Project Leader, Drug Substance

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 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.

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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions 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 athttps:// 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 15000 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&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 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 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

QUALIFICATIONS:
Education & Experience:

• 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.

Knowledge:

• 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.

Desirable:

• 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

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

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 Companys 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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