Senior Process Optimization Engineer
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):
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.
- 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.
- 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.
Please send your CV together with an adapted cover letter via http://www.pahrtners.be/job/senior-process-development-engineer/ or to email@example.com
Your application and related information will remain strictly confidential.