CMC Lead

We are seeking a CMC Leader with Drug Product (DP) Solids Expertise to lead late-phase development activities for a solid oral drug product within a small molecule clinical program. This full-time contractor role is based in Mechelen and will run from early September 2025 to March 2026. The selected candidate will oversee formulation development, manufacturing, and documentation activities, while acting as the CMC representative within the cross-functional project team.

This position requires a senior profile with strong technical expertise in oral solid formulations, vendor oversight, and experience driving late-stage CMC strategy and execution.

Purpose :

Your core purpose will be managing the drug product development and clinical bulk supplies for one late phase small molecule drug development project (currently in Phase 2 - capsule; development for Phase 3 ongoing - tablet), which are outsourced to External Service Providers (ESPs). As an expert member of the CMC group, you will provide drug product development expertise for this development project. Highly qualified in pharmaceutical technology, with an expertise in solid formulation development, you will come up with formulation and production strategies needed to support this late development project.

Essential Requirements :

• MSc or PhD in chemistry, pharmaceutical sciences, bio-engineering, or equivalent experience
• At least 10 years of relevant experience in drug product development
• Expertise in solid oral dosage forms (capsule and tablet)
• Proven track record in late-stage development, including scale-up and optimization
• Strong external vendor oversight experience
• Fluent in English, with excellent communication and collaboration skills
• Confident leading technical discussions and representing CMC in cross-functional settings
• Hands-on, pragmatic approach with strong organizational capabilities

Desirable Requirements :

Additional Insights :