Founder Gmpkit, Llc
CurrentStarted 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.
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Michael Barlow is listed as Biologics and Cell Therapy Operations Start-Up, Scale-Up and Optimization at GMPKit, based in Snohomish, Washington, United States. AeroLeads shows a work email signal at agcbio.com and a matched LinkedIn profile for Michael Barlow.
Michael Barlow previously worked as Founder GMPKit, LLC at Gmpkit and Vice President, Manufacturing at Agc Biologics. Michael Barlow holds Bs, Microbiology from University Of Idaho.
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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.
Listed skills include Pharmaceutical Industry, Quality System, Biotechnology, Capa, and 34 others.
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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.
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.
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).
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.
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.
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.
South San Francisco, California, US
Responsible for providing quality assurance user requirements as a team member on Genentech's CCP2 client team.
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)
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.
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.
Arlington, Virginia, US
1st Battalion, 161st Infantry Division, Spokane WA.
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Michael Barlow works for GMPKit.
Michael Barlow is listed as Biologics and Cell Therapy Operations Start-Up, Scale-Up and Optimization at GMPKit.
AeroLeads has found 1 work email signal at @agcbio.com for Michael Barlow at GMPKit.
Michael Barlow is based in Snohomish, Washington, United States while working with GMPKit.
Michael Barlow has worked for Gmpkit, Agc Biologics, Bristol Myers Squibb, Novartis, and Genentech Inc.
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Michael Barlow holds Bs, Microbiology from University Of Idaho.
Michael Barlow is listed with skills including Pharmaceutical Industry, Quality System, Biotechnology, Capa, Quality Assurance, 21 Cfr Part 11, Change Control, and Cross Functional Team Leadership.
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