- Provide leadership to work on development and continuous improvement of the manufacturing process.
- Set-up of process development projects, conduct and follow-up of projects execution, provide timelines, budget and reporting.
- Establish process validation plan in accordance with quality requirements and guidelines.
- Set-up comparability studies to increase the operational scale of autologous and allogeneic manufacturing processes (scale-out and scale-up).
- Ensure scientific watch of the state-of-the-art technologies in process optimization and industrialization for aseptic manufacturing of Advanced Cell Therapy Medicinal Products.
- Contribute to the implementation of such new technologies in the manufacturing process through process development projects.
- Manage selection of appropriate technologies and act as a scientific expert to ensure good decision making within the department.
- Carry out technical and regulatory surveillance (EMA, FDA)
- Master or PhD in Biological Sciences or related field.
- Minimum 5 years of experience in manufacturing process development and optimization or in a similar function, preferentially in pharmaceutical industry.
- Strong knowledge in cell culture techniques.
- Strong knowledge of quality requirements (GMP, comparability studies, process validation) and working knowledge in aseptic practices.
- Ability to manage priorities, follow assignments through to completion and meet deadlines.
- Teamwork and leadership experience, preferably in a biotech (start-up) environment.
- Ability to work in a team and collaboratively in a matrix organization (Discovery, QC, QA, RA).
- Excellent organizational and oral/written communication skills in English, and ideally also in French.
- Flexibility to operate in multitasks environment.
- A full-time permanent position (40h/week) 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.