Process Technology Transfer Lead

at  Cellistic

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 getting better, more efficient treatments to patients faster. To achieve this mission, we are building a world-leading research facility to overcome the complexity 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. For more information about the company, please visit our website at www.cellistic.com
Within our MSAT team in Mont-saint-Guibert (Belgium) there is one position immediately available for a Process Engineer.
You will join an international and dedicated group of scientists, project leaders and laboratory technicians. We have expertise in bioprocess development, stem cell biology, cell-based assays, and GMP manufacturing. If this awakens your interest, please apply and support us to achieve our mission in bringing better therapies to patients faster.

QUALIFICATION & EXPERIENCE

• Education: PhD in Biological sciences or equivalent relevant working experience
• Strong Knowledge and min 5 years’ experience of pharmaceutical GMP and ATMP
• Strong Knowledge and min 5 years’ experience in process development & validation
• Strong knowledge and hands-on experience in technical transfer
• Strong Experience with project management and/or management of external activities
• Industrial experience with biologics, gene and/or cell therapy upstream process development including ownership of key process decisions. Prior experience with different modes of cultivation such as fed batch and perfusion and different technologies (ATF, TFF, G-rex) desired
• Strong organizational, troubleshooting and interpersonal skills along with excellent oral and written communication
• Demonstrated ability to work in a fast-paced, collaborative, and matrixed organization environment.
• Excellent interaction & communication skills, required to work in cross department projects, team spirit
• Work precisely according to procedures, rules and regulations

ADDITIONAL SKILLS

Since we are working in an international environment; proficiency in English, both written and spoken, is a prerequisite.
As a person, you are open-minded and a good communicator by nature. You have a high level of energy that drives you and inspires your colleagues. You thrive in a changing and dynamic work environment, and in a job that requires you to be flexible, take initiatives and think out of the box when challenges occur. You are a true team-player who enjoys working in close collaboration with colleagues in and out of the laboratory.

• Evaluate and optimize manufacturing processes to enhance efficiency, scalability, and quality.
• Work closely with process development and manufacturing teams to ensure a smooth transition from process development to full-scale GMP manufacturing.
• Develop and maintain comprehensive documentation, including technology transfer plans, protocols, reports, and standard operating procedures (SOPs).
• Ensure compliance with regulatory requirements, industry standards, and company policies.
• Act as a technical point of contact for Technical Transfer from internal stakeholders as well as external partners ensuring Operational & Scientific coordination.
• Develop and maintain comprehensive documentation, including technology transfer plans, protocols, reports, and standard operating procedures (SOPs).
• Ensure compliance with regulatory requirements, industry standards, and company policies.
• Define, coordinate, plan and control process optimizations and oversee batch failure investigations
• Support process optimizations and batch failures investigations
• Support deviations and CAPA related to process development & tech transfer activities
• Provide scientific coaching of junior profiles
• Work in a constructive and flexible way in project teams