Associate Director, Drug Product (Fully Remote)

Pulmovant; United States; A distancia; USD 210.000 - 270.000; Jornada completa

Descripción de la vacante

Pulmovant, a Roivant-backed clinical-stage biotechnology company, is seeking a Technical leader for its inhaled dry powder product portfolio. The role focuses on owning product performance, manufacturability, and the transition toward registration and commercial manufacturing.

The candidate will partner with CDMOs, analyze performance data with JMP, and author Module 3 CMC content while addressing agency inquiries as part of a late-stage program striving for Phase 3 development.

Formación

• BS/MS/PhD in pharmaceutical sciences, chemical engineering, or related field.
• 10+ years drug product development experience, including inhalation products.
• Demonstrated ownership of external CDMO activities and technical deliverables for late-stage programs.

Responsabilidades

• Partner with CDMOs on formulation, scale-up, process characterization, and validation.
• Compile and analyze product performance data using statistical tools like JMP.
• Author Module 3 CMC content and respond to agency inquiries.

Conocimientos

Statistical analysis

Cross-functional collaboration

Educación

BS/MS/PhD in pharmaceutical sciences or chemical engineering

Herramientas

JMP

Descripción del empleo

• Technical leader for Pulmovant's inhaled dry powder product portfolio.
• Own product performance, manufacturability, and the transition toward registration and commercial manufacturing.

Key Responsibilities:

• Partner with CDMOs on formulation, scale-up, process characterization, and validation.
• Compile and analyze product performance data using statistical tools like JMP.
• Author Module 3 CMC content and respond to agency inquiries.

Qualifications:

• BS/MS/PhD in pharmaceutical sciences, chemical engineering, or related field.
• 10+ years drug product development experience, including inhalation products.
• Demonstrated ownership of external CDMO activities and technical deliverables for late-stage programs.

Pulmovant is a Roivant-backed clinical-stage biotechnology company focused on developing inhaled therapies for pulmonary diseases. It operates as a lean, collaborative team within the Roivant family, advancing a first-in-class candidate for PH-ILD through Phase 3 development.