CMC Drug Substance Scientific Writer

Ardena; Oost-Vlaanderen; Hybride; EUR 55 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Group/hospitalization insurance

Flexible working hours

Partial telework

32 days annual leave

Résumé du poste

Ardena in Gent, Belgium, seeks an (Associate) Scientific Writer – CMC Drug Substance to contribute to drug substance process development. You will craft technical documents and support regulatory submissions with cross-team collaboration.

The role offers exposure to cutting-edge chemical and biological development, regulatory guidance, and a dynamic, international work environment with flexible hours.

Qualifications

• Master’s degree or Ph.D. in chemistry or biotechnology.
• Affinity with organic chemistry and drug substance development is a plus.
• Passion for scientific and technical writing for chemical and biopharmaceutical products.
• Strong interest in drug development and regulatory guidelines.
• Fluent in written and spoken English.

Responsabilités

• Write and compile scientific and technical documents for drug substance development.
• Coordinate writing and reviews across CMC activities.
• Ensure alignment with ICH guidelines and up-to-date regulatory standards.
• Manage projects and timelines for technical writing tasks.

Connaissances

Strong scientific writing

Very good communication

Fluent English

Attention to detail

Independent work

Problem solving

AI savviness

Formation

Master’s or PhD in chemistry/biotech

Outils

MS Office (Word, Excel)

Description du poste

Ardena in Gent, Belgium, seeks an (Associate) Scientific Writer – CMC Drug Substance to contribute to drug substance process development. You will craft technical documents and support regulatory submissions with cross-team collaboration.

The role offers exposure to cutting-edge chemical and biological development, regulatory guidance, and a dynamic, international work environment with flexible hours.