CMC Lead - Drug Product

Job Description

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.

Company Description:

We are an innovative biotechnology organization operating across Europe and the U.S., dedicated to developing transformational medicines in immunology and oncology. With an end-to-end model from discovery to patient, we combine cutting-edge science, technology, and collaborative approaches to advance a pipeline of small molecules, biologics, and cell therapies. Our mission is to improve quality of life through meaningful therapeutic breakthroughs.

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:

• Experience responding to regulatory authority questions and contributing to submissions
• Familiarity with document management and archiving systems
• Prior involvement in due diligence and technical transfer
• Understanding of budgeting and strategic project planning within CMC

Additional Insights:

• Location: Mechelen, Belgium
• Start Date: Mid-August to early September 2025
• Duration: Until end of March 2026
• Workload: Ideally full-time (minimum 80%)
• Type: Contractor position