Responsibilities/tasks
CMC & technical oversight
* Track and coordinate CMC activities related to Drug Substance and Drug Product manufacturing.
* Interface with and monitor external vendors (CROs, CMOs), ensuring deliverables meet quality and timeline expectations.
* Support analytical method qualification and validation activities.
* Perform critical review of analytical and CMC documentation.
* Contribute to vendor selection and performance evaluation.
Regulatory & Documentation
* Draft, review and maintain CMC documentation.
* Contribute to CMC sections of regulatory submissions (IMPD, IND).
* Support preparation and follow-up of stability protocols and reports.
Project Management & Coordination
* Monitor subcontractor tasks, deliverables, and associated budgets.
* Prepare structured progress updates for internal teams.
* Ensure proper documentation management and archiving in compliance with GxP requirements.
Profile & competencies
* Minimum 1-2 years of experience in CMC development, pharmaceutical development, or biotech project management.
* Experience in working with biologics and/or complex CMC programs is a strong asset.
* Familiarity with analytical method validation (ICH Q2/Q14) is advantageous.
* Knowledge of GMP and general GxP expectations.
* Strong organizational skills with the ability to prioritize in a dynamic environment.
* Comfortable operating in a fast-growing biotech company with challenging timelines.
* Analytical mindset, proactive problem-solving approach, and strong ownership.
* Excellent communication skills.
* Fluent in French and excellent command of English (written and spoken).