A Day in the Life of a Specialist in Biological Analytical Methods

The Day in the Life of series continues with a spotlight on those in the R&D side of things in pharma, a key element to medicine discovery, safety, and manufacture. This interview shines a light on those working in this integral field. 

Please could you outline your background and the career path that has led you to your current position?

I majored in Genetics and Experimental Biology. During my studies, I became particularly interested in microbiology, which led me to begin an internship in a microbiology laboratory at the university. I later continued my research at the Polish Academy of Sciences, where I worked with bacteriophages. I also had the opportunity to work with archaeal viruses during an Erasmus programme in Dresden. Work on vector ligation, optimisation of transfection, adjusting conditions in bacterial expression systems, and attempts to obtain protein crystals taught me critical thinking and the ability to draw conclusions from a wide range of experimental outcomes, regardless of the result. When I moved into my current role, I found myself stepping into a new professional environment, which was both challenging and rewarding. Working in the Research and Development Department and transitioning into an analytical role proved to be especially fulfilling, allowing me to expand my expertise and apply my scientific background in new ways.

What would be the perfect start to your day?

My perfect morning – especially in winter – includes a hot cup of water infused with cinnamon and ginger. This is usually followed by a short yoga session to keep my spine in good condition; anyone who spends long hours in the lab knows how demanding it can be on the back if you do not stay active outside of work. No morning would be complete without a cup of coffee. I also like to solve a few Sudoku puzzles to relax my mind before taking on the day.

Could you describe the most challenging or interesting day in your career so far?

One of the most exciting days for me was the first time I hosted students visiting our headquarters. Each year, we invite students to show them what working in the biotechnology sector looks like in practice; being their guide in the R&D Department gave me a completely new perspective. I was impressed by their curiosity and genuine enthusiasm. That experience reminded me that many tasks that feel routine to me are fascinating to others seeing them for the first time. It made me appreciate my work and its impact even more.

What do you most like about your role?

What I like most about my role is that it encourages creativity. As I mentioned earlier, I enjoy solving puzzles, such as Sudoku, and I often think of method development as a real-life version of one. You solve one problem and find one missing piece only to realise there are still many others to uncover. Finding those solutions requires patience, logical thinking, and creativity. Sometimes the approaches you test turn out to be incorrect, but that is part of the process. You learn from each challenge and continue searching for the right path. The most rewarding moment is when everything finally comes together (but just for a minute; quickly afterwards I find myself looking for another challenge).

What inspired you to get into your field in the first place?

I was motivated by the desire to make a difference. Working with biological drugs, especially at the early stages of their development, gives me a sense of contributing to public health improvement. Also, I always knew that I wanted to be involved in research and development, as it allows me to apply scientific thinking while giving space to creativity and problem-solving.

What would you consider your biggest achievement to date, what are you most proud of?

My biggest achievement to date was giving a talk at the BEBPA 2024 European Bioassay Conference on the development of orthogonal techniques for dual-binding assessment using the AQbD approach. At the time, this project was particularly challenging, as it was my first experience working with bispecifics. There were many ups and downs along the way, but with the support of my manager, Paulina, and my colleague Marcin, who collaborated closely with me on this project, we successfully achieved our goals. Presenting our work to an audience I deeply respect was an incredible honour and a defining moment in my career.

Do you have any further career aspirations? What do you think your next steps will be?

I would love to work with many more different types of product. In relative binding assays, each new product usually means developing a new binding method, and I’m eager to deepen my expertise in the methods I create. I’m also keen on expanding my experience in orthogonal methods development for assessing the same attribute. So far, I’ve collaborated with specialists on orthogonal techniques, but in the future, I’d be excited to take at least a partial role in developing both (or even multiple) techniques myself. It would also offer an excellent basis for future conference presentations.

What do you see as the next big opportunity in your sector?

From my perspective, the next major opportunity, but also a challenge will be how the industry responds to the EMA’s reflection paper on a tailored strategy for biosimilar development. By allowing the possibility of skipping phase III clinical trials, which may improve biosimilar availability while significantly reducing costs, greater emphasis must be placed on the early stages of development. Although still in draft form, this document highlights the importance of the initial phases of product development, where the Research and Development sector plays a crucial role. Carefully planned method development based on AQbD principles, the use of orthogonal techniques, and similarity assessment protocols designed to address potential differences will be demanding, but also offer an excellent opportunity to explore and adopt new solutions.

When you were younger, want did you want to be when you grew up?

I wanted to become a musician. I always loved singing and during primary school I started playing the acoustic guitar, which I later swapped for an electric one. Although I eventually stopped playing the guitar, I still enjoy singing from time to time.

Bio

Natalia Wojnowska is a Specialist in Biological Analytical Methods at Mabion Biologics CDMO, with a strong scientific background in ligand-binding assays and biological analytics. Her work focuses primarily on the optimisation and verification of analytical assays in accordance with ICH and USP guidelines. As a member of the Analytics Development Division, she contributes to analytical method development while also coordinating laboratory activities and supporting cross-divisional communication within project teams. Her hands-on expertise includes ELISA both for potency and content determination, Surface Plasmon Resonance (SPR), and other ligand-binding techniques. She has experience working with antibody–drug conjugates, bispecific antibodies, biosimilars, and protein-based therapeutics. Her professional interests include regulatory aspects of analytical development.