Marieke Zhao
VP, CMC Biologics
- Role
- VP, Cmc Biologics at Syner-G
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Marieke Zhao
Senior leader with extensive experience in bio-therapeutic development, including drug substance process development, technology transfer, process scale-up, CMO selection and management, CMC strategy, and regulatory filings. Excels at facilitating collaboration of research, preclinical, CMC, and clinical development teams with a track record of ushering novel Biologics from pre-development to first-in-human clinical trials with aggressive timelines.
Experience
VP, Cmc Biologics
Jan 2025 — Present · Boston, MA, US
CMC technical and regulatory support for clients in the Biologics field• Provide guidance to clients in all areas of CMC development, including cell line development, drug substance and drug product process and analytical development, process validation, CDMO selection and management, and authoring of early and late-stage regulatory filings
Education
Boston University
Post-doctoral fellow
North-West University / Noordwes-Universiteit
Master of Science (M.Sc.), Biochemistry
North-West University / Noordwes-Universiteit
Bachelor of Science (B.Sc.), Biochemistry
University of Zurich
Ph.D, Molecular Biology
Skills
- Ind Writing
- CMO Management
- U.s. Food and Drug Administration (Fda)
- Pharmaceutical Industry
- Protein Expression
- Cho Expression Systems
- Cross-Functional Collaborations
- Cmc Team Lead
- Life Sciences
- Antibodies
- Antibody Drug Conjugates (Adc)
- Cell
- Technology Transfer
- Ind
- Molecular Biology
- Drug Development
- Cell Line Development
- Biopharmaceuticals
- Drug Discovery
- Cell Biology
- Cell Culture
- Protein Chemistry
- Oncology
- Gmp
- Cross-Functional Team Leadership
- Biotechnology
- Developability Assessments
- Research and Development (R&D)
- Monoclonal Antibodies
- Assay Development
- Project Management
- Elisa
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