Director Drug Substance

Remote in Switzerland l Full-time l Permanent contract

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 regulatory submissions for global markets including EU, US, and APAC
• Contribute to CMC development plans and filing strategies
• Prepare and evaluate RFPs, technical proposals, timelines, and budgets
• Oversee external manufacturing partners through regular performance and business reviews
• Support annual product reviews and quality reviews
• Collaborate cross functionally with Supply Chain, QA, Regulatory CMC, and Product Teams
• Author development reports and technical documentation
• Support process improvements and implementation of emerging technologies
• Monitor project budgets, financial commitments, and forecasting activities
• Lead and coordinate Drug Substance sub teams and external stakeholders

Requirements

• MSc or PhD in Organic Chemistry or related scientific discipline
• Minimum 10 years of experience within the pharmaceutical or biotech industry
• Strong expertise in small molecule drug substance development across the full product lifecycle
• Proven experience in late stage clinical development, process validation, and commercial manufacturing
• Deep understanding of GMP manufacturing, Quality Risk Management, and Quality by Design principles
• Strong knowledge of global regulatory requirements for drug substance development and submissions
• Experience managing CDMOs and external manufacturing networks