David Huebner

Nebraska . Kearney - United States

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电子邮件 ema***@***.com

David Huebner 当前工作场所

Waypoint Consulting, LLC

Waypoint Consulting is an independent consultancy with a focus in the Life Sciences industry. WC offers extensive experience in the management of operations, manufacturing and quality of various small molecules, biologics, biomaterials, and medical devices from Clinical, Commercialization, through Growth, and Maturity. WC can provide support from strategies to varying levels of depth to help you reach your goals. WC can provide overall strategic support for development, commercialization, manufacturing, and supply. Specific elements to include the development, implementation, and/or improvement in the following: - Production and Supply Chain planning from raw materials, intermediates, final products, to finished goods. - Long range and capacity planning. - Contract manufacturing assessment, agreements, and performance management. - Process characterization, development, and validation within QbD and Design Control Systems. - Manufacturing and Supply for Clinical Trials, Commercial Launch, Scale up and Growth, through to maturity. - Design, use, and control of classified manufacturing environments. - Aseptic manufacturing: Grade A Suites, RABs, and Isolators - Product terminal sterilization: Gamma, e-Beam, EtO. - Continuous improvement, lean manufacturing, and efficiencies. - Manufacturing and Quality Management Systems: daily management to e-systems. - Risk Management. - Quality Systems, Quality Assurance and Compliance. - QbD and Design Control Systems

David Huebner 简介

公司 Waypoint Consulting, LLC
职位 Founder, Principal
地点 United States
LinkedIn http://www.linkedin.com/in/david-huebner-7745994b
部门 c_suite
头衔

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David Huebner 的电子邮件地址是 ema***@***.com

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David Huebner 在 pharmaceuticals 工作。

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David Huebner 的个人领英是:http://www.linkedin.com/in/david-huebner-7745994b

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David Huebner 的办公地点:275 Beacon Street, No. 1B, Boston, MA 02116, US

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