Remote Associate Director, Drug Substance Development

Pulmovant; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

Pulmovant is seeking a highly strategic Associate Director, Drug Substance (Process Chemistry) to drive late-stage development, scale-up, and commercial manufacturing. This role reports to the Sr. Director of Drug Substance Development and links Phase 3 supply with commercial readiness.

The candidate will lead process design, tech transfer across external CDMOs, and apply QbD principles to ensure robust manufacturing and successful regulatory submissions.

Qualifications

• Ph.D. or MS in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related discipline.
• 8+ years of progressive experience in drug substance development and manufacturing within the pharmaceutical industry, focusing on late-stage development and commercialization.
• Strong background in managing CDMO relationships and outsourcing strategies.
• Demonstrated experience in process development, scale-up, and technical transfer.

Responsibilities

• Design, optimize, and define highly robust, scalable drug substance processes.
• Lead scale-up activities and process validation campaigns with external CDMOs and regulatory alignment.
• Embed Quality by Design (QbD) and Design of Experiments (DoE) to establish CPPs and CQAs for Phase 3 and commercial filing.
• Support authoring and reviewing CMC sections for global regulatory submissions (e.g., NDA Module 3) and respond to agency inquiries.

Skills

Process Chemistry

CDMO Management

QbD Principles

Tech Transfer

Regulatory Knowledge

Education

Ph.D. or MS in relevant field

Tools

ssNMR

XRPD

Spectroscopy

Job description

Pulmovant is seeking a highly strategic Associate Director, Drug Substance (Process Chemistry) to drive late-stage development, scale-up, and commercial manufacturing. This role reports to the Sr. Director of Drug Substance Development and links Phase 3 supply with commercial readiness.

The candidate will lead process design, tech transfer across external CDMOs, and apply QbD principles to ensure robust manufacturing and successful regulatory submissions.