Project Leader, Drug Product

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Project/Program Management Group

Project/Program Management

Professional

Wilson, North Carolina, United States of America

Johnson & Johnson is recruiting for the Project Leader, Drug Product located in Wilson, NC.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Project Leader is an individual who is fully accountable from start to regulatory approval for leading a project team that will deliver the Drug Product facility to include Manufacturing capability for Filling, Optical inspection, Device assembly, packaging & warehouse. In addition, the delivery of central Utility plan, Laboratory and administration capability to support the manufacturing facility.

This role will be based full time in Wilson, NC and will require up to 35% travel in the first two years of the project to support the project. This role is on site, five days per week.

• No accident during from start of engineering thru to regulatory approval
• Execution of New Drug Product Facility at the existing Wilson, NC site including design, construction, commissioning, qualification, startup, operational readiness preparation, and regulatory approval of the facility.
• Supervision of Overall Team working on the New Drug Product facility
• J&J / Contractor Headcount, Outside Engineering & Construction Headcount.
• Ensure diverse hiring, onboarding, and training to support the operations startup – 345 FTE (J&J) and 140 (Contractor) at full operation.
• Operational Readiness for Plant Startup FDA regulatory approval Ensure overall performance for Schedule, Capital and Operational Expenses thru FDA Approval, and Target Cost of Goods Price.
• Good team development within the project team and good external communication / partnership with local neighbors and regulatory authorities.

• Develop and align with the Sponsor on the Project Case and Final Project Objectives
• Lead and facilitate Project / Site Leadership Alignment Meeting
• Establish roles and responsibilities for all core team members
• Align and motivate core team members to feel fully accountable and engaged towards delivering their respective individual accountabilities
• Lead the core team through regular core team meetings
• Lead team to identify and manage risk throughout project
• Manage relationship with sponsor, including regular reviews
• Remove barriers to success and be available to support team
• Formally close project and recognize success including benchmarking
• Facilitate and manage Core Project Team and ensure coordination around the Project Objectives
• Lead the project communication process
• Ensure required project financials and schedule controls.
• Cashflow management is essential.
• Participate in all Principals meetings
• Work with core team to ensure achievement of agreed FEL sub-project FPOs
• Maintain budget, schedule, and…