Associate Director, Drug Substance (Process Chemistry) (Fully Remote)

Pulmovant; United States; Remote; USD 200,000 - 260,000; Full time

Job summary

Pulmovant, a Roivant-backed clinical-stage biotech, is seeking a senior leader to oversee late‑stage drug substance process development and CMC strategy in the United States.

You will drive tech transfer and PPQ activities across CDMOs and apply QbD/DoE principles to ensure GMP compliance and regulatory readiness for a Phase 3 asset such as mosliciguat.

Qualifications

• 8+ years in pharmaceutical drug substance development with an emphasis on R&D and GMP.
• Strong CDMO oversight, regulatory CMC, and QbD/DoE experience.

Responsibilities

• Lead late-stage drug substance development and CMC strategy.
• Manage tech transfer and PPQ activities across CDMOs.

Skills

Drug substance development

R&D experience

GMP expertise

CDMO oversight

Regulatory CMC

QbD/DoE

Job description

• Lead late-stage drug substance process development and CMC strategy.
• Manage tech transfer and PPQ activities across CDMOs.

What We Look For:

• 8+ years in pharmaceutical drug substance development with R&D and GMP expertise.
• Strong CDMO oversight, regulatory CMC, and QbD/DoE experience.

Why Pulmovant:

• Work on a Phase 3 asset with strong clinical data.
• Join a collaborative Roivant-backed biotech culture.

Pulmovant is a Roivant-backed clinical-stage biotech developing inhaled therapies for pulmonary diseases. Its lead candidate, mosliciguat, is in Phase 3 for PH-ILD, and the company operates with a collaborative, fast-paced Roivant culture.