Joseph Jerkins

Placeholder Person Graphic
Genentech
Senior Director, Drug Substance Make, Assess, Release
Joe Jerkins is the Senior Director and Chapter Lead of Drug Substance Make, Assess, Release (MAR) at Genentech in South San Francisco. In this role, Joe leads a team responsible for the Quality oversight of manufacture, testing and release of GMP clinical products, including Biologics cell banks and drug substances, as well as, synthetic molecule APIs. His team members also serve as the Quality single point of contact (QSPOC) on early stage clinical development (CMC) projects and determines batch disposition for clinical trial material from cell bank through final labeled finished goods. Additionally, Joe serves as the Global Drug Substance Fleet Quality owner for Roche.

With over 20 years at Genentech, Joe has held various leadership positions across different facets of the organization. His experience spans Global Quality Systems, Quality Assurance, Operational Excellence, Cell Culture, Fermentation & Media Prep Production Operations.

Joe holds a Bachelor of Science in Industrial and Operations Engineering from the University of Michigan and a Master in Business Administration from Boston University.

Related Articles

The Power of Fleet Management in Distributed Manufacturing
Technical
The Power of Fleet Management in Distributed Manufacturing
The pharmaceutical industry faces significant challenges in rapidly expanding production capacity to meet the needs of patients. Traditional centralized manufacturing models are increasingly seen as inflexible and slow to adapt to the dynamic demands of modern healthcare. This article proposes a regulatory framework for distributed manufacturing using the concept of fleet management to address...