Head of Analytical Development for Inhaled Therapies

Pulmovant; United States; Remote; USD 200,000 - 300,000; Full time

Job summary

Pulmovant is seeking a highly experienced Head of Analytical Development to lead analytical strategy across drug substance and dry powder inhaler product lines. You will guide method development, validation, and lifecycle management, and partner with QA, regulatory, and CDMOs to ensure NDA readiness and product quality.

The role requires senior leadership and deep technical expertise. The ideal candidate has a PhD (or equivalent) with 15+ years in pharma analytics and 8+ years leading teams

Qualifications

• PhD or MS with 15+ years in analytical development in pharma.
• 8+ years leading analytical chemistry across drug substance and inhaled product.
• Experience authoring CTD Module 3 sections for NDA/MAA submissions.
• Deep expertise in solid-state and particle characterization techniques.

Responsibilities

• Lead analytical development for drug substance and inhaled drug product.
• Own integrated analytical control strategy and specifications.
• Oversee method development, validation, transfer, and lifecycle management.
• Support regulatory submissions and inspections with analytical input.
• Manage CDMOs and external partners; align with program goals.

Skills

Solid-state characterization

Particle characterization

Inhaled drug products

CTD Module 3 authoring

Regulatory collaboration

Cross-functional leadership

Education

PhD in Analytical Chemistry or related

MS with extensive relevant experience

Tools

XRPD

DSC/TGA

Raman/IR

SEM

Laser diffraction

Job description

Pulmovant is seeking a highly experienced Head of Analytical Development to lead analytical strategy across drug substance and dry powder inhaler product lines. You will guide method development, validation, and lifecycle management, and partner with QA, regulatory, and CDMOs to ensure NDA readiness and product quality.

The role requires senior leadership and deep technical expertise. The ideal candidate has a PhD (or equivalent) with 15+ years in pharma analytics and 8+ years leading teams