Director of Drug Product Development at Roivant Sciences

, , United States -

Full Time

Start Date

Immediate

Expiry Date

13 Feb, 26

Salary

0.0

Posted On

15 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Inhalation Product Development, Regulatory Requirements, CDMO Management, Formulation Development, Process Scale-Up, Technical Transfer, Quality Assurance, Data Analysis, Risk Assessment, Collaboration, Communication Skills, Project Management, GMP Compliance, Device Compatibility, Stability Studies, Lifecycle Management

Industry

Biotechnology

Description

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. Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. A phase 2 trial is currently ongoing to further characterize safety and efficacy. 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. For more information, please visit https://www.pulmovant.com. Director/Senior Director, Drug Product Development and Manufacturing Summary: 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. This is an exciting and visible role for a highly qualified and motivated individual. 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 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. Education and Experience 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. 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!

Responsibilities

The successful candidate will lead cross-functional teams to manage late-stage clinical development activities and ensure a smooth transition to commercial manufacturing. They will serve as the Drug Product Technical Lead, accountable for product performance and lifecycle management.