Keith Life
Site Head Manufacturing at BioMarin | San Francisco Bay Area
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Keith Life is a seasoned biotech executive with over 25 years of comprehensive experience in the industry, specializing in manufacturing, engineering, and large-scale project management. Currently serving as the Site Head of Manufacturing at BioMarin’s Novato facility, Keith oversees four state-of-the-art manufacturing plants dedicated to producing both clinical and commercial products, including cutting-edge gene therapies and enzyme replacement therapies. In this pivotal role, he is instrumental in harmonizing and standardizing manufacturing operations across these facilities, driving initiatives aimed at optimizing process efficiencies, reducing costs, and ensuring compliance with stringent regulatory standards such as FDA regulations and 21 CFR Part 11.
Keith’s expertise encompasses validation, process simulation, and technology transfer, which are critical to maintaining the integrity and quality of biopharmaceutical products. His leadership in implementing robust quality systems and CAPA processes ensures continuous improvement and adherence to Good Manufacturing Practices (GMP). With a deep understanding of quality assurance, process validation, and regulatory compliance, Keith has successfully led complex projects that enhance manufacturing scalability and product consistency. His strategic focus on team building and cross-functional collaboration fosters a culture of innovation and operational excellence.
Through his extensive industry experience, Keith has developed a keen ability to navigate the challenges of biotech manufacturing, leveraging his skills in SOP development, process optimization, and quality system management to support BioMarin’s mission of delivering transformative therapies. His leadership not only ensures the reliable production of life-changing medicines but also positions the Novato site as a benchmark for manufacturing excellence in the biotech sector.
Site Head Manufacturing at BioMarin in February 2021 to Present
Sr. Director Gene Therapy Manufacturing at BioMarin Pharmaceutical Inc. in September 2018 to February 2021
Director of Viral Vector Production at BioMarin Pharmaceutical Inc. in July 2016 to February 2021
Director of BioTechnology at Versa Engineering & Technology in January 2015 to July 2016
sr. consultant at genentech in January 2007 to January 2015
Sr. BioTech Consultant at V2 Bio Consulting in January 2007 to January 2014
VP Operations at Isolagen UK in January 2004 to March 2007
Director of UK Operations, Medimmune, Liverpool, England (1999 – 2004) at MedImmune Vaccines in January 1999 to December 2004
Associate Director Engineering at Chiron Corporation in January 1992 to January 1999
Associate Director Engineering at Chiron Corporation in January 1992 to January 1999
Plant Engineer at Bayer in January 1989 to January 1992
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University of Arkansas, Bachelor's degree, November 1986
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FDA
Manufacturing
Validation
Process Simulation
Engineering
Biotechnology
Biopharmaceuticals
GMP
Technology Transfer
Quality System
Continuous Improvement
Sop
Change Control
CAPA
21 CFR Part 11
SOP
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
U.S. Title 21 CFR Part 11 Regulation
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What is Keith Life email address?
Email Keith Life at [email protected]. This email is the most updated Keith Life's email found in 2026.
What is Keith Life phone number?
Keith Life phone number is +17073876210.
How to contact Keith Life?
To contact Keith Life send an email to [email protected]. If you want to call Keith Life try calling on +17073876210. (updated on May 03, 2025)
What company does Keith Life work for?
Keith Life works for BioMarin
What is Keith Life's role at BioMarin?
Keith Life is Site Head Manufacturing
What industry does Keith Life work in?
Keith Life works in the Biotechnology industry.
Keith Life Email Addresses
Keith Life Phone Numbers
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