Director of Drug Product Development
Pulmovant
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- 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.
Requirements
- 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.
- Experience preparing for or supporting NDA/MAA submissions for inhaled products preferred.
- 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.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development
- Paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
inhalation product developmentformulation developmentprocess scale-updrug-device compatibilityaerodynamic performance testingcGMPICH guidelinesModule 3 CMC documentationprocess validationstability data requirements
Soft skills
collaborationcommunicationinfluencementoringdata analysisrisk assessmentproblem-solvingleadershipaccountabilityadaptability