Alberto Gonzalez Email and Phone Number
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Alberto Gonzalez is a Quality Executive in the Pharma and Biotech space at Beacon Life Sciences Inc.. He possess expertise in validation, gmp, cleaning validation, biotechnology, capa and 33 more skills. Colleagues describe him as "While at Novartis, Alberto served as interim manager of the Cleaning Validation group during a critical transitional time in the department. Among his noteworthy contributions, Alberto led the effort to establish a streamlined cleaning process development program, effectively managed and helped reduce the number of legacy DRs/CAPAs and demonstrated his leadership through informed and decisive decision making that helped the department overcome stalled projects and quality initiatives.", "As a Validation Engineer Alberto demonstrated outstanding technical knowledge and strong leadership skills during his time at the Emeryville Site. As a result he was promoted to manage the cleaning and sterilisation validation department. He effectively led a diverse team of engineers, undertaking complex development and process improvement projects, whilst maintaining base business targets. I found Alberto to be an excellent manager, who remained calm, personable and approachable even under extreme pressure. I would have no hesitation in recommending him for future technical or leadership roles.", and "I had the good fortune of working with Alberto when he was Cleaning Validation Manager at Novartis-Emeryville. He managed the Cleaning Validation team and was involved in a large number of projects like Stage Development, requalification studies, Gaps, CAPA and Deviation. My experiences working with Alberto have been positive, open, and informative. He made sure that the team had everything they need to be successful and there was quick turnaround of deliverables. He was able to come up with creative strategies for difficult problems when dealing with Validation projects. He has a very strong technical background, is an excellent team player, as well as being a creative problem solver. He was always willing to step forward and take ownership of key activities. I would recommend him to any company looking for a dedicated Validation Specialist and would be more than happy to speak as a reference for him."
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Founder And Principal ConsultantBeacon Life Sciences Inc. May 2019 - PresentSan Francisco, California, Us -
Director Quality Engineering, Corporate QualityKite Pharma Nov 2021 - Feb 2024Santa Monica, California, Us -
DirectorAzzur Group Apr 2020 - Oct 2021Hatboro, Pennsylvania, Us -
Cmc Qa Special Projects LeadUltragenyx Pharmaceutical Inc. Oct 2018 - Apr 2019Novato, California, Us -
Patient Engagement ManagerUltragenyx Pharmaceutical Inc. Feb 2018 - Oct 2018Novato, California, Us -
Associate Director Chief Of Staff Commercial Leadership TeamUltragenyx Pharmaceutical Inc. Sep 2017 - Feb 2018Novato, California, Us -
Senior Manager Quality Validation EngineeringUltragenyx Pharmaceutical Inc. Apr 2016 - Sep 2017Novato, California, Us -
Technical Manager, Quality Engineering Validation, Vacaville OperationsGenentech Mar 2014 - Apr 2016South San Francisco, California, Us -
Validation ManagerNovartis Vaccines And Diagnostics Jun 2012 - Mar 2014Basel, Baselstadt, ChHighlights:Team Assembly - Hired a strong team with a mixed set of skills: project management experience, strong engineering and biotech validation background and proven situational leadership.Gap Assessment - Designed and executed a cleaning validation gap assessment to understand the current state of compliance of the various GMP cleaning processes. Developed a risk assessment tool to rank each gap identified, based on impact to product quality and compliance with Quality System. Three Pronged Approach Solution - 1) evaluated the robustness of the cleaning validation of process equipment; 2) developed a risk scoring tool to rank each gap identified; 3) developed gap remediation schedule based on risk prioritization score.Process Implementation - Implemented a method for designing cleaning processes, and define the approach to cleaning process design. The result was a streamlined approach to provide assurance that a newly defined cleaning process is sound from a process perspective as well as a cleaning validation perspective and can be validated.Incorporated the use of Project Plans for big projects to understand deliverables, project phases, gating requirements (such as IFA, IFD and IFC), process mapping, among other features. -
Sr. Validation EngineerGenentech Feb 2009 - Jun 2012South San Francisco, California, UsResponsible for supporting Operations in maintaining the right-to-operate of the SSF facility in compliance with FDA and EMA regulations. Served as a Project Manager on cross-functional and multi-site teams for capital projects and technology transfers as well as audit and inspections.Procurement - Negotiated contractor bids from various consulting companies for services while adhering to annual budget constraints.Ownership - Responsible for the Cell Banking, Seed Train and Cell Culture areas Equipment Qualification, Cleaning Validation and Risk Management programs.Operations - Manufacturing and Process Support for marketed products tech transfer and capital projects.Process Management - Equipment Dirty Hold Time; coordinated execution with Engineering, Ops and Quality units. -
Validation ConsultantExcelsus Scientific Engineering Jan 2006 - Jan 2009Performed validation consulting services for Genentech and Catalent CMO (Woodstock, IL). On-site qualification testing of pharmaceutical equipment in SSF and HTO.Business Development -Prospecting, negotiating and closing new contracts, customer surveying, budget and invoice management.Project Management - Supervised and coordinated big scope validation projects for Genentech’s Lab Services groupValidation hands on experience -Ranging from SIP stations and Fermentors, to Autoclaves and Glassware Washers, to Lyophilizers and SIP of filling lines, Stopper Processor validation. NPI cleaning validation. Validation protocol generation and execution.
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Research AssistantCenter For Astrophysics And Space Astronomy, University Of Colorado At Boulder Sep 2002 - May 2003
Alberto Gonzalez Skills
Alberto Gonzalez Education Details
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Babson F.W. Olin Graduate School Of BusinessEntrepreneurship -
University Of Colorado BoulderMechanical Engineering -
Universidad Austral, Buenos AiresIngeniería Informática -
Instituto Tecnológico De Buenos AiresComputer Engineering -
Belgrano Day SchoolHigh School
Frequently Asked Questions about Alberto Gonzalez
What company does Alberto Gonzalez work for?
Alberto Gonzalez works for Beacon Life Sciences Inc.
What is Alberto Gonzalez's role at the current company?
Alberto Gonzalez's current role is Quality Executive in the Pharma and Biotech space.
What is Alberto Gonzalez's email address?
Alberto Gonzalez's email address is go****@****ene.com
What is Alberto Gonzalez's direct phone number?
Alberto Gonzalez's direct phone number is +141548*****
What schools did Alberto Gonzalez attend?
Alberto Gonzalez attended Babson F.w. Olin Graduate School Of Business, University Of Colorado Boulder, Universidad Austral, Buenos Aires, Instituto Tecnológico De Buenos Aires, Belgrano Day School.
What are some of Alberto Gonzalez's interests?
Alberto Gonzalez has interest in Economic Empowerment, Politics, Education, Science And Technology, Arts And Culture, Health.
What skills is Alberto Gonzalez known for?
Alberto Gonzalez has skills like Validation, Gmp, Cleaning Validation, Biotechnology, Capa, Change Control, Fda, Computer System Validation, 21 Cfr Part 11, Quality System, Biopharmaceuticals, Gxp.
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