Thomas Kjeldsen Email & Phone Number

I have worked with commercial GMP manufacturing of drug substances (incl. upstream steps) for the last 7 years. The majority of the time with chemical manufacturing of small molecules, but also with downstream fermentation products. The first six years in direct contact with production, and the last year with oversight of CMOs. I am very data-driven in my work, where I have been working comprehensively with control strategies, process validation, scale-up, change management, continued process verification, and regulatory writing. Doing my work I especially like to design future-proof solutions by applying my process experience as well as my understanding of GMP and regulatory requirements (and the difference between the two) to think outside the box.Besides process chemistry I also have an interest in digitization, where I have also been working with designing and using relational databases, and applying software such as SAS JMP to connect, retrieve, and transform data to create automatic control charts. I have a keen interest in data spaces (data mesh), non-relational databases, machine learning, containerization, as well as digital twins.

Listed skills include Java, Xhtml, Microsoft Office, Microsoft Excel, and 12 others.