Director Drug Substance

Hybrid, Zugl Full-time Permanent contract

Director Drug Substance

An innovative biotech company is seeking an experienced Drug Substance Lead to oversee and manage drug substance development and manufacturing activities across late stage clinical development, validation, launch, and commercial manufacturing. This role will partner closely with external CDMOs and cross functional internal teams to ensure robust supply, regulatory compliance, and successful lifecycle management of small molecule drug substances.

Responsibilities

• Lead and manage drug substance development and manufacturing activities with external partners and CDMOs
• Define validation strategies and oversee execution for late stage and commercial manufacturing
• Ensure timely clinical and commercial drug substance supply
• Manage technical lifecycle activities related to commercial drug substance manufacturing
• Support regulato...