Pulmovant

Director

• Serve as the Drug Product Technical Lead for the inhalation dosage form, accountable for product performance, manufacturability, and lifecycle management.
• Lead Phase 3 process characterization, validation, and registration batch execution at CDMOs.
• Provide scientific oversight of formulation development, device compatibility, and container–closure system.
• Partner with other functional area leads to ensure successful method validation, product specifications, and stability studies to support regulatory filings.
• Partner with Quality, Regulatory, and Supply Chain to ensure GMP compliance and pre-approval inspection (PAI) readiness.
• Represent drug product in CMC team meetings, regulatory submissions (Module 3), and health authority interactions.
• Manage technology transfer when needed, manufacturing documentation, and process validation protocols/reports.
• Collaborate closely with other functional areas (drug substance, analytical development, and QA) to ensure a robust control strategy.
• Provide technical guidance and mentoring to junior staff or matrixed contributors as needed.

Director of Drug Product Development