Pulmovant · 1 month ago
Director of Drug Product Development, Pulmovant
United States
Full-time
Remote
Director/Executive
15+ years expPulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. They are seeking a Drug Product Lead to help drive the development and manufacturing of a dry powder inhaled treatment for pulmonary hypertension, managing late-stage clinical development activities and ensuring a smooth transition to commercial manufacturing.
Clinical TrialsHealth CareHealth DiagnosticsMedical
Responsibilities
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
Qualification
Required
15+ years of experience in inhalation product development (preferably dry powder inhalation)
Demonstrated success advancing an inhalation product through late-stage development (Phase 2b/3) and into registration
Hands-on experience with formulation, process scale-up, drug-device compatibility, and aerodynamic performance testing (APSD, delivered dose)
Strong working knowledge of cGMPs, ICH guidelines, and regulatory expectations for combination products
Proven track record of managing CDMOs, including oversight of technical deliverables, timelines, and budgets
Familiarity with Module 3 CMC documentation, process validation, and stability data requirements
Strong data analysis and risk assessment skills (e.g., QbD, DoE, FMEA)
Exceptional collaboration and communication skills — ability to influence across functional boundaries and external organizations
Comfort operating in fast-paced, lean, biotech environments with high accountability
Preferred
Experience preparing for or supporting NDA/MAA submissions for inhaled products
Company
Pulmovant
Pulmovant develops investigational therapies for respiratory diseases and shares pipeline and clinical study information.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase