Associate Director, Drug Product

Job Summary

As a technical leader for Pulmovant's inhaled dry powder product portfolio, the full-time Associate Director, Drug Product will manage product performance, manufacturability, and the transition toward registration and commercial manufacturing while collaborating with cross-functional teams and external CDMOs in a remote setting.

Key responsibilities

• Serve as a drug product technical leader for formulation and process development, scale-up, and technology transfer through external CDMOs
• Apply Quality by Design (QbD) principles to define Critical Quality Attributes (CQAs) and develop a robust control strategy
• Manage CDMO technical deliverables and support commercial launch activities, including process performance qualification and pre-approval inspection readiness

Required qualifications

• BS, MS, or PhD in pharmaceutical sciences, pharmaceutics, chemical engineering, chemistry, or a related field
• 10+ years of drug product development experience, particularly with inhalation products and late-stage development
• Demonstrated ownership of external CDMO activities and technical deliverables for drug products advancing toward registration
• Hands-on knowledge of inhalation formulation, process scale-up, and regulatory expectations for combination products
• Experience with Module 3 CMC documentation and NDA or MAA preparation for inhaled products preferred