As the Autologous CART operations director, you are accountable for the Operations of the Ghent Obelisc cell processing business unit, and this in close collaboration with our partner Legend Biotech.
In a challenging, fast-paced environment, you play a central role in the organization, collaborating with various other functions (quality assurance, quality control, health and safety, maintenance, planning, information technology etc.) to support the successful transfer of the CAR-T process, the timely start of clinical and commercial manufacturing, the operations oversight and the further improvement of the operations.
You take ownership of and will handle all related requirements, including the following responsibilities:
- Responsible for the operations oversight unit, including management of daily operations.
- Responsible to manage the relation with Legend Biotech, acting as the account manager of the Ghent Obelisc business unit by building a sustainable partnership with Legend Biotech and developing an appropriate governance structure to monitor the daily/weekly/monthly operational and quality performance.
- Secure cGMP through regular shopfloor tours with focus on housekeeping, adherence to procedures and witnessing of aseptic techniques.
- Deliver on the Ramp Up & Capacity plan to bring the unit to full capacity.
- Install a mindset of high standards on E&HS and cGMP compliance, ensuring the reliability of operations.
- Review and approve of all documentation related to the operations area, including FMEA’s, SOP’s, Protocol’s and Changes.
- Act as a spokesperson during health authority inspections.
- Identify risks and opportunities in relation to process, contamination, cross-contamination and mix-up control on the shop floor and drive improvements in close cooperation with operations, QA, QC, maintenance and engineering.
- Provide direction in investigations related to operations.
- Lead a team of engineers linked to cell processing operations.
- Manage relevant stakeholders of the matrixed organization (JnJ and Legend Biotech) to ensure successful process and execution.
- Manage plant’s operational budget.
- Minimum 10 years of experience in operations leadership of aseptic GMP facilities.
Qualification & skills
- You have a master’s degree in a scientific or technical field related to cell processing (Engineering, Bioscience Engineering, Pharmacy, Biochemistry …).
- Proven track record leading aseptic operations is a must, ATMP experience is a plus.
- You are comfortable to work in a rapidly changing environment. You have proven experience as a change agent promoting flexibility, creativity, and accountability in a GMP regulated environment.
- You are a team-player, sensitive to team dynamics and have a proven track record on influencing without authority, as you will work in a matrixed organization in close collaboration with our partner Legend.
- You place the patients at the center of everything you do.
- You embrace diversity, equity, and inclusion.
- You have a start-up/can-do mindset, and you proactively search for solutions.
- Your verbal and written English is fluently, you can express yourself in Dutch.
- Experience in one or more area’s in cell therapy operations (autologous CAR-T) is a plus.
- Ability to work out of Ghent.
- The opportunity to participate in a progressive treatment that gives hope to patients in need.
- The ability to help shape a new venture from the start.
- An innovative working environment.
- Training on the job for this specific treatment.
- Opportunities to continue to develop and grow in an extensive and strong organization.
- An open-ended contract and a competitive remuneration package.