2013 -2014 Regulatory Affairs Associate II - CMC @
2012 -2013 Quality Assurance Specialist II @
2012 -2012 QTS Technical Writer and Reviewer (Consultant) @
2011 -2012 Quality Assurance Specialist @
2010 -2011 Quality Control Associate I @
2008 -2010 Manufacturing Associate II @
2006 -2008 Bioprocessing Technician @
Gary Low Education
University of Southern California
MS (Regulatory Science)
2010-2012
B.S (Biochemistry & Molecular Biology)
B.A (Economics)
Gary Low Skills
Quality Assurance
Regulatory Affairs
Quality Systems
Root Cause Analysis
Cleaning Validation
NC/CAPA
Maximo
cGMP
SOP
Document Management
SAP
Matlab
Validation
Manufacturing
QC
Microsoft Office
PowerPoint
Word
Excel
21 CFR Part 11
Biopharmaceuticals
Pharmaceutical Industry
LIMS
Biotechnology
V
Change Control
Trackwise
Technology Transfer
Aseptic Processing
Aseptic Technique
cGMP manufacturing
cGMP practices
Purification
GMP
Microsoft Word
Quality Control
IND
Regulatory Submissions
Regulatory Requirements
CMC
NDA
Cell Culture
Pharmaceutics
Oncology
Protein Purification
Fermentation
Monoclonal Antibodies
CAPA
FDA
Dispositions
Multi Tasking
Analysis
UV
Commissioning
Product Safety
Quality Auditing
Meters
SAP XI
Debugging
Quality Results
Yellow Belt
Raps
Efficient
Outlook
Leadership
Regulations
Approvals
Drug Product
Dat
Six Sigma
Hemophilia
Collaborative
Stability Testing
Bioprocessing
Column Chromatography
Stability
Economics
Communication
Non Conforming
Gel Electrophoresis
Filtration
Shimadzu
International
Chromatography
Mcs
Conductivity
FIX Protocol
Oversight
FPLC
ASQ
Special Projects
Clinical Research
Mbr
Concepts
Compliance
Regulatory
Structure
Assessment
Bcs
Interfaces
Analytical Techniques
Dsi
Validating
CIP
Propose
Biochemistry
Delta V
21 CFR
Licensure
American
Timelines
Exception Management
Autoclave
Medicine
Clinical Manufacturing
Compact
Shutdown
Tff
JD Edwards
Spectrophotometry
Research
Bulk
Aseptic
Testing
Management
Insurance
Regulatory Science
Substance
SIP
Downstream Oil and Gas
Start Ups
Batch Processing
UV/Vis
Molecular Biology
Hoods
Community
Submissions
Training Manuals
Batch Records
Rewriting
Microsoft Excel
Operations
Lean Manufacturing
Trains and Add Rails
Reports
Washers
Sterilization
Human Resources
Formulate
Corrective Actions
Quick Turn Around
Qualification
Trails
Control Systems Design
Methodology
System
Gary Low Summary
Gary Low, based in San Mateo, CA, US, is currently a Director - Regulatory Affairs CMC at Ultragenyx. Gary Low brings experience from previous roles at Ultragenyx and Gilead Sciences. Gary Low holds a 2010 - 2012 MS in Regulatory Science @ University of Southern California. With a robust skill set that includes Quality Assurance, Regulatory Affairs, Quality Systems, Root Cause Analysis, Cleaning Validation and more. Gary Low has 1 emails and 4 mobile phone numbers on RocketReach.
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