Manufacturing and Process Expert (CMC)

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).

About

The 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 cycle

Education

Master'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.