Ying
Executive Director, Manufacturing Sciences and Technology at Ultragenyx
- Role
- Executive Director, Manufacturing Sciences and Technology at Ultragenyx
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Ying
Extensive industry experience in the early and late stage pharmaceutical development and manufacturing of complex biologics. Proven track record of regulatory filings for AAV gene therapies, KEYTRUDA, Serum-free Avonex, Plegridy, Alprolix, Eloctate, etc.• Broad technical knowledge of different modalities including AAV, pDNA, oligonucleotides, antibodies, antibody conjugates, and fusion proteins.• Core competencies include process development, DOE, multivariate modeling, process validation (PPQ), Continued Process Verification (CPV), analytics, cGMP compliance, quality risk management, biologics manufacturing, regulatory filings, CMC strategy, and leading cross-functional teams.
Experience
Executive Director, Manufacturing Sciences and Technology
Feb 2022 — Present · Bedford, MA, US
Head of Manufacturing Sciences and Technology for gene therapies. CMC team lead.
Education
Zhejiang University
BS, Biochemical Engineering
University of Arkansas
PhD, Chemical Engineering
2000 — 2004
Skills
- Vaccines
- Biotechnology
- Protein Purification
- Process Characterization
- Chromatography
- Process Validation
- Technology Transfer
- Gmp
- Standard Operating Procedure (Sop)
- Validation
- Biochemistry
- Purification
- Dna Vaccines
- Process Performance Qualification
- Project Management
- Biopharmaceuticals
- Gene Therapy
- Protein Chemistry
- Fermentation
- Process Development
- Sop
- Continued Process Verification
- Molecular Biology
- Process Simulation
- Cgmp
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