Senior Project Director, Aseptic Campus

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.
• 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.
• 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 teams and the ability to effectively interact and communicate with senior leadership and executives from strategic partners and authorities
• Demonstrated experience managing Engineering, EPC/EPCM contractors and global equipment vendors
• Results-oriented leadership with outstanding negotiation skills and risk-based decision making is required
• Ability to mentor and develop next generation of leaders
• Travel within the US outside the US for reviews/workshops/visits to vendor facilities will be required
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs.
• Note: No amount of pay is consider

Benefits

Additional Information

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.

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