Operations Start-up Lead

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 in a global, strategic collaboration to develop, manufacture, and commercialize a CAR-T cell therapy for BCMA. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.
We are currently in the built phase of a new innovative CAR-T project. A growing team of passionate talent is building the new sites in Ghent, developing, and refining all tools, processes and procedures that ensure a highly reliable, safe, and efficient production process.
This position will be supporting our two new manufacturing facilities (Obelisc & Tech Lane) in the leading Biotechnology Hub of Ghent, Belgium. You will have the unique opportunity to gain deep knowledge & expertise in a highly innovative and future oriented environment with the ability to profoundly impact the trajectory of health of our patients.

**Roles & responsibilities**:
The Operations Start-up Lead is an exempt level position with responsibilities for setting up the Operations System of a GMP personalized cell therapy sterile facility in Ghent.
- You play a central role in a project-based organization in which you collaborate with various other functions (such as quality assurance, quality control, health and safety, information technology, operations, planning, etc.) in a challenging, fast-paced project to support the successful transfer of the CAR-T process and the timely start of clinical and commercial manufacturing.
- You will lead the operations workstream and handle all requirements to prepare for clinical and commercial manufacturing, including but not limited to the following responsibilities:
- You support the design of facility, equipment and systems from an operational and business perspective and guide the organization towards a successful implementation.
- You contribute to the successful completion of the Technology Transfer milestones, including execution of Aseptic Process Simulation runs, Engineering, Stability and Comparability batches and Process validation runs in accordance with the project timelines.
- You support the lean design and implementation of Information Technology systems (SAP, MES, S/4,) including future releases to continuously improve performance and compliance.
- You immerse yourself in CAR-T processes, build up solid expertise, ensure timely development and implementation of a robust operational documentation framework, including operating procedures, work instructions, (electronic) batch records etc. and ensure adequate training of the organization.
- You instill a mindset of high standards of safety and cGMP compliance, ensuring the reliability of your operations and readiness for audits or inspections at all times.
- You build a sustainable partnership with Legend Biotech and develop an appropriate governance structure to monitor the daily operational performance. You are constantly on the lookout to identify and implement opportunities for improvement.
- You will have the opportunity to coach and develop a small team of (3 to 5) people.

**Qualifications**:

- Minimum 7-10 years experience
- You have a Master-Degree in a scientific or technical field (Engineering, Bioscience Engineering, Industrial Engineering, Pharmacy, Biochemistry)
- You place our patients are at the center of everything you do
- You embrace diversity, equity, and inclusion
- You have strong knowledge of aseptic manufacturing and experience in project management
- You have a start-up/can-do mindset, and you proactively search for solutions
- You are able to prioritize and provide clear instructions to team members
- You thrive in a rapid changing environment and lead as a change agent to promote flexibility, creativity, and accountability while at the same time handling procedures/guidelines which require strict execution
- You possess strong verbal and written communication skills with ability to influence without authority
- Experience in equipment/systems commissioning/qualification/validation, IT systems, cell therapy (CAR-T) is an asset