Norbert Schulze
Director Process Development Plasma @CSL
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WORK HISTORY
Director Process Development Plasma @CSL
EDUCATION
German Research Center for Biotechnology (GBF), Braunschweig
Doktor (Ph.D.)
Technische Universität Carolo-Wilhelmina zu Braunschweig
Master's degree
Ernst-Moritz-Arndt-Universität Greifswald
Prediploma
ABOUT NORBERT SCHULZE
I am a biotech industry leader with 20+ years of experience driving process development, CMC strategy, and global product launches. I have primarily focused my career on advancing plasma proteins, monoclonal antibodies, glycoproteins, and antibody-drug conjugates. In this work, I have consistently delivered innovations that improved yield, accelerated approvals, and secured regulatory success. I have partnered with senior executives and global regulators to bring therapies like AFSTYLA, RiaSTAP, and ZALTRAP/EYLEA to market while ensuring compliance, efficiency, and commercial scalability.I take pride in building bridges across development, engineering, operations, regulatory affairs, and quality to streamline launches and prevent delays. As a leader, I focus on empowering people, aligning strategy, and delivering measurable, strong bottom-line impacts. My expertise includes Quality by Design, continuous bioprocessing, facility design and GMP readiness, paired with a collaborative leadership style that earns trust at every level. I remain energized by opportunities to shape the future of biopharmaceutical manufacturing, expand connections, and contribute to innovations that improve global health.
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