Gustavo Aguilar
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Senior Quality Assurance Specialist at Genentech
United States
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Résumé
Jobs
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Senior Quality Assurance SpecialistGenentechJun 2023 - Current (3 years 5 months)- Quality Assurance Specialist IIIGenentechJul 2020 - Jun 2023 (3 years)
- AProduction Engineer IIAdaptive Phage TherapeuticsApr 2020 - Jul 2020 (4 months)Production Engineer II
• Subject Matter Expert (SME) and lead validation engineer on robotic isolator, aseptic filling, and cleanroom operations.
• Manage Fill/Finish phase of manufacturing operations and auxiliary components.
• Technical adviser for aseptic processing and current Good Manufacturing Practices (cGMPs) for overall product manufacturing and processing.
• Technical trainer for aseptic technique and documentation practices.
QA/QC Specialist and Writer
• Create and edit batch records, standard operating procedures (SOPs), forms, and official documentation for adherence to developed protocols, Quality Management System (QMS), and cGMPs.
• Review routinely generated batch records, forms, and - AProduction Engineer IAdaptive Phage TherapeuticsMar 2018 - Apr 2020 (2 years 2 months)Production Engineer I
• Subject Matter Expert (SME) and lead validation engineer on robotic isolator, aseptic filling, and cleanroom operations.
• Manage Fill/Finish phase of manufacturing operations and auxiliary components.
• Technical adviser for aseptic processing and current Good Manufacturing Practices (cGMPs) for overall product manufacturing and processing.
• Technical trainer for aseptic technique and documentation practices.
QA/QC Specialist and Writer
• Create and edit batch records, standard operating procedures (SOPs), forms, and official documentation for adherence to developed protocols, Quality Management System (QMS), and cGMPs.
• Review routinely generated batch records, forms, and - Core Technician ILonzaAug 2016 - Mar 2018 (1 year 8 months)cGMP production of cellular products for commercial and clinical stage applications
Documentation, Understanding, and Compliance in the execution of cGMPs in a manufacturing environment
Aid in technology transfers from product development to cGMP areas - LUndergraduate Researcher - ChemistryLSU Superfund Research GroupMay 2015 - Aug 2016 (1 year 4 months)Reactor Building and Design
Chemical Conversions and Optimization
Chemical Analysis - LUndergraduate Researcher - Biological EngineeringLSU Superfund Research GroupAug 2013 - Jun 2016 (2 years 11 months)Reactor maintenance and improvement
Chemical Analysis
Experimental design
Education
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- Bachelor's degree, Biological/Biosystems EngineeringLouisiana State UniversityJan 2010 - Dec 2016 (7 years)
Projects (professional or personal)
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Awards
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- SUndergraduate Research GrantSigma Xi The Scientific Research SocietyCompeted for grant as a non-member
Wrote detailed projections, outline, support, and budget - L2nd Place, Undergraduate Research ConferenceLSU Office of Strategic InitiativesDivision: Engineering and Technology
Category: Oral Presentations
Publications
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- EPyrolysis of Lignin in Gas-Phase Isothermal and cw-CO2 Laser Powered Non-Isothermal ReactorsEnergy and Fuels
- Effects of biomass particle size on yield and composition of pyrolysis bio-oil derived from Chinese tallow tree (TriadicAIMS PRESS
- Ex situ thermo-catalytic upgrading of biomass pyrolysis vapors using a traveling wave microwave reactorApplied Energy