Do you dare to shake up the medical world and improve the lives of patients with chronic degenerative diseases?Allegro is a revolutionary start-up that designs and develops ground-breaking biomedical nanotechnology for the treatment of osteoarthritis. We are hiring you as Manufacturing and Process Expert (CMC).AboutThe CMC expert is responsible for developing the manufacturing and control of a medical device. The mission of the CMC expert is to lead the development of products and associated manufacturing and quality control processes during optimization, design transfer and scale-up. This includes raw materials control, formulation and analytical developments for R&D batches but also QC equipment selection to validate the related methods and routine testing throughout the product life cycleEducationMaster’s degree or PhD in Sciences, Engineering or Pharmacy or a related discipline.Additionally, ongoing professional development and training are essential in this rapidly evolving field to stay updated on the latest technologies, methodologies, and regulatory requirements.Experience- Scientific background, or relevant experience in medical products.- Experience of at least 5 years in polymer medical device (or pharmaceutical/biotech) manufacturing, hydrogel knowledge is an absolute plus point.- Industrial scale-up, design of experiments, process validation, batch vs continuous processes.- Proven experience in analytics according to ICH Q2 and ICH Q3.- Proven proficiency in equipment qualification.- Strong Quality Systems Knowledge (cGMP’s and ISO13485)- Proven experience with standard investigational tools.- Proven experience in supplier and subcontractor management.- Experience in quality risk management (ICH Q9, ISO14971).- Data driven, with good statistical competence.- Experience with the Design Control process is a plus.- Experience in internal audit is a plus.- Knowledge of the following techniques: UV-vis spectroscopy, rheology, sterile barrier integrity testing, pH measurements, automatic titration. Knowledge of chromatographic techniques (GC, U/HPLC, MS etc.) is a plus.- Fluent in English and French and/or Dutch.Skills- Manufacturing (medical device / polymers)- Organic Chemistry- Industrial scale-up- Effective communication skills- Problem-solving ability- Results oriented- Rigorous- Pragmatic- Factual/data-based decision making- Open minded and curious- Collaboration and teamwork- Ethical conduct in research- Attention to detail- Critical thinking- Project management skills are a plus.