Description
The Cell Therapy Manufacturing CAPEX Project Manager will lead capital expenditure projects for new and existing cell therapy manufacturing facilities. This role requires hands-on experience in cell therapy operations, equipment selection and installation, facility and cleanroom setup, as well as expertise in critical utilities and quality systems. The ideal candidate thrives in a fast-paced environment, manages complex timelines, and ensures projects are delivered on schedule, within scope, and on budget.Key Responsibilities
- Lead end-to-end project management for cell therapy manufacturing CAPEX initiatives, from project initiation through validation and handover.
- Develop and maintain detailed project plans, schedules, and budgets, ensuring alignment with business objectives and regulatory requirements.
- Oversee the design and setup of cell therapy manufacturing spaces, including cleanrooms, equipment layout, and utility connections.
- Manage the procurement, installation, commissioning, and qualification (IQ/OQ/PQ) of cell therapy manufacturing equipment, QC equipment, and automation/APS systems.
- Coordinate with cross-functional teams (Manufacturing, Engineering, Quality, Supply Chain, Facilities) to drive timely project execution and resolve technical challenges.
- Lead or support the design, installation, and qualification of HVAC systems and critical utilities (e.g., CDA PQ, compressed gases, environmental controls).
- Ensure all facility and equipment setups comply with cGMP, safety, and regulatory standards.
- Track project risks, develop mitigation strategies, and provide regular status updates to stakeholders.
- Support audits, inspections, and documentation for CAPEX projects, ensuring readiness for regulatory review.
- Facilitate project team meetings, drive action items to completion, and foster a culture of accountability and continuous improvement.
Requirements
- Proven experience managing CAPEX projects in a cell therapy or advanced therapy manufacturing environment.
- In-depth knowledge of cell therapy processes, equipment, and facility requirements, including cleanroom and critical utility setup.
- Strong understanding of HVAC, CDA PQ, and other facility infrastructure relevant to cell therapy manufacturing.
- Direct experience with QC equipment, automation/APS systems, and facility commissioning and qualification.
- Demonstrated ability to manage fast-paced project timelines and adapt to changing priorities.
- Excellent communication, organizational, and leadership skills, with a track record of cross-functional collaboration.
- Familiarity with cGMP, safety, and regulatory requirements for cell therapy manufacturing.
- Bachelor’s degree in engineering, life sciences, or related field; advanced degree or PMP certification is a plus.
Preferred Qualifications:
- Experience with both autologous and allogeneic cell therapy manufacturing environments.
- Prior involvement in facility design, construction, or expansion projects.
- Knowledge of process automation, digital manufacturing solutions, and advanced project management tools.
Hourly Range: $90-110/hr
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
