- Define the in vitro product characterization strategy of Novadip Biosciences experimental products, mainly the scientific approach leading to definition of the product mode of action and composition.
- Participate in the definition of the product critical attributes in order to support quality control and stability studies.
- Design of studies, ensure scientific leadership on projects.
- Autonomously organize and carry out the activities and provide assistance to laboratory analysts.
- Identification of analytical methods supporting the product characterization strategy.
- Participate in the revision, validation and approval of results and documentation (procedures, protocols, reports).
- Manage outsourced activities or collaborative studies with external partners.
- Carry out technological and regulatory surveillance (EMA, FDA, ICH),
- Provide scientific expertise to projects.
- Project management (timelines, results, documentation, budget) and present/discuss results in project team meetings.
- Interact with RA team for file preparation and submission.
- Master’s degree or PhD in relevant scientific discipline (e.g. Medical Science, Life Science Biochemistry).
- Minimum 5 years of experience in a similar function, preferentially in (bio)pharmaceutical industry
- Scientific knowledge in the field of stem cells and bone biology (e.g. musculoskeletal biology, physiology, metabolism) is a strong asset.
- Experience in molecular biology techniques (cell culture, ELISA, multicolor FACS, qPCR), (immuno-) histological analysis and data analysis using statistic software.
- Knowledge of GxP standards is an asset.
- Rigorous, perseverant, proactive and following to the end every subject.
- Teamwork and leadership experience, preferably in a biotech (start-up) environment.
- Strong problem solving abilities and deep commitment to excellence.
- Excellent organizational and communication skills.
- Ability to handle multiple priorities, provide leadership and organization.
- Fluent in French and English
- A full-time permanent position (40h/week) in a growing team.
- 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.