Project Leader, Drug Substance

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Job Function:
Project/Program Management Group
Job Sub Function:
Project/Program Management
Job Category:
Professional
All Job Posting Locations:
Wilson, North Carolina, United States of America
Job Description:

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world 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 Substance facility to include Manufacturing and Warehouse capabilities for a 6 x 15,000 L + 1 Downstream Purification located in Wilson, NC. The project also included 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.

The Final Project Objectives and overall responsibilities are:

• No accident during engineering through regulatory approval.
• Execution of New Drug Substance 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 - 550 FTE (J&J) and 200 (Contractor) at full operation.
• Operational Readiness for Plant Startup
• FDA regulatory approval
• Ensure overall performance for Schedule, Capital and Operational Expenses through 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

KEY ACCOUNTABILITIES:

• 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 team meetings.
• Lead team to identify and manage risk throughout project.
• Manage relationships with sponsors, 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 financial 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 ensure quality completion of deliverables.
• Ensure occurrence of the Strategic Project Execution Planning session and confirm participation of the Sponsor and all Key Stakeholders
• Manage communications with external regulatory authorities and the local community to ensure alignment with project objectives.
• Manage relationship with J&J Corporate groups - E&PS, E&HS, S&, IT, etc.
  
  - to ensure alignment with stated J&J Corporate Goals.
• Manage interface between Project Team, Site Operations and Global Planning for new capacity ramp up.

LEADERSHIP RESPONSIBILITIES / INDIVIDUAL CONTRIBUTION

• Leadership and development of all colleagues within the Project framework.
• Customer focused
• Results Driven
• Facilitate an environment of continuous improvement and innovation
• To provide leadership and a clearly…