We spoke with Karol Speight about the dynamic and challenging field of biopharma forensics.
Karol Speight, an EU supplier relationship manager at biopharma Amgen, is currently working in forensic analysis and defects creation, with the process development and commercial attribute sciences team at Amgen ADL.
“Whenever a batch of medicine is produced, it undergoes a rigorous inspection process through an automated visual inspection system,” he explained to SiliconRepublic.com.
“This approach ensures that all products attain the highest quality standards and comply with regulatory requirements. As part of the overall investigation process, the forensics and defects lab identify foreign matter, classify defects, create and manage defect sets to train inspectors, and challenge the automated visual inspection systems pre or post-inspection activities.”
But how did he begin his career in such a dynamic and rapidly changing space?
How did you find yourself gravitating towards this role?
I started my career as an analyst at a component manufacturing facility. However, I did a primary degree in biopharma manufacturing and this is where my passion lay. So, I studied pharma technology part-time while working. Pursuing further education meant that when I joined Amgen, I was up to speed with the manufacturing processes associated with a fill-finish facility.
I’ve been with the company over nine years and during that time, I’ve been fortunate to collaborate with teams in the US and the Netherlands. Now with more people joining my team, I’m focused on sharing my knowledge and acting as a mentor. Supporting my colleagues, helping the newer staff members in the team to build their own analytical expertise and network as we look to grow and develop the team is hugely rewarding.
Have there been any exciting or interesting breakthroughs in your field recently?
3D imaging and user-friendly benchtop forensics equipment are evolving at a rapid pace. The deployment of these cutting-edge technologies support faster turnaround times on forensics results. They also mean that the capabilities that identify foreign matter like particles have become more advanced and they may lead to the development of more adaptive isolation techniques.
Ultimately, these technological breakthroughs have the potential to support faster turnaround times and give an added level of information to aid the final analysis result. With the rapid adoption of AI, there are many opportunities to help the team to work smarter, identify trends and deliver continuous improvement.
What technologies and skills do you leverage to propel your research forward?
While cutting-edge technology supports our work, having the appropriate skillset is just as important. A science degree and lab experience are prerequisites for working in forensic analysis and it’s also advantageous to have a manufacturing, QA or QC background.
In addition to these foundational skills, being technically adept and possessing the necessary concentration levels to do highly complex, analytical work are vital. Most importantly though, the ability to forge strong relationships with the team and our subject matter experts and colleagues in other sections of the business, is key because we work in a highly collaborative environment.
What challenges are impacting the forensics space and how are they overcome?
Forensics is a very broad space that incorporates many different scientific areas including chemistry and physics, so there can be an expectation that you know all the answers. It is a highly collaborative space, where advice and guidance from other network contacts help to piece together the puzzle that delivers a solid conclusion based on the available information.
Our work also goes through peaks and troughs, there are periods where batches attain acceptable quality limits or right first time. In other instances, a batch needs to be shipped urgently and is waiting for our lab to complete an investigation before sign-off can be completed by quality. A cool head and attention to detail always prevails, especially when we feel like we’re the ones under the microscope.
Are there any misconceptions about forensics?
The nature of the work is very complex and there can be expectations that we get a solid read out every time, when this is the exception rather than the rule. It means that there is a need to educate people about the intricacies of our work and the time it takes to provide a definitive answer. As time is always limited, it is important to pre-empt subject matter experts’ engagement and to streamline report times by ensuring pertinent information is pulled together and reported quickly. This approach supports efficient analysis and ultimately, it means that batches of medicine can be released on schedule.
Have you any advice for people looking to start their career in forensics?
It’s a very interesting, rewarding career, especially when you lead an investigation from start to finish and determine a path forward where previously there was a roadblock. You’ll need an ability to apply high levels of concentration over extended time periods and to think objectively to find a clear result. It’s also important to bring all stakeholders together and to collaborate with relevant subject matter experts and the toxicology and medical evaluation teams. Cultivating these relationships is key to a successful career in forensics.
What do you predict for the future of the sector?
Technology will drive the sector forward and help to further streamline our processes. That said, there will always be a need for experienced forensics professionals who can make informed determinations, so an analytical mindset and attention to detail will be fundamental to forensics in the future.
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