Director, Capital Project Management

General Description:

The Director, Capital Project Management is responsible for the delivery of major capital projects supporting expansion of manufacturing capacity within Global Technical Operations. This specific role will lead the execution of the recently announced $300M Capital project to expand small molecule drug product manufacturing at the Hopewell, NJ site. Experience in successfully delivering multi-hundred million dollar Capital projects is a key requirement for the position. The Capital project manager is responsible for leadership and accountability for project scope, schedule, budget, design & construction firm management, construction execution, commissioning, qualification, and operational readiness activities. This position works closely with Operations, Facilities, Quality, Validation, EHS, and external firms to ensure successful delivery of cGMP-compliant manufacturing facilities while delivering on safety, quality, cost, schedule, and business readiness.

This position is located at the Hopewell, NJ site with flexibility to periodically travel to support ongoing or proposed projects across the company.

Essential Functions of the Job:

• Accountable for overall project scope, schedule, budget, risk, and change management.

• Lead engineering design firms, construction managers, contractors, and other project consultants.

• Direct all phases of facility delivery, including conceptual design, detailed engineering, procurement, construction, commissioning, qualification, and startup.

• Ensure compliance with FDA, EMA, cGMP, safety, environmental, and corporate standards.

• Establish project governance, reporting, and executive communications.

• Manage capital expenditures and forecast project spending.

• Lead commissioning, qualification, and handover to manufacturing operations.

• Coordinate utilities, process equipment, automation, validation, quality, EHS, and operational readiness activities.

• Build and lead project engineering teams where required.

• Drive contractor safety performance and construction quality.

• Ensure projects are delivered on time, on budget, and ready for commercial manufacturing operations.

Qualifications:

• Bachelor's degree in Engineering (Mechanical, Chemical, Civil, Electrical, or related discipline) required.

• Professional Engineer (PE) license and/or PMP certification preferred.

• 10+ years of progressive engineering, construction, and/or capital project management experience.

• 5+ years leading large-scale multi-hundred million dollar capital projects in pharmaceutical industry.

• Experience managing projects through the full lifecycle, including concept design, detailed engineering, procurement, construction, commissioning, qualification, startup, and handover to operations.

• Experience managing design firms, construction management contractors, and specialty subcontractors.

• Proven track record of delivering projects on schedule and within budget.

• Strong understanding of pharmaceutical manufacturing facility design and operation, specific knowledge of small molecule drug product operations is an advantage.

• Knowledge of GMP regulations, FDA requirements, ISPE guidelines, and validation principles.

• Experience with:

• Pharmaceutical manufacturing processes

• Cleanrooms and controlled environments

• Process equipment installations

• HVAC systems

• Clean utilities

• Site infrastructure and central utility systems

• Electrical distribution and backup power systems

• Experience supporting commissioning, qualification, validation, and operational readiness activities.

• Ability to lead cross-functional teams consisting of Engineering, Facilities, Manufacturing, Quality, Validation, EHS, Supply Chain, and external partners.

• Strong contractor management and construction oversight capabilities.

• Experience establishing project governance, reporting metrics, and executive-level communications.

• Demonstrated ability to identify and mitigate project risks while managing scope changes and budget impacts.

• Experience developing project plans, milestones, schedules, budgets, and critical path management

• Experience managing significant capital budgets and forecasting project expenditures.

• Strong understanding of contract management, bid evaluations, procurement strategies, and vendor negotiations.

• Ability to evaluate project tradeoffs and make risk-based decisions balancing safety, quality, schedule, and cost.

• Strategic thinking and execution.

• Strong stakeholder management and influencing skills.

• Ability to operate effectively in a fast-paced, matrixed global organization.

• Exceptional communication and presentation skills.

• Demonstrated ability to build high-performing project teams and foster a culture of safety, accountability, and continuous improvement.

Supervisory Responsibilities:

• Yes (Indirect via contract staff)

Computer Skills: PC, including MS Office Suite

Travel: ~10-15% travel required

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.