The Essential Role Every Cell Therapy Team Should Have

Running a cell and gene therapy (C&GT) production facility is a complex task due to all moving parts, such as compliance, production, and release testing. This task become even more complicated when you add an R&D unit to the scene.

Because of this, as a C&GT supervisor, you would come to realize the only way to successfully run the facility is to be efficient at everything you do.

In C&GT facilities, the list of materials is very long, simply because every thing we use must be identifiable, traceable, and approved for use. Maintaining every item on this list is a real challenge, and if not carefully planned, the results can be detrimental. 

One approach to keep material in order, is to assign a member of the team to be the “go-to” person for everything material, for this post we will call this role a “material specialist”.

By assigning a team member to the material specialist role, they are given a set of responsibilities:

• Monitor the material stock
• Alert leadership of material shortage
• Receive material and get them approved for clinical use
• Identify material, prepare their specification sheet, and get them approved
• Ensure stock of material covers the planned production runs

For the material specialist to efficiently perform their responsibilities, they need to dedicate more time for office work. Further, material specialist need to be authorized to:

• Place orders, and communicate them to central material management
• Lead activities to stage for clinical production

By having a material specialist on the team, you may enjoy longer breaks, correct? Wrong. This role does help you by freeing more time of your schedule for critical tasks, but there are more to it:

1. Provides the team member with the opportunity to grow by assuming a leading role.
2. Prepares a second person that can provide reliable material information to leadership.
3. Provides the rest of the team with a go-to person, besides you.
4. The facility activity would not be interrupted by your absence during your vacation or external assignment.

• The go-to person approach would easily apply also to equipment and facility. Utilize it fully to achieve the highest efficiency.
• This assignment approach applies to almost every laboratory and not only C&GT facility.
• The go-to persons on your team can cross-train each other on the essential parts of their roles, this way you extremely minimize the risk of not having expertise of any area.

I enjoyed this approach as a supervisor, and I am sure you will find it helpful too.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us. 

About the author

Naseem Almezel, earned his MSc degree in Cellular Therapies in 2010, since then his career focus is to support Bone Marrow Transplant and Oncology programs. Naseem likes to work in the lab doing translational research, or in the cleanroom doing GMP production. When he is not working, Naseem likes to read and to spend time outdoors. Find more about Naseem here