewer last‑minute schedule changes, and improved throughput without sacrificing quality.
Changeover as a designed process
Philadelphia has also treated changeovers as an engineered process rather than a necessary nuisance. Cross‑functional teams from operations, engineering, and quality mapped typical changeovers step‑by‑step, asking what can be simplified, run in parallel, or better sequenced for efficiency. Roles are now clearly assigned during shutdown and startup, documentation work is front‑loaded wherever possible, and non‑value‑added steps such as redundant room blow‑outs have been removed where compliant to do so.
On some lines, this has reduced changeovers from eight hours to roughly two and a half, unlocking additional weekly capacity without the need for new capital investment. Combined with more thoughtful SKU sequencing and scheduling, the effect is a step change in effective capacity on high‑demand assets for you as a client.
A Governance Model That Brings the Business Unit to the Floor
Structural and line‑level changes are tied together by a governance model that keeps leaders close to where value is created. In each focus factory, tier‑1 and tier‑2 daily direction‑setting meetings take place on the shop floor, in shared “focus factory” zones where operations, quality, business, and engineering sit together. A tier‑3 senior leadership meeting manages escalations and cross‑factory trade‑offs.
This model has several benefits:
- Shared metrics and visual boards keep safety, quality, delivery, cost, and people performance visible to all functions, every day.
- Issues can be triaged and acted on in real time, with the right stakeholders already in the room or within a short walk.
- Performance governance is consistent across all three focus factories, so while operating models are tailored by technology, the way performance is managed is uniform.
Clients who visit the site now routinely see these governance forums in action, often walking through mock operating reviews that demonstrate how their programs are monitored and managed. The response has been positive, particularly from sponsors who experienced the site in its previous and more traditional operating state.
Building the Next Layer: Digital Tools and Lean Maturity
The current operating model is not static. Philadelphia is now focused on maximizing operational excellence, with a clear set of targets: on‑time delivery (OTD) consistently above 95 percent, batch record right‑first‑time (RFT) at or above 95 percent, and sustained adherence to safety and cost objectives.
Several forward‑looking initiatives are underway:
- Time out of refrigeration (TOR) digitization. The site is working toward software enabled, scan based TOR tracking to replace manual logs, improving compliance and freeing up operator and quality time.
- Electronic batch records (EBR). Building on pilots in the wider network, Philadelphia is preparing templates and system configurations to move key programs onto EBRs, with the dual goal of reducing batch record errors and providing near real time visibility to both operations and quality.
- Lean maturity through SQDCP. Using an SQDCP lens (safety, quality, delivery, cost, people), focus factories are defining the few metrics that matter most and using them to drive daily problem solving and A3 based investigations.
These initiatives are designed not as isolated tools, but as enablers that sit on top of the value‑stream structure, embedded quality, and line‑level discipline already in place.
What This Means for You as a Client
For brand owners managing complex portfolios across global networks, the details of any one site’s staffing model or warehouse layout matter only insofar as they improve outcomes. The Philadelphia operating model is explicitly built around those outcomes: reliable supply, predictable lead times, and consistent quality for advanced injectable, biologic, and traditional products alike.
Organizing around value streams ensures teams know your technologies and your business deeply. Embedded quality and integrated planning reduce late‑stage surprises and align all functions around shared goals. Modern warehousing and disciplined materials flow prevent capacity bottlenecks as programs scale. And line‑level staffing and changeover practices increase the productive time available on critical assets.
“For us, one of the most meaningful outcomes of this journey has been our clients’ trust. The next phase is about turning that trust into a durable competitive advantage for them, by making this operating model a repeatable standard for how complex packaging sites should run.”
