Robert Molzahn

Robert Molzahn currently serves as a Senior Specialist in CMC (Chemistry, Manufacturing, and Controls) at Excella GmbH & Co. KG, where he leverages his extensive regulatory expertise and scientific background to advance the development and compliance of Active Pharmaceutical Ingredients (APIs). In his role, Robert plays a pivotal part in designing and implementing robust API process development strategies that align with evolving global regulatory standards. His deep understanding of regulatory frameworks, such as ICH Q11 and ICH M7, enables him to lead critical projects focused on risk assessments for mutagenic impurities and nitrosamine contamination, ensuring that manufacturing processes meet stringent safety and quality requirements.

A key achievement in Robert’s career has been the successful integration of Quality by Design (QbD) principles into API process development, fostering a proactive approach to process understanding and control. This not only enhances product quality and process robustness but also streamlines regulatory submissions, facilitating faster market access. His expertise in risk management and impurity control—particularly through implementing impurity purge calculations—has significantly contributed to the company's compliance with GMP standards and regulatory expectations.

At Excella, Robert’s main tasks include serving as a specialist for API process development, providing strategic guidance on regulatory compliance, and supporting cross-functional teams in optimizing manufacturing processes. His skills in risk management, quality control, and research and development position him as a key driver in ensuring that API projects adhere to high standards of safety, efficacy, and regulatory adherence. Through his work, Robert continues to shape innovative solutions that meet industry challenges while maintaining a strong focus on quality and compliance in the pharmaceutical sector.