Samsung Biologics appoints new leadership to oversee quality and regulatory affairs

– Distinguished industry leaders with extensive track records in quality assurance and regulatory affairs join Samsung Biologics to support the company’s quality-driven business operation.

INCHEON, South Korea, Aug. 24, 2023 /PRNewswire/ — Samsung Biologics (KRX: 207940.KS), a global contract development and manufacturing organization (CDMO), today announced the appointments of Gail Ward as Executive Vice President and Head of the Quality Center, and Sojeong Lee as Vice President and Head of Regulatory Affairs.

A seasoned pharmaceutical executive, Ward has almost four decades of extensive quality experience in both large pharmaceutical companies and entrepreneurial biotech companies. Prior to joining Samsung Biologics, Ward served as Head of Quality at ProKidney Corporation, a late clinical-stage biotech company specializing in treatments for chronic kidney disease. Her experience also includes quality assurance leadership roles at Celltrion, and senior positions at Diosynth RTP and Biogen.

Samsung Biologics also appointed Sojeong Lee as the Vice President and Head of Regulatory Affairs to oversee and manage the company’s response to and relationship with global regulatory agencies. Prior to this role, Lee served as the Regulatory Affairs Director at GlaxoSmithKline in Korea.

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated, end-to-end CDMO service provider, offering seamless development and manufacturing solutions from cell line development to final aseptic fill/finish as well as laboratory testing support for the biopharmaceutical products we manufacture. Our state-of-the-art facilities are cGMP compliant with bioreactors ranging from small to large scales to serve varying client needs. To maximize our operational efficiency and expand our capabilities in response to growing biomanufacturing demands, Samsung Biologics fully completed Plant 4, which will further advance the company’s standing as the world’s largest manufacturing facility at a single site—holding a 604KL total capacity—and announced plans to construct Plant 5, which will be operational in April 2025. Additionally, Samsung Biologics America enables the company to work in closer proximity to clients based in the U.S. and Europe. We continue to expand our capabilities to accommodate our clients by investing in technologies such as an antibody-drug conjugate (ADC) facility, a dedicated mRNA manufacturing facility, and additional aseptic filling capacity. As a sustainable CDMO partner of choice, we are committed to on-time, in-full delivery of the products with our flexible development and manufacturing solutions, operational excellence, and proven expertise.

Samsung Biologics Contact
Claire Kim
Head of Marketing Communication
[email protected]

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