Yuval Shimoni
- Role
- Associate Director, Product Quality Leader at BioMarin Pharmaceutical Inc.
- Location
- Berkeley, CA, US
- LinkedIn followers
- 500 followers
About Yuval Shimoni
Extensive experience in the biotech industry (established and startup): Research…
Experience
Associate Director, Product Quality Leader
Dec 2021 — Present
Provide technical quality leadership in partnership with cross-functional stakeholders to develop and execute program strategies that ensure product quality, manage risks and support CMC objectives\\\\n• With a diverse portfolio consisting of two commercial and two clinical products (including biologics and small molecules), I manage quality deliverables (e.g, regulatory submission related commitments and responses to questions from health authorities) for CMC through leadership of (four) product-dedicated Quality Partner Teams\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Education
Weizmann Institute of Science
PhD
1992 — 1997
The Hebrew University of Jerusalem
BSc
1986 — 1990
Weizmann Institute of Science
MSc
1990 — 1992
Skills
- Biotechnology
- Process Development
- Cell
- Biochemistry
- Cross-Functional Team Leadership
- Regulatory Affairs
- Cell Culture
- Validation
- Gmp
- Chromatography
- Cell Biology
- R&D
- Purification
- Process Validation
- Technology Transfer
- Glp
- Molecular Biology
- Fermentation
- Commercialization
- Research and Development (R&D)
- Fda
- Monoclonal Antibodies
- Process Simulation
- Assay Development
- Biopharmaceuticals
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