HEAD, NEW SITE STARTUP ATSC

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The ATSC New Site Project Leader is fully accountable from start to regulatory approval for leading the project team that will deliver a New Greenfield CART Manufacturing facility to be located in the USA (TBD).
This plant will supply lifesaving medicines for patients for J&JIM.
The new site startup leader will be responsible for shaping the overall planning of the project, development of a new manufacturing site location including engineering, construction, equipment delivery, commissioning & qualification, hiring and training program for all new J&J employees, startup and FDA regulatory approval of the first product.
The plant will employ ~850 FTE when in full operation (% - JNJ vs Contractor) and will require approximately + engineers, equipment vendors and craftsman to design & build the facility.
Overall schedule for new facility from CAR) to commercial FDA approval is 5 years.
Strategic Planning.
Develop and implement the strategic vision for cell therapy site build engineering, aligning it with the organization's objectives and growth plans.
- Evaluate and recommend suitable sites for cell therapy facilities, considering factors such as location, infrastructure, regulatory compliance, and scalability.
- Work closely with cross-functional teams, including scientists, regulatory affairs, and operations, to ensure alignment of engineering activities with business goals.
Project Management.
Plan, coordinate, and oversee all aspects of cell therapy site build projects, including facility design, construction, commissioning, and validation.
- Collaborate with architects, contractors, vendors, and regulatory authorities to ensure compliance with relevant guidelines, codes, and regulations.
- Develop project budgets and timelines, monitor progress, and manage resources to ensure timely and within-budget project completion.
Engineering and Design.
Provide engineering expertise in the design and layout of cell therapy facilities, ensuring compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and other industry standards.
- Review engineering drawings, equipment specifications, and performance criteria to ensure the functional requirements of cell therapy manufacturing and research processes are met.
- Coordinate with internal stakeholders and external consultants to optimize facility layout, infrastructure, utilities, HVAC systems, and cleanroom environments.
Regulatory Compliance.
Stay up-to-date with applicable regulations, guidelines, and industry best practices related to cell therapy site build engineering and ensure compliance.
- Collaborate with regulatory affairs and quality teams to manage inspections, audits, and any necessary corrective actions to maintain regulatory compliance.
- Establish quality management systems and processes to support site build activities, ensuring documentation completeness and adherence to relevant regulations.
Team Leadership.
Lead a team of site build engineers, architects, and project managers, providing clear direction, guidance, and mentorship.
- Foster a collaborative and inclusive work environment, promoting effective communication and teamwork.
- Identify training and professional development opportunities for team members to enhance their skills and knowledge.
Additional 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 team to identify and manage risk throughout project.
Remove barriers to success and be available to support team.
Formally close project and recognize success including benchmarking.
Ensure required project financials and schedule controls.
Cashflow management is essential.
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, etc.
– to ensure alignment with stated J&J Corporate Goals.
The anticipated base range for this role is.
$.
Qualifications University/Bachelors Degree in Science/Engineering or Equivalent with 10+ Biotech/ Pharmaceutical experience or Masters degree in Engineering, with 10+ years Biotech/ Pharmaceutical experience or equivalent industry experience Preferred Professional Engineering License or PMP Experience building a new greenfield site Hands-on experience in Manufacturing Operations and/or R&D in a biopharmaceutical manufacturing setting (ie.
cell/gene therapy products, vaccines, or any other advanced therapy products) Hands-on experience running large capital projects.
Strong leadership experience working with both contractors and consultants Ability to lead and influence multidisciplinary, cross-functional teams Project-dependent travel 25%+ Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Disclaimer.
This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job; it is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards.
The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole.
This document is not a contract for employment.