CMC Consultant/ Junior Project Manager (Part-Time – ...

We are seeking a part-time CMC Consultant / Junior Project Manager to support the execution and coordination of development activities within a fast-growing biotech environment.

This position combines scientific oversight and operational project coordination, with direct exposure to Drug Substance (DS) and Drug Product (DP) development, analytical method validation, and regulatory CMC documentation.

The consultant will work closely with internal stakeholders and external partners (CROs, CMOs) to ensure timely, compliant and high-quality advancement of development programs in a GMP-aligned setting.

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.

Qualifications

• 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.
• Fluent in French and excellent command of English (written and spoken).