Sterling Snapshot | Catherine Milton, Operations Technical Specialist

Catherine Milton joined Sterling’s Deeside site in December 2021. In her role as Operations Technical Specialist, Catherine is responsible for the introduction and qualification of new process equipment and completing feasibility and material of construction assessments.

Can you briefly describe your background and education?

I graduated from Aberdeen University with a degree in Immunology and Pharmacology, and a masters in Drug Discovery. Once my studies were complete, I joined an organisation called EnteroBiotix as a Healthcare Scientist, where I worked for two years. In this role I spent most of my time supporting the company in securing a GMP licence at the facility.

I then moved to Wales to work at Sterling’s Deeside site as a Manufacturing Technician. As part of this role, I was responsible for the cleaning of production areas and maintenance of equipment to ensure the cleanroom was always ready for the production of antibody drug conjugates (ADCs). I was responsible for the manufacture of client ADCs and documenting the process to a GDocP standard. Outside of the cleanroom, I would support the creation of documentation such as SOPs and Batch Manufacturing Records.

After two years as a Manufacturing Technician, I was offered the role of Operations Technical Specialist which is the role I am in today.

I also have experience working in the quality assurance department as a Validation Associate, where I was seconded for eight months before returning to my original role.

Can you tell us what your role as Operations Technical Specialist involves?

My role involves working with the process development (PD) department to confirm the process being worked on can be scaled up to our manufacturing facility. This is done by completing feasibility assessments, FMEA’s and material of construction assessments.

Once a project is deemed feasible in the facility, we must ensure we have the correct equipment, and it is up to date on the maintenance and calibration schedule. I am also responsible for the introduction and qualification of new equipment that is required for the project. We must ensure that all staff are trained accordingly so they have the required knowledge and skills to conduct the process safely.

I also work to create and develop documentation including batch manufacturing records, specifications, validation protocols and reports, and COSHH assessments. Alongside this, I am responsible for ensuring the timelines set are achievable and must attend client meetings as a manufacturing representative to confirm this.

How does your role support our customers?

My primary duty is to make sure the customers’ product is made in a timely fashion. Once we are given a time frame from the project manager, it is my job to ensure the consumables, materials and equipment, can be produced and prepped on time to meet this need, as well as working on documentation such as batch records, specifications, and process flow diagram to ensure the batch is proceedable.

How important is collaboration in your role?

I work with a variety of departments across the Deeside facility, bridging the gap between colleagues to help create an effective line of communication. I work alongside the PD department to ensure the project presented is achievable within our facility.

I also work with other departments such as environment, health and safety.This involves reviewing the proposed process and identifying any potential safety risks, which primarily revolves around containment of the toxin used to make ADCs. I provide a line of communication between departments to discuss sample plans and to assign resources between the teams during batch manufacturer.

What is your favourite part of working at the Deeside facility?

The people. Everyone who works here is so friendly and always happy to help. I enjoy having the opportunity to get to know and collaborate with a variety of people across many departments at the facility.

I appreciate how no two days are the same in my role. There is always an exciting project to work on and new tasks to tackle each day which I find creates a satisfying and fulfilling workplace.