Position: Associate Director, Drug Product
Summary:The Associate Director, Drug Product will serve as a technical leader for Pulmovant's inhaled dry powder product portfolio, with accountability for product performance, manufacturability, and the transition toward registration and commercial manufacturing. The role will partner closely with Drug Substance, Analytical Development, Clinical Supply, Quality, Regulatory Affairs and external CDMOs to deliver drug product and resolve technical risks across the development program.
KeyDuties and Responsibilities - Serve as a drug product technical leader for formulation and process development, scale-up, process characterization, technology transfer, and validation through external CDMOs
- Apply Quality by Design (QbD) principles to define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) and develop a robust control strategy
- Compile, analyze, and trend drug product performance data and stability results using statistical tools such as JMP; summarize findings and recommend process or specification actions
- Manage CDMO technical deliverables and review key technical documentation (master batch records, protocols, and technical reports) for accuracy, completeness, and GMP compliance
- Support commercial launch activities for drug product manufacturing, including process performance qualification (PPQ) planning and execution and pre-approval inspection (PAI) readiness
- Provide scientific oversight of drug product and inhaler compatibility, container closure systems, and aerosol performance
- Represent CMC on cross-functional project teams, maintaining timelines and action items to ensure uninterrupted supply of clinical trial material
- Lead drug product contributions to CMC submissions, including authoring Module 3 content and responding to agency inquiries
- Provide technical guidance to cross-functional team members and external partners
Education and Experience - BS, MS, or PhD in pharmaceutical sciences, pharmaceutics, chemical engineering, chemistry, or a related field
- 10+ years of drug product development experience, including substantial work with inhalation products and late-stage development
- Demonstrated ownership of external CDMO activities and technical deliverables for a drug product advancing toward registration
EssentialSkills andAbilities - Hands-on knowledge of inhalation formulation and process scale-up, drug and device compatibility, and aerodynamic performance testing
- Working knowledge of cGMP, ICH guidelines, process validation, stability requirements, and regulatory expectations for combination products
- Experience with Module 3 CMC documentation and NDA or MAA preparation for an inhaled product preferred
- Ability to analyze data, assess technical risks, and drive decisions across internal functions and external partners
- Comfort taking direct accountability in a lean development organization
