Michael Barlow Email and Phone Number
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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.
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Founder Gmpkit, LlcGmpkit Apr 2023 - PresentStarted 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. -
Vice President, ManufacturingAgc Biologics Mar 2021 - Mar 2023Bothell, Wa, UsHired 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. -
Associate Director, Cell Therapy Manufacturing OperationsBristol Myers Squibb Jun 2017 - Mar 2021Lawrence Township, Nj, UsHired 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 -
Large Scale Antibody Process Transfer / Upstream Poduction ManagerAgc Biologics Mar 2015 - Jun 2017Bothell, Wa, UsHired 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) -
Production Manager/Team LeadNovartis Jan 2011 - Apr 2015Basel, Baselstadt, ChHired 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. -
Quality Assurance Sr. ManagerGenentech Inc Jun 2007 - Nov 2009South San Francisco, California, UsResponsible for building, developing and leading a team that will deploy QA systems (batch review and deviation assessment) in Genentech's new CCP2 production facility. -
Quality Assurance Technical ManagerGenentech Feb 2005 - Feb 2007South San Francisco, California, UsResponsible for providing quality assurance user requirements as a team member on Genentech's CCP2 client team. -
Quality Assurance SupervisorGenenetech, Inc Feb 2000 - Mar 2005Responsible 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)
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Quality Assurance AssociateGenentech Sep 1998 - Jan 2000South San Francisco, California, UsMember 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. -
Manufacturing Production TechnicianGenentech Jul 1996 - Oct 1999South San Francisco, California, UsResponsible 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. -
Spc-4Washington Army National Guard 1990 - 1995Arlington, Virginia, Us1st Battalion, 161st Infantry Division, Spokane WA.
Michael Barlow Skills
Michael Barlow Education Details
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University Of IdahoMicrobiology
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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