Senior Project Director, Aseptic Campus

Purpose:
- Lead planning, execution, and delivery of a >$1B greenfield capital project to develop a state-of-the-art aseptic drug product manufacturing campus meeting global regulatory standards.
- Provide overall project governance, strategic decision-making, and delivery across engineering, procurement, construction, commissioning, qualification, and startup.
- Drive transformational performance via accelerated timelines, digital technologies, best-in-class technology, and cross-functional stakeholder alignment.

Responsibilities:
- Lead a team of project directors and managers to achieve strategic project charter, priorities, and milestones across US locations.
- Provide executive leadership for full lifecycle delivery of a >$1B greenfield pharmaceutical manufacturing campus project.
- Establish and maintain project governance, reporting, and decision-making frameworks aligned with stakeholders.
- Lead integrated project teams across engineering, construction, CQV, quality, manufacturing, supply chain, and regulatory.
- Serve as primary interface with executive leadership, steering committees, and key stakeholders.
- Develop and execute master project plan (scope, schedule, cost, risk, contracting, resources); ensure best-in-class design, on-time delivery, on/below budget, and quality conformance.
- Ensure facility design aligns with long-term manufacturing network strategy and product pipeline needs.
- Oversee aseptic processing facility design (cleanroom classifications, contamination control, filling systems, lyophilization, sterile formulation).
- Ensure design supports qualification, regulatory approval, and operational excellence from day one.
- Manage capital expenditures (cost forecasting, change management, financial reporting).
- Establish risk-based CQV strategy leveraging digital technologies to accelerate facility/equipment qualification.
- Identify and mitigate technical, regulatory, schedule, and supply chain risks; develop what-if scenarios.
- Build and lead a high-performing project organization (program managers, engineering leads, construction managers, CQV leads, project controls).
- Foster safety, accountability, collaboration, and operational excellence.

Qualifications:
- BS in Engineering (or equivalent technical degree); Master’s in Engineering or MBA preferred.
- 20+ years as a Senior Engineering/Projects/Operations leader across multiple technologies.
- Proven experience delivering mega-capital projects ($500MM–$1B+), preferably in biopharmaceuticals.
- In-depth technical and operational expertise in aseptic drug product manufacturing operations and facilities.
- Inclusive leadership of large cross-functional teams; ability to communicate effectively with senior leadership and external partners/authorities.
- Experience managing Engineering and EPC/EPCM contractors and global equipment vendors.
- Results-oriented leadership with strong negotiation skills and risk-based decision-making.
- Ability to mentor and develop next-generation leaders.
- Ability to travel within the US (including outside the US) for reviews/workshops/visits to vendor facilities.