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Process Engineer iPSC-based Cell Therapy R&D

Gosselies, Belgium

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: 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.

Interested?

Send your motivation letter with curriculum vitae to: careers@ncardia.com