About the Role

As Drug Product Development (DP) Leader within the CMC team, you will provide drug product development expertise for the further development of the project. You will manage the clinical bulk supply for a late-stage small molecule program (currently Phase 2 – capsule; Phase 3 tablet development in progress). The development and manufacturing activities are outsourced to external service providers (ESPs). In this key role, you will contribute your deep pharmaceutical expertise—especially in solid dosage form development—to drive the success of the project.

Key Responsibilities

• Lead the development and supply of drug product materials in line with the overall CMC and clinical strategy
• Develop CMC strategy
• Represent CMC within the project team
• Align on strategy, planning, activities and ensure effective coordination of CMC team
• Manage the CMC budget and report updates to the project team
• Oversee the (bulk) manufacturing of development batches and GMP batches for clinical purposes
• Analyze formulation and process data, and adapt as needed
• Monitor capsule and tablet stability studies, refining plans based on findings
• Prepare, review, and approve CMC documentation for regulatory submissions
• Manage and liaise with ESPs performing development and manufacturing tasks
• Review and archive key documentation from ESPs (e.g., protocols, batch records, reports)
• Collaborate with Quality & Compliance teams to ensure ESPs adhere to cGMP standards
• Keep the Product Specification File up to date
• Ensure compliance with internal procedures and procedures and complete mandatory trainings
• Provide input for due diligence processes when requested

• Master or PhD in pharmaceutical sciences, chemistry, bio-engineering, or equivalent through experience
• Minimum of 10 years of relevant experience in a drug product development role
• Expertise in solid formulation development and experience working with CROs
• Proven track record in cross-functional collaboration and technical leadership
• Fluent in English, both written and spoken
• Strong organizational, interpersonal, and communication skills
• Pragmatic, hands-on, and solution-oriented