Biomanufacturing Associate (Production Associate I) - Open Pool

  • Colorado State University
  • Colorado, USA
  • Dec 15, 2020
Full time  

Job Description

The Biomanufacturing Associate (Production Associate I) will be responsible for production activities of a cGMP manufacturing campaign under FDA regulations. This job responsibilities require gaining escalating levels of experience in executing complicated batch production records for the creation and/or processing of production materials. Employees will work within an FDA recognized Quality System (or similar) using Quality Assurance approved batch cards, SOPs, protocols and/or the like. Continuous directed and self-directed training in the US Code of Federal Regulation fields of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and/or Quality Assurance/Control will be expected of each employee. Employees will physically perform complex laboratory techniques in rooms that require specialized manufacturing and biocontainment protective gowning and equipment. Entering a Biosafety level (BSL) 2 and/or 3 laboratory is highly likely. Moreover, employees will think critically through instructions and make professional judgments with regard to compliance, quality and continuous improvement paradigms. Employees will investigate and report on incidents and provide intelligent corrective proposals. In addition to GMP work, Process Development, Pre-clinical Production and Non-Clinical production/research support may be assigned with the expectations that the employee make use of skills similar to that described above.

Application Details

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Applicants with dual-career considerations can find university jobs such as professor jobs, dean jobs, chair / department head jobs, and other faculty jobs and employment opportunities at Colorado State University and at other institutions of higher education in the region on