Herbert Ogutu
Senior Manager, Contract & Development Manufacturing Amgen
Herbert Ogutu is a Contract Manufacturing Manager at Amgen, bringing extensive expertise across drug substance technologies, engineering, and tech transfer. At Amgen, he has held roles spanning Contract Manufacturing Manager (2021–present) and Senior Engineer within Drug Substance Technologies and Engineering (2019–2021). His background includes senior technical positions at ImmunoGen, AbbVie, and AstraZeneca, contributing deep experience in process validation and biopharmaceutical development. Herbert holds a Master’s in Biotechnology from the University of Wisconsin–Madison and a Master’s in Organic Chemistry from Iowa State University.
Seminars
Selecting and maintaining strong relationships with CDMO and regulator stakeholders is vital to navigate ADC manufacturing and supply chain in a timely, cost-effective and regulatory compliant manner to bring more accessible ADC therapies to patients in need.
Join this strategy-led workshop session to troubleshoot and optimize CMC stakeholder relationships to ensure ADC GMP quality and best set up regulatory submissions for success.
Workshop highlights include:
- Debating and navigating differences in opinion between industry and outsourcing partners at different stages of ADC manufacturing
- Understanding best strategies to optimize manufacturing stakeholder relationships and ensure ADC quality under GMP requirements
- Assessing best approaches for ADC regulatory submissions with discussion of science-based justifications to support alternative ADC control strategies
