CMC Lead (Drug Product)

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.

Practicalities: 

• Start Date: ASAP 
• Duration: until March 2026
• Interview Process: 2 Stages
• Location: Mechelen,

Key Responsibilities:

• Represent CMC in the project team
• Oversee capsule-to-tablet development activities at Patheon
  • Review & finalize outstanding documentation
  • Evaluate and plan further development activities (e.g. scale-up/optimization post rBA GMP campaign)
• Monitor capsule and tablet stability studies and extend shelf life if required
• Archive finalized documents in CAESR
• Respond to Health Authority questions related to the rBA submission
• Support due diligence activities, if requested

Profile Requirements:

• Solid experience in CMC and DP combined (solids formulation expertise is essential)
• Late-stage development exposure
• Strong hands-on attitude and external vendor management
• Experience with cross-functional collaboration
• Workload: Ideally full-time (min. 80%)

Apply to disucss further!