Sophie Sun
Senior Director, Head of Drug Product Development and Manufacturing @Zenas BioPharma
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WORK HISTORY
Senior Director, Head of Drug Product Development and Manufacturing @Zenas BioPharma
Waltham, MA, US
EDUCATION
Bowling Green State University
Master of Science (M.Sc.), Organic Chemistry
Fudan University
Bachelor of Science (B.Sc.), Chemistry
SKILLS
ABOUT SOPHIE SUN
Over 20 years of experience in the biotech and pharmaceutical industry, specializing in drug product formulation and process development, process validation (PPQ) and commercialization, technology transfer, biologic combination products, QbD, clinical and commercial manufacturing.• Proven track record of leading CDMO partnerships to deliver high-quality drug products, including subcutaneous biologic combination products.• Extensive experience in global regulatory submissions (IND, IMPD, BLA, MAA) and strategic leadership in drug product development from early phase through commercialization.• Deep expertise in sterile fill/finish, lyophilization, formulation, and analytical techniques. • Highly motivated and dedicated individual with strong work ethic, leadership, people management, and problem-solving skills.
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