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Senior Process Optimization Engineer

Biotech - Mont-Saint-Guibert

NOVADIP-BIOSCIENCES is an innovative biotech company, based in the Walloon Region (Mont-Saint-Guibert), with a strong expertise in the development of novel regenerative medicines. This human-sized structure is a leader in first-in-class treatments for hard and soft tissues.

If you are sharing their vision of developing life-improving and life-saving products and if you are looking for new challenges amongst a dynamic and innovative team, consider collaboration with their fast growing company.

In order to support its exciting development, we are looking for a (m/f):

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Senior Process Optimization Engineer

Responsibilities :

As a Senior Process Optimization Engineer, you will be involved from design to validation, in the development of new manufacturing processes adapted to innovative cell therapy products.

Your main responsibilities are:

  • Provide leadership to work on development and continuous improvement of the manufacturing process.
  • Define industrial requirement for process automation in cGMP environment (technical and functional specifications).
  • Consulting engineering and/or equipment suppliers for development of automated close systems in production and quality control of cell-based therapies.
  • Set-up of development projects, coordination of external and internal dedicated team (ensure that industrial requirements and biological constraints are well understood), follow-up of projects execution, budget and reporting.
  • Contribute in implementation of new technologies and establish process validation plan in accordance with quality requirements and guidelines.
  • Set-up comparability studies to increase the operational scale of autologous manufacturing process (scale-out).
  • Ensure technology watch of the state-of-the-art technologies in process industrialization and automation of Advanced Cell Therapy Medicinal Products.
  • Manage selection of technologies and act as a scientific expert to ensure good decision making within the department.
Profile :
  • Engineer or PhD in Biology, Biochemistry, Biomedical Sciences or other related scientific field.
  • At least 5 years of relevant experience in the GMP biotech/pharmaceutical industry.
  • At least 5 years of relevant experience in process development in the field of cell therapy.
  • Strong knowledge of stem cell biology and processes for cell culture.
  • Strong knowledge of industrialization strategies and automation solution for cell therapy production.
  • Strong knowledge of quality requirements (GMP, clinical trials, comparability studies, process validation, aseptic practices) and working knowledge of requirements for aseptic manufacturing.
  • Ability to provide leadership and to manage priorities, follow assignments through to completion and meet deadlines.
  • Ability to work in a team and collaboratively in a matrix organization (R&D, QC, QA, RA).
  • Flexible for travelling, organized and pro-active.
  • Excellent oral and written communication skills in English, and ideally also in French.
Offer:
  • A diversified full-time permanent position within a high-potential innovative biotech company.
  • To work in a human-sized, dynamic, respectful and professional environment.
  • The opportunity to take part in a challenging scientific and business growth.
  • An attractive salary package in line with the position responsibilities and your experience.
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