Drug Product Development Lead

Job Title: Drug Product Development and CMC Leader (Contract – 7 Months)

📅 Start Date: End of July/ Mid-August

🕒 Duration: Until end of March 2026

💼 Workload: Full-time (or minimum 80%)

We are seeking a highly experienced Drug Product Development and CMC Leader to join our team on a contract basis. This is a unique opportunity to contribute to a late-phase small molecule development project currently transitioning from Phase 2 (capsule) to Phase 3 (tablet). You will play a key role in managing outsourced development and clinical bulk supply activities, while shaping the formulation and manufacturing strategy.

🔬 Your Mission

As the Drug Product (DP) Development Leader, you will:

• Lead the DP development and clinical supply strategy for a late-phase project.
• Represent CMC in the project team and align strategy, planning, and execution.
• Manage the CMC budget and oversee the execution of the CMC development plan.
• Supervise manufacturing of development and GMP batches.
• Evaluate formulation/process data and adjust strategies as needed.
• Oversee stability studies and regulatory documentation.
• Manage external service providers (ESPs) and ensure compliance with cGMP.
• Collaborate with internal Quality and Compliance teams.
• Support due diligence activities when required.

🧪 Your Profile

• MSc or PhD in Chemistry, Pharmaceutical Sciences, Bio-Engineering, or equivalent experience.
• Minimum 10 years of experience in drug product development.
• Deep expertise in solid oral formulation development.
• Proven experience working with CROs and in cross-functional teams.
• Strong leadership, communication, and organizational skills.
• Fluent in English (written and spoken).
• Hands-on, pragmatic, and solution-oriented.

If you're a seasoned CMC professional ready to make an impact in a dynamic, late-stage development environment, we’d love to hear from you.

Apply now or reach out for more information!