Manufacturing Operations Lead

il y a 2 jours

Gent, Belgique Oxford Global Resources Temps plein

Location:
Ghent, Belgium
- Contact:
Dardo Helpers
- Job type:
Contract
- Contact phone:
+32 15 445 852
- Industry:
Pharmaceutical

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

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