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Tech Transfer Scientist/Engineer

Company: Global Channel Management, Inc.
Location: Saint Peters
Posted on: September 6, 2018

Job Description:

This position is responsible for taking an active role in the technical transfer of processes into the clinical manufacturing facility and/or transfer of processes out to commercial manufacturing or a CMO. Some of the detailed responsibilities will include: - Lead meetings to facilitate the Tech Transfer process. - Identify, communicate, track, and hold team members accountable for project deliverables. - Evaluate lab-scale processes and define the scaled up process for the clinical production facility. - Interface with development scientists and propose options to resolve process fitting issues. - Capture and convey process details by preparing detailed Process Flow Diagrams - Provide raw material forecasts for clinical campaigns. - Write master batch records and solution records for clinical production. - Monitor the progression of the clinical campaigns and provide data summaries to stakeholders - Write campaign summaries and provide information for regulatory filings - Participate in and/or initiate continuous improvement projects. - Provide support for engineering studies of equipment or processes. - Maintain safety and cGMP training. Qualifications Background in a biological or engineering discipline (Biotechnology, Biochemistry, Biochemical Engineering, or equivalent). Experience with project management tools and methodologies is desirable.

Keywords: Global Channel Management, Inc., Saint Peters , Tech Transfer Scientist/Engineer, Engineering , Saint Peters, Missouri

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