Following his recent promotion to GMP Validation Officer, we've asked Theodore to give us an insight into his experience, his new role and how he spends his time away from work...
What’s your background/experience to date?
I first got into GMP shortly after graduating from university, in July 2020. It was early in the COVID19 pandemic, and I was working at Oxford Biomedica, manufacturing the ChAdOx1 vaccine. It was a relatively steep learning curve with a new process for the company alongside my introduction to the industry, but I’m really proud of the work we did manufacturing well over 100 million doses.
I then moved to Adaptimmune to work as part of a relatively lean team setting up a new manufacturing site planned to manufacture an allogeneic platform to try and bring their oncologic therapies to more patients by reducing cost and reducing wait times. It really developed my understanding of what's required to get a facility up and running and involved a lot of cross-functional work which I now use in my current role.
Which brings me to CCTech. I joined in July 2024 and am leveraging a lot of my past experience in manufacturing, facility set-up and close work with our validation teams, supporting the qualification of our facility and equipment to support our clients with validation services and technical advice.
What does GMP Validation involve?
GMP validation, at its core, is setting out the requirements for a facility, process or piece of equipment and documenting and proving that those requirements are reliably met, and that a product can be produced which is consistently of the correct quality, attributes and is safe for the end consumer or patient. We offer quite a few different services, depending on what a client requires, from technical advice and guidance, to drafting a suite of validation lifecycle documents, including:
- User Requirements Specifications (URSs)
- Validation Master Plans (VMPs)
- Validation Plans (VPs)
- Design Qualifications (DQs)
- Installation Qualifications (IQs)
- Reports, and ‘wrap-around’ documentation for vendor supplied protocols
It's not all documentation, as we also execute installation qualifications at client sites, ensuring the facilities or equipment have been installed correctly, to the very exacting standards that GMP facilities need to meet, and we can witness vendor testing to ensure that testing is completed properly and compliantly. It's very varied, but fundamentally it's about ensuring that our clients’ facilities and equipment support the consistent, reliable delivery of safe products to their customers or patients.
What excites you about your role?
I think it’s two main things. The first is that our work is a core part of delivering some very innovative products to customers and patients or meeting a key unmet need. This is particularly on the Advanced Medicinal Therapeutic Products side of things, or in some of our NHS work supporting NHS trusts to develop the capacity they need to provide sterile products to patient populations. On a more personal level, the fact that we work with such a diverse range of clients means there’s always something new, novel ,interesting or challenging about the work we’re doing – which I think isn’t something you can experience, as easily, within a single department or company, where the focus might be on a specific type of manufacture, or a specific process. It’s also an opportunity to develop professionally across the breadth of what different companies are doing within the wider GMP industry.
What are your day-to-day activities/responsibilities?
On a day-to-day basis, my role predominantly consists of:
- Client meetings to identify and refine requirements, discuss updates and manage timelines and deliverables
- Documentation drafting and updates (for example the URSs, VMPs, VPs, etc)
- Liaison with vendors to discuss how they can meet a given client’s needs
At a slightly lesser frequency than the above, I also attend on-site visits with clients or am on-site executing or witnessing qualification and commissioning works for our clients.
What specialist software do you use (if any)?
We don’t currently work with a particularly significant specialist software, but we’re always looking at improving our processes and how we can use different software to support what we do.
And what’s your top tip around GMP validation?
If you define your requirements well, and early, and use specialist contractors or vendors with proven experience, you save so much more time and money than by rushing or trying to do things with the cheapest quoted service.
Away from work, what are your interests/pastimes?
Away from work I primarily enjoy gaming, walking and playing with our golden retriever, Pepper, and visiting National Trust properties with my partner (and the dog of course).