Integrity and transparent communication are crucial values, fundamental to the interactions between a CDMO and its customers. They ensure efficient, effective, and phase-appropriate project management throughout the life cycle.
A Small Company Culture with Large Company Resources
Grace Fine Chemical Manufacturing Services (FCMS) ) is uniquely positioned in the Pharma business within the Materials Technologies division of W. R. Grace & Co. — a global organization with approximately $1.7 billion in revenue and more than 4,000 employees — that provides contract development and manufacturing services to the pharmaceutical industry and other specialty chemical sectors.
With two production sites, Grace FCMS operates with the mindset of a small company. FCMS is a tight-knit community within the company, with open, direct communication between all levels of the organization. Our general manager and senior management are highly interactive with the production sites, engaging freely with all team members, not only about their jobs and where they would like to see improvements, but also about their personal lives and well-being.
The compact structure and collaborative communication make FCMS highly flexible and nimble, so we can align our activities closely with those of our pharma customers. As such, we behave like a small company — but with access to the funding and resources of a large, global corporation.
Care, Collaboration, Integrity, and Transparency
Constant open communication leads to tremendous cohesiveness within FCMS. Each customer project is supported throughout its life cycle by a cross-functional team that includes the program manager and representatives from R&D, quality, analytical, engineering, and any other relevant departments. The members of these close-knit teams are in constant communication with one another, so they understand what each participant’s role is and how they can support each other.
Customers are encouraged to include their technical experts in our project teams. We rely on our customers to share their product and process knowledge with our team so that we can move all projects forward through the development cycle as quickly as possible. This approach fosters transparent communication and collaboration, which are essential to success for both Grace FCMS and our customers.
Transparency is just one of the values that drives the culture Grace FCMS. Talent, Technology, and Trust also underlie our quality performance, informing and guiding what we do, how we communicate and how we work through process scale-up issues. Incorporation of these fundamental attributes within our project teams guarantees that they operate smoothly.
The members of our project teams understand that the processes they are developing will impact patients, including members of their own communities. At Grace FCMS, we recognize that establishing a clear and open line of communication among our teams and our customers is essential to prepare for and address challenges, without disrupting the timeline or failing to achieve our collective goals. We work diligently to establish an environment in which everyone’s opinion is respected, and all voices are welcomed to help us develop optimal solutions.
Balancing Curiosity and Customer Expectations
Curiosity is another prerequisite for success. Our scientists at FCMS demonstrate endless curiosity and pursue the greatest possible depth of understanding about our customers’ programs; beyond the science, they also recognize the importance of meeting customer expectations regarding cost and timelines. The result is phase-appropriate research and development work specifically tailored to the needs of each individual project and customer.
In some cases, customers are interested in gaining greater process understanding early on and are willing to invest additional time at the beginning of a project. However, in cases where timelines are short, our R&D teams will often conduct experiments during scale-up that provide additional process understanding and information that may be crucial when moving to commercial production, without extending the project timeline.
For all projects, scale-up efforts are focused on ensuring long-term success at commercial scale. At our South Haven, Michigan site, we can perform runs at the lab (up to 100 L), pilot plant (up to 500 gallon) and commercial (up to 4000 gallon) scales. Throughout the process development and optimization stages, we keep in mind that eventual commercial production is a key objective. We design processes for practical implementation under GMP conditions and anticipate and address potential issues that might arise as a project progresses.
The culture of trust that exists at FCMS is highly valued by all employees. Grace FCMS continuously fosters a supportive environment across both manufacturing sites. Underlying this effort is the recognition that we are all working to improve and extend the lives of patients. Having that objective in mind helps to clear out any barriers and encourages understanding and trust between and within groups.
Prioritizing Safety and Quality
The culture at Grace FCMS also drives our commitment to safety and quality, which are our top priorities and ingrained into everyday activities. Establishing and meeting high safety and quality standards is essential to our success, and these talking points are woven consistently into every aspect of our operations. They are designed into processes from the outset. Our quality and safety groups have a large presence on the plant floor, and operators are trained to maintain quality consistency and identify any potential risk points.
Management is proactive in developing and discussing safety and quality initiatives and identifying areas for improvement.