Joseph Oh

About Joseph Oh

A biotechnology professional with 22 years of experience (11 years in managerial roles) in practicing current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) in compliance with the Code of Federal Regulations (CFR) Title 21 Part 11/210/211 and European Union (EU) GMP Annex, including 9 years of international experience in management roles for working with contract manufacturing organizations (CMOs) in Korea • Possession of successful records of managing and participating in regulatory agency inspections such as Pre-approval inspections (PAI)/Pre-license inspections (PLI)/GMP inspections conducted by the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) • Experience in development of clinical stage products leading to commercial launch as Quality, Manufacturing Operations and CMC (Chemistry, Manufacturing and Controls) for various biologics and small molecule product types (monoclonal antibody/ Escherichia coli fermentation/ microbiome and organic-synthesis-based small molecule)• Experience in working with the entire stages of cGMP aseptic manufacturing process covering from raw material receipt and inspection management, manufacturing, testing to final product disposition, in both clinical and commercial manufacturing environments under various production scales (from 25 L to L)

Experience

1. Director of Quality Operations

   Keros Therapeutics

   Apr 2024 — Present

Education

• UCLA

  Bachelor of Science (BS), Chemistry

Skills

• 확인
• Deviation Investigation Trainer
• 변경통제
• 제약
• Sop
• Fda
• Capa
• 품질시스템
• 생명공학
• QA
• Deviation Investigation
• Gmp