Associate Director Agile CMC Lead, US

Job Summary

As the Associate Director Agile CMC Lead, US, you will provide strategic CMC leadership for complex products and lead all aspects of CMC teams operating across the globe. You will develop agile, science-based strategies that support commercialization, lifecycle management, and supply continuity.

Collaborating with Technical Transfer, manufacturing, quality, regulatory, analytical, procurement, and distribution, you will help solve complex CMC challenges and enable effective execution across the global network. You will also coordinate and further a team spanning multiple geographies.

What you'll Do

• Lead Global CMC teams managing sophisticated products through their creation, market introduction, and ongoing management.
• Develop agile CMC strategies that address technical, operational, and supply challenges.
• Lead continued process verification (CPV), validation, alternate raw material, and shipping validation strategies related to drug substance (DS) and final medicinal products.
• Partner with Technical Transfer teams to align CMC strategy with technology transfer, validation, comparability, process performance, and site readiness.
• Work with the Global Logistics Function and supply chain teams to coordinate CMC decisions with logistics, shipping, material flow, and supply needs.
• Bring together development, manufacturing, quality, analytical, logistics, and operations perspectives to overcome advanced CMC obstacles
• Communicate CMC strategies clearly and influence across functions and organizational boundaries.
• Lead and develop a team operating across multiple regions, encouraging collaboration, accountability, inclusion, and strong performance.

Essential Requirements

• Degree in a relevant scientific or engineering discipline.
• Significant CMC leadership experience within the biopharmaceutical industry.
• Experience supporting complex products across development, commercialization, and lifecycle management.
• Experience leading Global CMC teams and working with Product Champions and senior cross-functional partners.
• Strong knowledge of CMC strategy, validation, ongoing process monitoring, comparability, raw material strategy, and supply-related technical considerations.
• Experience across drug substance and drug product operations, including technical transfer, validation, and shipping considerations.
• Experience working across Technical Transfer, manufacturing, analytical, quality, supply chain, and logistics functions.
• People leadership experience, including leading teams across multiple geographies.
• Strong communication and influencing skills, showing proficiency in aligning teams and driving decisions across organizational boundaries.
• Cultural awareness and the ability to work effectively across regions, perspectives, and working styles.