Award Winner (PDA Europe Appreciation Award) 2024: Simone Biel

Simone Biel

Simone Biel

Merck KGaA, Darmstadt, Germany

I constantly move from one task to another in my daily work, striving to provide the best regulatory advice and shape good manufacturing practices in aseptic processing inside and outside my company. Uncertainty often arises regarding the right approach and the right balance between risk and benefit. Receiving this award allows me to pause and reflect on my professional and personal development, confirming that I am on the right path and supported by great people! 

“Receiving an industry award brings me even closer to PDA and its members, strengthening my collaboration with peers and facilitating exchanges with industry leaders. This collaboration helps me solve problems more effectively and broadens my perspective, fostering outside-the-box thinking. Engaging with diverse opinions encourages me to rethink decisions and approach challenges from new angles. 

Receiving an award elevates your presence within the industry, not just for yourself but also for the goals you are pursuing. It expands your network and fosters collaboration within the industry association, enabling all of us to collectively advance toward our shared objective: serving patients with life-saving medicines.

I am committed to driving Merck KGaA's mission of improving patient quality of life and contributing to a sustainable future through innovation in science and technology while ensuring regulatory compliance. This aligns perfectly with the theme of this year's PDA Good Aseptic Manufacturing Conference: “Excellence in Aseptic Manufacturing: Bridging Compliance, Innovation, and Sustainability.” Over the next months as Co-Chair of the conference, I will work diligently to bring together industry stakeholders, regulators, and suppliers, ensuring we are aligned on best practices and speaking a common language. I am inspired by people and diversity – working together and not against to each other.

About Simone Biel

Simone is a Senior Regulatory Consultant at Merck Life Science KGaA Darmstadt Germany specializing in Single-Use Technology and filtration in biopharmaceutical manufacturing.

Simone provides regulatory guidance to various stakeholders and has assisted numerous drug manufacturers in successfully implementing Single-Use Technology. Her primary goal is to ensure product performance aligns with quality and regulatory standards.

She is an active member of the Parenteral Drug Association (PDA) and holds a Ph.D. in Microbiology from the University of Frankfurt.