Biotech Process Engineer

Details: Biotech Process Engineer Manufacturing & Operations Salary – up to $110k per year Location – Greater Houston Area, TX Job Summary The primary focus of the Process Engineer will be to develop and drive execution of global technology transfers and provide technical support for cell therapy manufacturing processes and analytical methods. This person will lead all aspects of domestic and international technology transfer and manufacturing support, including process, viral vector, and key reagents. The Process Engineer will be responsible for process and analytical root cause investigation and resolution at CMO’s. This person will analyze and summarize manufacturing data to support process monitoring and improvements, and perform technical support activities. The Process Engineer represents MPS in multidisciplinary internal/external project teams. This person will collaborate across all functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Process Engineer will play a key role in product life cycle, including development/characterization, commercialization, licensure, and evolution of cell therapy products. Primary Responsibilities Drive and manage successful global technology transfer and technical support of cGMP/GMP cell therapy bioprocessing at multiple internal and external manufacturing facilities. Apply superior process engineering knowledge throughout the clinical and commercial product life cycle: development, scale-up and scale-out, technology transfer, process validation, manufacturing, filing, and process optimization. Functions as a process and technology subject matter expert; provide on-the-floor and on-site technical support when required. Train and support GMP operators to implement new production and manufacturing procedures. Design and participate in technical, engineering, validation, and commercial manufacturing runs in the GMP manufacturing suites. Author experimental designs, technology transfer documents, validation protocols/ reports, non-conformances, investigations, and filings. Represent Manufacturing Process Sciences (MPS) and interface with other functions such as Process and Analytical Development, Manufacturing, Patient Operations, Supply Chain, Quality, and Regulatory. Assist in the development of optimized processes with improved process outcomes and reduced costs for manufacturing systems. Analyze manufacturing data to support investigations, process monitoring, optimization, and filings.

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