Director of Drug Product Development

Director Of Drug Product Development

Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant's first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.

As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need.

Pulmovant is seeking a Drug Product Lead to help drive the development, scale-up of Phase 3 and commercial manufacturing of our dry powder inhaled small-molecule inhalation program through external CDMOs. This role focuses on managing late-stage clinical development activities (Phase 2 / 3) and ensuring a smooth transition to commercial manufacturing.

The successful candidate will lead cross-functional teams involving drug substance, clinical, non-clinical, quality and regulatory partners, and work closely with external partners to ensure timely delivery of high-quality drug product in compliance with global regulatory standards.

The ideal candidate will be detail driven and have a deep understanding of inhalation drug product process development, technical transfer, regulatory requirements, CDMO management and a proven track record in managing and driving project success.

Key Duties and 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 containerclosure 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.

Education and Experience

Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!