Lead the operational charge in building and scaling two innovative biological manufacturing centers, shaping the future of immunotherapy and directly impacting the trajectory of patient health
Job description
We are seeking a dynamic and experienced Project Lead Operations to join the efforts in Ghent, Belgium. As part of the Operations workstream, you will play a crucial role in the start-up and scale-up of two CAR-T manufacturing centers. This is a unique opportunity to contribute to groundbreaking technology that positively impacts the lives of patients.
Responsibilities
- Drive operational projects related to the ramp-up program, ensuring effective execution.
- Collaborate with cross-functional teams to implement changes and improvements.
- Support the design and implementation of IT systems (SAP, MES, S/4, etc.) to enhance performance and compliance.
- Ensure continuous improvement of IT systems through future releases.
- Provide expertise in Technical Operations discussions, drawing from GMP knowledge of ATMPs and extensive process knowledge of cell and gene therapy products.
- Develop and implement a robust operational documentation framework, including operating procedures and batch records.
- Conduct training sessions to ensure organizational competence.
- Oversee the end-to-end flow of all materials in the operational area.
- Identify and manage risks related to process, contamination, and control on the shop floor.
- Uphold high standards of safety and cGMP compliance.
- Ensure readiness for audits and inspections at all times.
Profile
- Minimum 8 years of relevant work experience, preferably in aseptic manufacturing.
- Master's Degree in a scientific or technical field.
- Strong project management skills.
- In-depth knowledge of aseptic manufacturing.
- Excellent communication and leadership skills.
- Experience with team-based collaborations.
- Experience with equipment/systems commissioning/qualification/validation.
Benefits
- Directly employed by Oxford.
- Possible: long-term perspective;
- Mobile phone provided & monthly phone contribution;
- Monthly allowance for meal vouchers;
- Travel allowance;
- Hospital & Group insurance;
- Opportunities for education and training;
- Fulltime position, daytime work;
- Region: Gent
Vacancy number: 23870
The need of the existing right to live and work in Belgium
