Senior Project Director, Aseptic Campus

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose: 

​​The Senior Project Director, Aseptic Campus will lead the planning, execution, and delivery of a >$1B greenfield capital project to develop a state-of-the-art aseptic drug product manufacturing campus. The facility will include multiple aseptic drug product filling lines, formulation suites, utilities, warehousing, laboratories, and supporting infrastructure designed to meet global regulatory standards (FDA, EMA, and other regulatory agencies). This role is responsible for overall project governance, strategic decision-making, and delivery across engineering, procurement, construction, commissioning, qualification, and startup. The incumbent will drive transformational performance in delivery of Strategic projects through accelerated timelines taking advantage of digital technologies, adoption of best-in-class technology, cross-functional alignment with Operations and external functions, seamless execution and delivery of projects with stakeholders. The incumbent will report to VP, Strategic Capital Deployment in the Operations Transformation organization.​  

Responsibilities: 

• ​​Lead a team of project directors and managers to achieve the charter, priorities and milestones of strategic projects in various locations within the US.  
• ​Provide executive leadership for the full lifecycle of a >$1B greenfield pharmaceutical manufacturing campus project.   
• ​Establish and maintain project governance, reporting structures, and decision-making frameworks, ensuring continuous alignment with stakeholders 
• ​Lead integrated project teams across engineering, construction, CQV, quality, manufacturing, supply chain, and regulatory functions.   
• ​Serve as the primary interface for the project with executive leadership, steering committees, and key stakeholders. 
• ​Develop and execute the master project plan including scope, schedule, cost, risk management, contracting and resource strategies. Responsible to meet the key intent of the projects – best-in-class design, on time delivery, delivery of scope on or below budgeted cost and conformance to quality requirements. 
• ​Ensure alignment of facility design with long-term manufacturing network strategy and product pipeline requirements.   
• ​Oversee facility design for aseptic processing operations, including cleanroom classifications, contamination control strategy, filling systems, lyophilization, and sterile formulation  
• ​Ensure design supports qualification, regulatory approval and operational excellence from day one. 
• ​Manage capital expenditure including cost forecasting, change management, and financial reporting  
• ​Establish a risk-based CQV strategy that leverages digital technologies and enables accelerated timeline of facility and equipment qualification 
• ​Identify and mitigate technical, regulatory, schedule, and supply chain risks associated with large-scale pharmaceutical capital projects with plans for what-if scenarios 
• ​Build and lead a high-performing project organization including program managers, engineering leads, construction managers, CQV leads, and project controls professionals.   
• ​Foster a culture of safety, accountability, collaboration, and operational excellence.​ 

Qualifications

• ​​BS, Engineering or equivalent technical degree; Master’s degree in Engineering or MBA preferred 
• ​20+ years of experience as a Senior Engineering / Projects / Operations Leader across multiple technologies. 
• ​Proven leadership experience delivering mega-capital projects ($500MM – $1B+), preferably in biopharmaceuticals. 
• ​In-depth technical and operational expertise with aseptic drug product manufacturing operations and facilities 
• ​Proven inclusive management and leadership capabilities of large cross-functional