The mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology, and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to get better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading research facility to overcome the complexicty and challenges of iPSC lineage specification. We will know we have succeeded when we can reliably and rapidly generate cell products that consistently produce positive outcomes in patients.
Within our Cell Therapy team in Gosselies (Belgium) there is one position immediately available: Director, Manufacturing Science and Technology (MSAT) in iPSC Cell Therapy. The selected candidate will report to the VP, Cell Technology. We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution.
For more information about the company, please visit our website at www.cellistic.com
As a Director of MSAT, you will be responsible for operationally focused on-site technical leadership in cell therapy, and key hands-on contribution to the development of Ncardia’s iPSC cell therapy manufacturing platforms. You will build-upon and lead a technical and execution team that ensures process scalability and manufacturability of Ncardia iPSC-based manufacturing platforms to successfully bring client cell therapy projects to the clinic.
You are self-motivated with a strong focus on innovation, and critical thinking, and with experience in a service organization or demonstratable soft skills that are needed for commercial projects. You are open-minded and a good communicator. You have a high level of energy that drives you and inspires others. You are a true team-player who enjoys working in close collaboration with colleagues across diverse company functions and clients. You can work in demanding and dynamic work environments and understand that this position requires flexibility. You have a problem-solving attitude, take initiatives, and think outside the box.
- Build-upon and lead a team responsible for process scalability, manufacturability and validation of Ncardia iPSC-based manufacturing processes (e.g., Fit/Gap analysis, process Failure Modes and Effects Analysis (FMEA)) to enable GMP compliant manufacturing
- Lead the process development and optimization of scaled (>10 L) and robust manufacturing platforms generating high quality cell therapy products
- Prioritize and execute MSAT tasks to fully meet commercial commitments on time
- Work effectively with the R&D process development team, as well as key suppliers and other stakeholders to meet manufacturing goals. Act as manufacturing technical subject matter expect (SME) for early-stage platform development activities.
- Ensure success of manufacturing operations through provision of high-quality batch records, robust processes and new technology implementation
- Recommend improvements for MSAT practices and procedures
- Author and/or review Process Flow Diagrams, Bill of Materials, Production Batch records, and other necessary documentation
- Perform process monitoring (manufacturing data summary and analysis, data presentation) and author campaign summary reports
- Anticipate, respond to, and permanently resolve issues that arise during production through use of master data, process and product monitoring, etc.
- Collaborate with Quality Assurance (QA) colleagues to ensure high-quality product and timely resolution of quality concerns, such as out of specification incidents (OOS), deviation and change management, and corrective and preventive actions (CAPAs)
- Ph.D. or M.S. in a scientific discipline and at least 8+ years of experience with large scale process development, MSAT or Manufacturing in biologics or vaccines
- Work experience in cell therapy product/process development or manufacturing is a plus
- Demonstrated ability to lead investigations, and perform process development, process monitoring, and process validation, FMEA-based risk assessment, technology transfer, and routine technical support
- Understanding of QbD approaches and implementation of creative problem solving
- Robust knowledge of US and EU cGMP CMC regulations/guidelines
- Demonstrated experience in building and leading technical teams and developing people
- Excellent organization, project and time management skills. Timelines may be demanding
- Capacity to innovate and contribute to company IP
- Good communicator and team-player
- Can maintain flexibility in a dynamic environment
- Proficiency in English, both written and spoken
- Excellent oral presentation and written communication skills
Job Location: Gosselies, Belgium
Position Type: Full-Time
Start Date: Immediately
We offer you a challenging position in a dynamic biotech company with room for personal growth and development. We provide a competitive salary package based on your education and experience.
Send your motivation letter with curriculum vitae to Elodie Noël at email@example.com