VP CMC Technical Operations

Role Overview

As VP CMC Technical Operations, you will provide strategic and operational leadership across all aspects of CMC, from early non-clinical development through to pre-launch. You will oversee vendor partnerships, supply chain operations, and technical development, ensuring that the company's programs meet regulatory standards, timelines, and budgets.

This is a hands-on leadership role that requires deep technical expertise, strong problem-solving capabilities, and the ability to influence and execute at the executive level.

Key Responsibilities

• Lead day-to-day and strategic CMC operations, supporting non-clinical, clinical, and pre-launch programs.
• Oversee vendor and contract management, ensuring GMP compliance, quality standards, cost efficiency, and performance across outsourced services.
• Provide scientific and technical guidance for CMC problem-solving, ensuring regulatory expectations are met.
• Manage technology transfer activities, analytical method development/validation, and process development.
• Direct stability studies, specifications development, and analytical characterisation for drug substance and product.
• Generate high-quality Module 3 CMC documentation to support regulatory submissions.
• Contribute to agency briefing books and regulatory meetings with high scientific rigor.
• Support technical due diligence and evaluate CMC risk across the pipeline.
• Drive continuous improvement in supply chain, technical operations, and productivity.

What we're looking for

• Proven senior-level experience in CMC Technical Operations within biotech or pharmaceutical organisations.
• Strong track record in drug substance/drug product development, technology transfer, analytical development, and GMP operations.
• Hands-on experience managing outsourced services, vendor relationships, and supply chains.
• In-depth understanding of regulatory CMC expectations across global markets.
• Demonstrated leadership in multidisciplinary teams and ability to influence at executive and board levels.
• Strategic thinker with the ability to balance scientific rigor, operational efficiency, and commercial priorities.