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Associate Director, Quality Sterility Assurance And Aseptic Controls
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- The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing.
- The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs.
- Provide quality oversight of the environmental and utilities monitoring programs for Vertex CGT facilities, technical input into environmental/facility monitoring program excursions and identified trends, and contamination events to determine impact to batch disposition.
- Work closely with business colleagues to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.
- Project scopes may include large projects to design, construction, fit out, qualification and startup of new facilities for the manufacturing, testing, and or storage of cell and gene therapy products.
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