Michael Ong
Sr. Director Manufacturing, CMC, Biologics Development, and Outsourcing
- Role
- Senior Director Manufacturing at Candid Therapeutics
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Michael Ong
Accomplished in biologics CMC development, manufacturing, and project management. Skilled at protein purification, bioconjugation, technology transfer, manufacturing, and analytical method development.CMO management: cell banking, drug substance (upstream and downstream) and drug product manufacturing. Review process development, tech transfer, batch records, analytical methods development and qualification protocols, Participate in investigation and resolution of manufacturing deviations. Review and manage DS and DP stability programs.Draft and review CMC relevant modules of CTD.Manager of GMP downstream operations.ADC process development and manufacturing.
Experience
Senior Director Manufacturing
Dec 2024 — Present
Education
UC San Diego
Bachelor's, Microbiology
1982 — 1987
Skills
- Bioconjugation
- Monoclonal Antibodies
- Uv/Vis
- Assay Development
- Adcs
- Biochemistry
- Ind
- Elisa
- Start-Ups
- Life Sciences
- Lifesciences
- Purification
- Chromatography
- Drug Development
- Biopharmaceuticals
- Biotechnology
- Protein Purification
- Protein Chemistry
- Pharmaceutical Process Development
- Clinical Development
- Bioconjugate Chemistry
- Microbiology
- Small Molecules
- Gmp
- Technology Transfer
- Uf/Df
- Antibodies
- Peptides
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