Michael Barlow

Michael Barlow Email and Phone Number

Biologics and Cell Therapy Operations Start-Up, Scale-Up and Optimization @ GMPKit
Michael Barlow's Location
Snohomish, Washington, United States, United States
Michael Barlow's Contact Details
About Michael Barlow

Results driven leader in the multi-product, commercial cGMP production environment. Experience with start up and scale up of large molecule biologics and CAR T cell therapy. Passionate about developing leaders and implementing operations management concepts to streamline and scale operations. Demonstrated strengths include well-developed problem solving skills, leadership development, solid understanding of quality systems, lean manufacturing/ DMAIC tools, and productivity improvement.

Michael Barlow's Current Company Details
GMPKit

Gmpkit

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Biologics and Cell Therapy Operations Start-Up, Scale-Up and Optimization
Michael Barlow Work Experience Details
  • Gmpkit
    Founder Gmpkit, Llc
    Gmpkit Apr 2023 - Present
    Started GMPKit, a turn-key GMP Operations Management framework. Equip your team with the tools and training that they need to start and scale the right way so that your operations are safe, compliant and on schedule.
  • Agc Biologics
    Vice President, Manufacturing
    Agc Biologics Mar 2021 - Mar 2023
    Bothell, Wa, Us
    Hired to support Seattle site LEAN transformation and stabilize manufacturing operations. Increased batch success rate year over year from 75% in 2021 to 93% in 2022 and to 100% in Q1 of 2023. Partnered and collaborated with site leaders to develop and deploy strategy that increased retention and improved batch disposition throughput.
  • Bristol Myers Squibb
    Associate Director, Cell Therapy Manufacturing Operations
    Bristol Myers Squibb Jun 2017 - Mar 2021
    Lawrence Township, Nj, Us
    Hired by JUNO Therapeutics (subsequently acquired by Celgene) to support the start up and scale up of cell therapy manufacturing from clinical operations to high throughput commercial GMP operations. Responsible for building and leading an operations team of appx. 150 FTE and executing cell therapy unit operations including selection (separation), activation, transduction and harvest operations. Actively prepared the team and directly participated in PPQ through FDA PLI Inspection.Associate Director, Manufacturing Operations: October 2019 – Mar 2021Head of Manufacturing (Interim): June 2019-Feb 2020Interim Head of Supply Chain (Interim): August 2019 – October 2019Manager/Sr. Manager, Manufacturing Operations: June 2017 – October 2019
  • Agc Biologics
    Large Scale Antibody Process Transfer / Upstream Poduction Manager
    Agc Biologics Mar 2015 - Jun 2017
    Bothell, Wa, Us
    Hired as a process transfer manager supporting the startup of a new facility in Berkeley CA. Upon successful launch, reassigned to finish the startup of a high capacity single use production line. In March of 2016 was assigned responsibility of upstream production operations at the Seattle WA site.Technology Transfer Manager, Bioprocess Sciences (2015-2016)Upstream Manufacturing Operations Manager (2016-2017)
  • Novartis
    Production Manager/Team Lead
    Novartis Jan 2011 - Apr 2015
    Basel, Baselstadt, Ch
    Hired to help large scale commercial product launch. Serving on the sites production leadership team to deploy the Production Unit's strategic plan for multiproduct manufacturing with a specific focus on improved quality performance, safety, and batch release cycle times. Production operations included Upstream (Yeast and E. Coli Cell Culture) and Downstream (Purification) production operations.
  • Genentech Inc
    Quality Assurance Sr. Manager
    Genentech Inc Jun 2007 - Nov 2009
    South San Francisco, California, Us
    Responsible for building, developing and leading a team that will deploy QA systems (batch review and deviation assessment) in Genentech's new CCP2 production facility.
  • Genentech
    Quality Assurance Technical Manager
    Genentech Feb 2005 - Feb 2007
    South San Francisco, California, Us
    Responsible for providing quality assurance user requirements as a team member on Genentech's CCP2 client team.
  • Genenetech, Inc
    Quality Assurance Supervisor
    Genenetech, Inc Feb 2000 - Mar 2005
    Responsible for Leading a Quality Assurance team at the Genentech's Vacaville CA production facility that provided quality oversight of manufacturing operations:Batch Record ReviewDeviation ManagementEngineering Change Control ApprovalDocument Change Control ApprovalManufacturing Support (Compliance guidance)
  • Genentech
    Quality Assurance Associate
    Genentech Sep 1998 - Jan 2000
    South San Francisco, California, Us
    Member of quality start up team that built paper and electronic batch record review and product release systems in preparation for Herceptin, Rituxan, and Xolair product launch and PAI activities.
  • Genentech
    Manufacturing Production Technician
    Genentech Jul 1996 - Oct 1999
    South San Francisco, California, Us
    Responsible for cGMP Upstream activities in clinical and commercial manufacturing. Start up team member for Genentech's CCP1 facility including the start-up/valdation of fully automated CIP systems and bioreactors.
  • Washington Army National Guard
    Spc-4
    Washington Army National Guard 1990 - 1995
    Arlington, Virginia, Us
    1st Battalion, 161st Infantry Division, Spokane WA.

Michael Barlow Skills

Pharmaceutical Industry Quality System Biotechnology Capa Quality Assurance 21 Cfr Part 11 Change Control Cross Functional Team Leadership Life Sciences Leadership Lean Manufacturing Manufacturing Gmp Software Documentation Quality Control Business Development Biopharmaceuticals Validation Sop Fda Fmea Computer System Validation Gxp Standard Operating Procedure Glp Entrepreneurship Technology Transfer Ich Guidelines Fda Gmp Operations Management Process Improvement U.s. Food And Drug Administration Lims V&v Strategic Planning 5s Aseptic Processing Medical Devices

Michael Barlow Education Details

  • University Of Idaho
    University Of Idaho
    Microbiology

Frequently Asked Questions about Michael Barlow

What company does Michael Barlow work for?

Michael Barlow works for Gmpkit

What is Michael Barlow's role at the current company?

Michael Barlow's current role is Biologics and Cell Therapy Operations Start-Up, Scale-Up and Optimization.

What is Michael Barlow's email address?

Michael Barlow's email address is mb****@****bio.com

What schools did Michael Barlow attend?

Michael Barlow attended University Of Idaho.

What are some of Michael Barlow's interests?

Michael Barlow has interest in Collecting Antiques, Exercise, Home Improvement, Reading, Gourmet Cooking, Sports, The Arts, Home Decoration, Photograph, Children.

What skills is Michael Barlow known for?

Michael Barlow has skills like Pharmaceutical Industry, Quality System, Biotechnology, Capa, Quality Assurance, 21 Cfr Part 11, Change Control, Cross Functional Team Leadership, Life Sciences, Leadership, Lean Manufacturing, Manufacturing.

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