Lilly is looking to transform its external manufacturing strategy, operating models, and capabilities to support unprecedented pipeline growth and a wave of new product launches. The Associate Vice President, Drug Products External Manufacturing will be responsible for architecting and driving this transformation, ensuring reliable, high-quality delivery of medicines to patients worldwide through strategic partnerships with CMOs.
Requirements
- Minimum of 15 years of progressive pharmaceutical manufacturing experience.
- Deep expertise in drug product operations, including site leadership and external manufacturing.
- Proven success managing complex manufacturing networks and scaling global supply.
- Technical mastery in design, manufacturing, validation, and quality systems.
- Extensive knowledge of cGMPs, global regulatory standards, and industry best practices.
- Experience with biologics, complex modalities, or combination products.
- Strategic mindset with a bias for execution and continuous improvement.
Responsibilities
- Oversee timely tech transfer and launch readiness for externally manufactured products, scaling with Lilly’s expanding global footprint.
- Implement systems for production scheduling, quality oversight, regulatory compliance, technical agenda execution, and contract lifecycle management.
- Continuously evolve Contract Manufacturing Standards to reflect commercialization dynamics and launch complexity.
- Support business development by evaluating new CMOs and leading transition plans for integration into Lilly’s oversight model.
- Lead quality excellence with CMOs through proactive process monitoring, trending, and deviation management to enable seamless commercialization.
- Apply Lilly’s internal governance rigor to external operations, ensuring parity in process discipline, performance oversight, and accountability.
- Establish and lead CMO governance frameworks, including executive reviews, contract negotiations in partnership with procurement, and strategic relationship management.
Other
- Develop and execute a forward-looking Business and Strategic Plan that accelerates cycle time, elevates quality, and enhances performance across external partnerships.
- Build a high-performing global organization grounded in lean principles, manufacturing excellence, and joint governance with CMOs.
- Attract, develop, and retain exceptional talent across technical, operational, and leadership domains to build a resilient and future-ready organization.
- Demonstrated ability to lead diverse, cross-functional teams with clarity and purpose.
- Strong negotiation and partnership-building skills with internal and external stakeholders.
