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Long le Location
San Francisco, CA, US
Long le Work
2022 -now Regulatory Affairs CMC Associate Director @
2021 -2022 Regulatory Affairs CMC Associate Director @
2018 -2021 Regulatory Affairs CMC Sr. Manager @
2014 -2018 Quality Assurance Manager and Sr. Manager @
2010 -2014 Quality Control Supervisor and Sr. Supervisor @
2009 -2010 Quality Control Associate 1 @
2004 -2009 Quality Control Analyst 1 and Analyst 2 and Sr. Analyst @
2002 -2003 Manufacturing Technician @ Biomass Systems
2001 -2002 Process Development Cell Culture Analyst @
Long le Education
University of Virginia
Bachelor of Arts (BA) (Biology, General)
Long le Skills
Leadership
Moda
Good Laboratory Practice Glp
Quality Systems Design
Root Cause Analysis
GMP
GxP
Biotechnology
Change Control
Life Sciences
Validation
Trackwise
Quality Assurance
Corrective And Preventive Action Capa
Quality System
Microsoft Office
Discrepancy Resolution
Aseptic Technique
Laboratory Information Management System Lims
Quality Auditing
Laboratory Skills
Manufacturing
U.S. Food And Drug Administration Fda
FDA GMP
Environmental Compliance
Microbiology
Management
Standard Operating Procedure Sop
Quality Control
Pharmaceutical Industry
Compliance Management
CAPA
FDA
Environmental Monitoring
Sop
21 CFR Part 11
Biopharmaceuticals
Internal Audit
u.s. Food and Drug Administration
Standard Operating Procedure
Corrective and Preventive Action
Good Laboratory Practice
Laboratory Information Management System
Long le Summary
Long le, based in San Francisco, CA, US, is currently a Regulatory Affairs CMC Associate Director at Gilead Sciences. Long le brings experience from previous roles at Fate Therapeutics Inc and BioMarin Pharmaceutical Inc.. Long le holds a Bachelor of Arts (BA) in Biology, General @ University of Virginia. With a robust skill set that includes Leadership, Moda, Good Laboratory Practice Glp, Quality Systems Design, Root Cause Analysis and more. Long le has 4 emails and 5 mobile phone numbers on RocketReach.
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