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SME Lean Bronze Certification (trained by GBMP, Inc.)Highly technical management professional with nearly 20 years experience in clinical/commercial biologic's manufacturing, supply chain operations specializing in materials management, clinical label-packaging, distribution, and validation. Other areas of knowledge include areas of supply chain quality assurance, and quality control.
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Director Contract ManufacturingUltragenyxBoston, Ma, Us
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Director Contract ManufacturingUltragenyx Sep 2022 - PresentNovato, California, Us -
Associate Director Contract ManufacturingUltragenyx Sep 2020 - PresentNovato, California, Us
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Sr. Manager Contract Manufacturing Gene TherapyUltragenyx Feb 2019 - PresentNovato, California, Us
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Manufacturing SupervisorBrammer Bio Nov 2017 - Feb 2019Cambridge, Massachusetts, Us -
Manufacturing ManagerLonza Feb 2017 - Nov 2017Basel, Ch -
Senior Supervisor Materials ManagementBiogen Idec Feb 2013 - Dec 2016Cambridge, Ma, UsSupervisor of Clinical label-pack finished goods, Clinical distribution, cell bank storage, and raw materials.- Managed up to 15 direct reports in all GMP areas such as raw materials, cell bank storage, clinical distribution , and clinical label-pack.- Responsible for daily activities in all GMP areas.- Manager review all deviations, corrective action plans, and planned exceptions.- Review and approve specifications, and validation protocols.- Responsible for documentation revisions and biannual reviews.- Participated in regulatory inspections for FDA, EMEA, and Health Canada- -
Supervisor Materials MangementBiogen Idec May 2009 - Jan 2013Cambridge, Ma, Us- Responsible for Development of operators and ensuring that each operator has detailed performance and development plans.- Responsible for the daily label-packaging production schedule and communication with the clinical drug supply planners.- Maintain label-pack inventory levels. Order production material/components to support finished good packaging. good -Implement and improve operations by eliminating waste and utilizing one piece continuous flow operation.- Revise and create new procedures for improved efficiencies and quality of finished good product.- Authored manufacturing reports for repackaging jobs and training kits for clinician use for demonstration purposes.
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Manufacturing Lead Operator (Upstream Cell Culture)Biogen Idec Feb 2005 - Apr 2009Cambridge, Ma, Us- Maintain up to date schedule of manufacturing activities.- Communicate cross functionally in other areas such as maintenance, engineering, validation, and planning depts.- Troubleshoot technical issues as they arise and make process related decisions that will aide in maintaining process schedules.- Mentor train lesser experienced operators.- Responsible for reporting personnel issues directly to the supervisor.
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Manufacturing Associate Ii - IvBiogen Idec Sep 1997 - Jan 2005Cambridge, Ma, Us-Vast technical knowledge of performing all biologics process manufacturing. Expertise in all bioreactor and harvest operations- Inoculation specialist trained in aseptic technique and performing all operations pertaining to scale up.- Create, initiate, and execute validation protocols. Participated in facility startup, commissioning, and factory assembly testing, and cold room validation.- Performed all operations in Dispensary including weighing/ mixing buffers and media additions.- Performed all production support activities including aseptic fill, and purification operations.
Brian Hoadley Skills
Brian Hoadley Education Details
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Southern New Hampshire UniversityBusiness
Frequently Asked Questions about Brian Hoadley
What company does Brian Hoadley work for?
Brian Hoadley works for Ultragenyx
What is Brian Hoadley's role at the current company?
Brian Hoadley's current role is Director Contract Manufacturing.
What is Brian Hoadley's email address?
Brian Hoadley's email address is ho****@****dec.com
What schools did Brian Hoadley attend?
Brian Hoadley attended Southern New Hampshire University.
What skills is Brian Hoadley known for?
Brian Hoadley has skills like Management, Microsoft Office, Biotechnology, Pharmaceutical Industry, Customer Service, Strategic Planning, Research, Leadership, Cross Functional Team Leadership, U.s. Food And Drug Administration, Quality System, Microsoft Excel.
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