Manager Manufacturing Programs – Process Owner Team

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  Doctorate degree OR 

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  Master's degree and 3 years of biotechnology or pharmaceutical manufacturing experience OR 

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  Bachelor's degree and 5 years of biotechnology or pharmaceutical manufacturing experience OR 

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  Associate's degree and 10 years of biotechnology or pharmaceutical manufacturing experience OR 

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  High school diploma / GED and 12 years of biotechnology or pharmaceutical manufacturing experience 

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  In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above 

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• 7+ years of biotechnology or pharmaceutical manufacturing experience with progressively increasing responsibility. 

• Demonstrated people leadership experience managing, coaching, and developing technical teams. 

• Strong technical expertise in either Upstream & Services manufacturing operations or Downstream manufacturing operations. 

• Experience with GMP manufacturing operations, process stewardship, and manufacturing support. 

• Experience supporting operational readiness activities, including water runs, dry runs, equipment testing, and startup support. 

• Experience with CAPA implementation, CAPA applicability assessments, effectiveness checks, risk assessments, and root cause analysis support. 

• Knowledge of drug substance manufacturing equipment, process flows, and manufacturing operations. 

• Experience supporting Manufacturing Execution Systems (MES) and Electronic Batch Records (EBRs) within a GMP manufacturing environment. 

• Knowledge of single-use technologies and Bill of Material (BOM) structures. 

• Experience partnering with Process Development on facility fit assessments, process implementation, and knowledge transfer activities.