Project Leader, Drug Substance

Johnson & Johnson Innovative Medicine • Wilson, NC

2d • Onsite

About The Position

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 MedTech, 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 https://www.jnj.com/. 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

Requirements

• 15+ years of relevant experience and BEng, MEng, BS degree or equivalent OR 12+ years with advanced degree MS/MBA/Ph.D. or equivalent.
• Pharmaceutical Industry Experience
• Experience working on large complex capital projects.
• Industry leading expertise. Has established a national reputation in area of technical expertise. Demonstrates expert industry and company knowledge. Possesses an advanced understanding of and contributes to strategic business plans.

Nice To Haves

• Operations experience within a Life sciences or biopharmaceutical environment
• Experience on large complex capital projects
• 6-Sigma/Kepner-Tregoe or similar problem solving/decision making methodology training

Responsibilities

• 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&ID, 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 and development of all colleagues within the Project framework.
• Facilitate an environment of continuous improvement and innovation
• To provide leadership and a clearly identifiable work ethos
• Collaboration and teamwork
• Ensure Performance, Coaching & Development conversations and actions are completed timely and effectively
• Strategic Thinker
• Focus on Talent Development
• Integrity and Credo-based actions
• Work as a strategic partner with all other departments within the company and to align across Johnson & Johnson.
• Lead cross-functional teams as required

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level