As a process engineer in hiPSC-based Process Development your key responsibilities will be in developing suspension-based and/or adherent culture manufacturing processes. In this role you will focus on the automation and scale-up of bioprocesses for manufacturing products from pluripotent stem cells to include but not limited to immunotherapy, CAR-T, and NK cells. You will also provide technical expertise in cGMP cell manufacturing including bioreactors, cell washing and concentration technologies, and fill/finish operations.
You are self-motivated and energetic with a strong focus on innovation, and critical thinking, and with experience in a service organization or demonstrable soft skills that are needed for commercial projects. As part of the job responsibility includes hands-on processes development, the preferred candidate is a motivated researcher with desire to work in a laboratory, including occasional cell maintenance during the weekend.
Responsibilities
- Lead and deliver process optimization studies focused on scale-up of novel hiPSC-derived cell types according to defined timelines, budget and milestones. Customer sponsored projects are part of the position
- Evaluate and implement technologies to improve consistency, increase scale, and facilitate cGMP compliance of bioprocesses for manufacturing hiPSC-derived therapeutics
- Develop scale-down models for process optimization studies
- Evaluate and implement process analytical technologies (PAT) for improved monitoring and control of stem cell bioprocesses
- Ensure accurate internal data reporting
- Contribute to or lead scientific presentations and collaboration with external stakeholders
- Write protocols, technical reports, and Standard Operating Procedures (SOPs)
- Collaborate with project teams to integrate processes
- Participate in technology transfer of processes and equipment to the Manufacturing group
Qualifications
- Ph.D. in biology, bio-engineering, or other relevant discipline and/or relevant equivalent working experience
- Demonstrated proficiency in mammalian cell culture processes - preferably with bioreactors
- Relevant experience or understanding of the following:
- Process development as a member of product/process development teams
- QbD/DE approaches
- cGMP biomanufacturing
- Pluripotent stem cells and/or differentiation
- Immuno-biology, immuno-therapy, and related manufacturing techniques
- Attention to detail, and problem-solving
- 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
Job Location: Mont Saint Guibert, 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.
Interested?
Send your motivation letter with curriculum vitae to: careers@cellistic.com