Alberto Gonzalez

Alberto Gonzalez Email and Phone Number

Quality Executive in the Pharma and Biotech space @ Beacon Life Sciences Inc.
Alberto Gonzalez's Location
Santa Monica, California, United States, United States
Alberto Gonzalez's Contact Details
About Alberto Gonzalez

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."

Alberto Gonzalez's Current Company Details
Beacon Life Sciences Inc.

Beacon Life Sciences Inc.

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Quality Executive in the Pharma and Biotech space
Alberto Gonzalez Work Experience Details
  • Beacon Life Sciences Inc.
    Founder And Principal Consultant
    Beacon Life Sciences Inc. May 2019 - Present
    San Francisco, California, Us
  • Kite Pharma
    Director Quality Engineering, Corporate Quality
    Kite Pharma Nov 2021 - Feb 2024
    Santa Monica, California, Us
  • Azzur Group
    Director
    Azzur Group Apr 2020 - Oct 2021
    Hatboro, Pennsylvania, Us
  • Ultragenyx Pharmaceutical Inc.
    Cmc Qa Special Projects Lead
    Ultragenyx Pharmaceutical Inc. Oct 2018 - Apr 2019
    Novato, California, Us
  • Ultragenyx Pharmaceutical Inc.
    Patient Engagement Manager
    Ultragenyx Pharmaceutical Inc. Feb 2018 - Oct 2018
    Novato, California, Us
  • Ultragenyx Pharmaceutical Inc.
    Associate Director Chief Of Staff Commercial Leadership Team
    Ultragenyx Pharmaceutical Inc. Sep 2017 - Feb 2018
    Novato, California, Us
  • Ultragenyx Pharmaceutical Inc.
    Senior Manager Quality Validation Engineering
    Ultragenyx Pharmaceutical Inc. Apr 2016 - Sep 2017
    Novato, California, Us
  • Genentech
    Technical Manager, Quality Engineering Validation, Vacaville Operations
    Genentech Mar 2014 - Apr 2016
    South San Francisco, California, Us
  • Novartis Vaccines And Diagnostics
    Validation Manager
    Novartis Vaccines And Diagnostics Jun 2012 - Mar 2014
    Basel, Baselstadt, Ch
    Highlights: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.
  • Genentech
    Sr. Validation Engineer
    Genentech Feb 2009 - Jun 2012
    South San Francisco, California, Us
    Responsible 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.
  • Excelsus Scientific Engineering
    Validation Consultant
    Excelsus Scientific Engineering Jan 2006 - Jan 2009
    Performed 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.
  • Center For Astrophysics And Space Astronomy, University Of Colorado At Boulder
    Research Assistant
    Center For Astrophysics And Space Astronomy, University Of Colorado At Boulder Sep 2002 - May 2003

Alberto Gonzalez Skills

Validation Gmp Cleaning Validation Biotechnology Capa Change Control Fda Computer System Validation 21 Cfr Part 11 Quality System Biopharmaceuticals Gxp Gamp Sop Pharmaceutical Industry Corrective And Preventive Action Start Ups Technology Transfer U.s. Food And Drug Administration Cgmp Design Of Experiments Risk Management Standard Operating Procedure Quality Systems Product Lifecycle Management Commercial Planning Customer Engagement Life Sciences Cross Functional Team Leadership Manufacturing Quality Assurance Management Verification And Validation Pharmaceutics Cell Culture Project Management Customer Relationship Management Customer Retention

Alberto Gonzalez Education Details

  • Babson F.W. Olin Graduate School Of Business
    Babson F.W. Olin Graduate School Of Business
    Entrepreneurship
  • University Of Colorado Boulder
    University Of Colorado Boulder
    Mechanical Engineering
  • Universidad Austral, Buenos Aires
    Universidad Austral, Buenos Aires
    Ingeniería Informática
  • Instituto Tecnológico De Buenos Aires
    Instituto Tecnológico De Buenos Aires
    Computer Engineering
  • Belgrano Day School
    Belgrano Day School
    High 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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