Janet Chung

About Janet Chung

I’m a CMC leader with a passion for transforming breakthrough science into medicine. With extensive experience across research, development, manufacturing, and supply chain, I specialize in advancing cell and gene therapies (CGTs) from discovery to clinic.My journey began at City of Hope, where I engineered HIV resistance in autologous CD34+ HSPCs using RNA-based lentiviral vectors. Through vector optimization, I achieved a 100-fold improvement in packaging and over antiviral potency across multiple HIV strains. This foundational work underscored the importance of designing scalable, GMP-compliant bioprocesses to bridge innovation from bench to bedside.Since then, I’ve built and led analytical and process development functions at both emerging biotechs and large biopharma, establishing internal capabilities and support tech transfer into GMP manufacturing environments. I’ve had the privilege of shaping viral vector platforms and building labs and teams from the ground up.To broaden my impact, I pivoted into CMC operations—managing programs from IND to BLA. At Decibel Therapeutics, I led the CMC strategy for DB-OTO, our AAV-based gene therapy to treat deafness in children, driving it from preclinical to first-in-human trial (CHORD). I oversaw end-to-end clinical supply chain and CDMO/CRO partnerships, and later supported post-acquisition integration with Regeneron, accelerating the program’s path to BLA. Seeing patient data and the restoration of hearing was a profound reminder of why this work matters. I\'m currently exploring new opportunities to leverage my CMC development and bioprocessing expertise to bring transformative therapies to patients. If you\'re looking for a passionate scientist and strategic leader who thrives at the intersection of science, manufacturing, and clinical translation—let’s connect.Areas of expertise- Gene Therapy (AAV + LVV)- CMC Strategy- Bioprocess Development- Tech Transfer- Manufacturing- CDMO/CRO Management- Project Management

Experience

1. Cmc Project Manager (Consultant)

   Tvardi Therapeutics

   Sep 2025 — Present

   Lead small molecule product development strategy and end-to-end supply chain operations to achieve uninterrupted drug supply and zero stockout for clinical studies

Education

• The University of Texas at Austin

  BS, Chemical Engineering

• University of California, San Francisco

  Ph.D., Chemistry and Chemical Biology

Skills

• Northern Blotting
• Cell-Based Assays
• T Cells
• Western Blotting
• Microscopy
• Protein Chemistry
• Drug Design
• Biochemistry
• Assay Development
• Gene Therapy
• Lentiviral-Mediated Gene Transfer
• In Vivo
• Drug Discovery
• Chemistry
• Elisa
• Nmr Spectroscopy
• Pcr
• Genomics
• Small Animal Models
• Cell Culture
• Tissue Culture
• Flow Cytometry
• Mammalian Cell Culture
• Biotechnology
• Protein Purification
• Stem Cells
• Rna
• Cloning
• Dna
• Purification
• Protein Expression
• Hiv/Aids
• Molecular & Cellular Biology
• Structural Biology
• Biophysics