Senior Manager – Manufacturing Programs - Process Owner Organization

Doctorate degree and 2 years of  biotechnology or pharmaceutical industry experience
OR
Master’s degree and 6 years of biotechnology or pharmaceutical industry experience
OR
Bachelor’s degree and 8 years of  biotechnology or pharmaceutical industry experience
OR
Associate’s degree and 10 years of biotechnology or pharmaceutical industry experience
OR
High school diploma / GED and 12 years of biotechnology or pharmaceutical industry experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.  Your managerial experience may run concurrently with the required technical experience referenced above 

• 8+ years related work experience in biotechnology or pharmaceutical manufacturing with progressively increasing responsibility. 

• Prior people leadership experience managing and developing technical teams. 

• Strong understanding of GMP manufacturing operations supporting Upstream, Downstream, and Services Drug Substance Unit Operations. 

• Experience with process ownership, manufacturing support, and technical process stewardship. 

• Experience supporting digital manufacturing systems, electronic batch records (EBRs), manufacturing execution systems (MES), and associated process implementation activities within a GMP manufacturing environment. 

• Experience authoring, approving, and governing manufacturing SOPs and GMP documentation within Quality Systems (i.e. Veeva, Documentum, etc.).  

• Experience leading manufacturing CAPAs/change controls and implementation activities. 

• Experience supporting operational readiness activities, including dry runs, water runs, process implementation, and startup support. 

• Experience partnering with Supply Chain organizations to support BOM management, material readiness, and manufacturing execution.