Director of Commercial Manufacturing Operations - Remote

Overview

We are seeking a seasoned pharmaceutical leader to guide commercial manufacturing operations and CMC development across all stages of drug substance (DS) and drug product (DP) supply.

In Short

• Oversee end-to-end commercial manufacturing activities.
• Ensure GMP compliance and regulatory readiness.
• Drive CMC strategy from late-phase development through commercialization.
• Manage relationships with CDMOs and raw material suppliers.
• Build and mentor a high-performing team of CMC professionals.
• Apply scientific knowledge to resolve technical challenges.
• Guide process scale-up and technology transfers.
• Collaborate with cross-functional teams.
• Negotiate contracts and oversee quality and timelines.
• Lead CMC-related sections for regulatory submissions.

Requirements

• 15+ years in the pharmaceutical industry.
• Deep understanding of API and DP manufacturing.
• Demonstrated ability to lead multidisciplinary teams.
• Direct experience with global regulatory filings.
• Advanced degree in Chemistry or related field preferred.

Benefits

• Patient Days to hear from individuals living with conditions.
• A culture inspired by values of patient-first and transparency.
• Access to learning and development resources.
• Robust compensation and benefits package.
• Flexible PTO and rapid career advancement.