Manufacturing Operations Lead

il y a 2 semaines

Gent, Belgique Oxford Global Resources Temps plein

**Manufacturing Operations Lead - Advanced Therapies**:

- 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

  • Manufacturing Operations Lead

    il y a 2 semaines

    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...

  • Manufacturing IT Lead

    il y a 1 semaine

    Gent, Belgique Robert Half Temps plein

    Robert Half Management Resources is momenteel op zoek naar een Manufacturing IT Lead (m/v/x) op zelfstandige basis (ad interim) voor een periode van 6 maand.Onze klant is gevestigd in de regio Gent.Als Manufacturing IT Lead ben je verantwoordelijk voor:Leidinggeven aan IT-teamOndersteunen bij de S/4HANA-migratie en MES-roll-outPrioriteiten afstemmen en...

  • Manufacturing IT Lead

    Il y a 12 minutes

    Gent, Belgique Robert Half Temps plein

    Onze klant is gevestigd in de regio Gent. Manufacturing IT Lead Functieomschrijving Als Manufacturing IT Lead ben je verantwoordelijk voor: - Leidinggeven aan IT-team - Ondersteunen bij de S/4HANA-migratie en MES-roll-out - Prioriteiten afstemmen en processen faciliteren als brug tussen IT & business - Beheer, configuratie en optimalisatie van applicaties...

  • Operations Start-up Lead

    il y a 2 semaines

    Gent, Belgique Johnson & Johnson Temps plein

    CAR-T is an innovative treatment, which uses the power of the patient’s own immune system. A patient’s T-cells are genetically modified to eliminate cancer cells. This ground-breaking, innovative technology provides hopeful prospects to patients where other therapies have failed or fail to provide adequate results. Janssen and Legend Biotech have entered...

  • Operations Support Supervisor

    Il y a 26 minutes

    Gent, Belgique HAYS Temps plein

    Operations Support Supervisor | Gent | Shift System | EN - NL Are you eager to contribute to the manufacturing of innovativetreatments? Join a cutting-edge biotechnology company specializing in celltherapies. In a highly regulated GMP environment, you will supervise productionsupport operations. This role places you at the heart of manufacturinglife-changing...

  • Associate Scientist

    il y a 2 semaines

    Gent, Belgique Ardena Temps plein

    **About us** **Ardena **is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...

  • Be: Operations Investigations Supervisor

    Il y a 25 minutes

    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer...

  • Mes Program Business Lead

    il y a 2 semaines

    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson is currently seeking a MES Readiness Business Lead to join our CAR-T Operations team located in Ghent, Belgium. As MES Readiness Business Lead you are accountable for the delivery of the MES system to support clinical and commercial CAR-T manufacturing at the CAR-T Ghent sites. Your main responsibilities include: - Leading the...

  • Operations Project Expert

    Il y a 25 minutes

    Gent, Belgique Legend Biotech EU Temps plein

    **Company Information** Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer...

  • Clinical Operations Development Lead

    Il y a 23 minutes

    Gent, Belgique Argenx Temps plein

    We are currenty looking for a Clinical Operations Development Lead (CODL) to strengthen the Global Clinical Trial Operations team. - The Clinical Operations Development Lead is responsible for the oversight of the clinical related activities within a specific therapeutic indication for an asset (CODL) or across all indications for an asset (X-indication...