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Job #02714

About our client Our client is a rapidly growing pharmaceutical company headquartered in the Midwest that is focused on the development and commercialization of therapeutic radio-pharmaceuticals for the US nuclear medicine market. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Director of Operations/Engineering Midwest, USA Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee overall cGMP plant management and support services functions for injectable drug products 2) Assist in developing budget projections, material and staffing forecasts 3) Develop production schedules to meet clinical supply goals for project teams and CMO activities 4) Ensure that the required engineering runs performed to study process improvements and changes to existing processes are performed to meet the needs of commercial manufacturing 5) Assist with designing and build-out of a facility expansion 6) Develop, implement and maintain personnel policies, procedures and production control systems 7) Assist with technology transfer of manufacturing process to commercial manufacturing or to outside contract manufacturing sites (when required) 8) Ensure cGMP compliance such that all production equipment is properly validated and production processes meet quality standards 9) Measure and appraise subordinates' performance against job duties and objectives 10) Provide accurate feedback 11) Recommend/approve merit increases, promotions, hires and terminations Requirements 1) BS/BA in a technical discipline preferred 2) Minimum 15 years of experience in the production of bio-pharmaceuticals with a minimum 8 years of supervisory experience in a GMP production environment 3) Experience in a successful facility licensure a plus 4) Detailed process and equipment knowledge of clean rooms and barrier isolator technology 5) Good understanding of GMP requirements for the production of injectable drug products 6) Demonstrated supervisory skills 7) Excellent communication skills (oral and written)