Sophie Sun

Senior Director, Head of Drug Product Development and Manufacturing @Zenas BioPharma

Lexington, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2024 — Present

Senior Director, Head of Drug Product Development and Manufacturing @Zenas BioPharma

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Waltham, MA, US

EDUCATION

N/A

Bowling Green State University

Master of Science (M.Sc.), Organic Chemistry

N/A

Fudan University

Bachelor of Science (B.Sc.), Chemistry

SKILLS

Drug DevelopmentBiopharmaceuticalsCROBiotechnologyDrug DiscoveryOrganic SynthesisHigh-Performance Liquid Chromatography (Hplc)GmpSpray DryingCMO ManagementPharmaceutical IndustryFdaPreformulationValidationPharmaceutical Process DevelopmentLyophilizationSolid State CharacterizationU.s. Food and Drug Administration (Fda)Technology TransferFormulationChromatographyLife SciencesHplc

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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Sophie Sun — Senior Director, Head of Drug Product Development and Manufacturing at Zenas BioPharma in Lexington, MA, US | Unifers