Head of Analytical Development — Inhaled Drug Substance Leader

OpenKrill; United States; Remote; USD 250,000 - 350,000; Full time

Job summary

Pulmovant is seeking a highly experienced Head of Analytical Development to lead the analytical function across drug substance and inhaled drug product. This role reports to the Executive Director, Pharmaceutical Development and will shape specifications, bridging drug substance changes to product performance and stability.

The ideal candidate has 15+ years in pharma analytical development with 8+ years in leadership, deep solid-state and particle characterization expertise, and a track record

Qualifications

• PhD-level degree with 15+ years in analytical development in pharma.
• 8+ years leading analytical chemistry teams for drug substance and inhaled products.
• Experience authoring CTD Module 3 sections and NDA/MAA submissions.
• Strong knowledge of ICH, FDA, EMA guidelines.
• Experience managing multiple CDMOs and external labs.

Responsibilities

• Lead analytical development for drug substance and inhaled product.
• Own the integrated analytical control strategy and specs.
• Oversee method development, validation, transfer, and lifecycle.
• Prepare analytical sections for regulatory submissions and inspections.
• Collaborate across QA, regulatory, and CDMOs; ensure data integrity.

Skills

Analytical development leadership

Solid-state characterization

Particle characterization

Inhalation drug product expertise

Regulatory submissions experience

CDMO management

Education

PhD in Analytical Chemistry / Pharmaceutical Sciences

MS with significant 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 the analytical function across drug substance and inhaled drug product. This role reports to the Executive Director, Pharmaceutical Development and will shape specifications, bridging drug substance changes to product performance and stability.

The ideal candidate has 15+ years in pharma analytical development with 8+ years in leadership, deep solid-state and particle characterization expertise, and a track record