Associate Director – Technical Services​/Manufacturing Science - Bioconjugate​/Drug Product

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, and bioconjugates in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. This is a unique opportunity to be a part of the leadership team for the startup of a manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Associate Director – Technical Services/Manufacturing Science (TS/MS / MSAT) - Bioconjugate/Drug Product Manufacturing

The TS/MS organization, also known externally as MSAT (Manufacturing Science and Technology) provides technical oversight to ensure robust and consistent biology and chemistry throughout all aspects of the manufacturing process. Through cross functional collaboration, TS/MS ensures the quality and safety of our products through process monitoring and knowledge to control, prevent and mitigate variability to deliver a reliable supply of medicine.

• The Associate Director – TS/MS - Bioconjugate/Drug Product Manufacturing, will lead a technical organization to provide oversight of biological and bioconjugate manufacturing processes in collaboration with engineering, IT, operations and quality functions.
• TS/MS is responsible for ensuring manufacturing processes run reliably in state control through process monitoring supported through technical knowledge.
• Support site leadership to build a diverse and capable TS/MS organization with the necessary capability, capacity and culture to operate the facility to the highest standards of excellence.
• Lead, develop and retain a high-performing team, fostering a culture of technical excellence, curiosity, accountability and continuous improvement.
• Provide coaching, mentorship and performance management to direct reports, ensuring individuals are developed to their full potential and the team is structured for long-term success.
• Determine TS/MS staffing and resource needs to support process operations through facility startup to enable successful process qualifications and validations.
• Support the development and implementation of robust control strategies to ensure regulatory compliance and operational excellence through lean principles in a digitally native plant.
• Review and approve documentation including procedures, deviation investigations, technical reports, change controls, qualification and validation protocols and summary reports.
• Support the project team to deliver the facility to the site lead team ready to operate and on schedule.

• BS, MS, or PhD in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline, with 5+ years of experience in the biopharmaceutical industry
• Minimum of 3+ years in a people leadership role
• Experience in GMP manufacturing operations and supporting regulatory inspections and audits
• Experience in biological drug product manufacturing, with deep expertise in lyophilization process development and optimization

• Advanced degree (MS or PhD) in biology, biochemistry, chemistry, chemical engineering, or a related scientific discipline preferred
• Knowledge of manufacturing processes, lab scale models, and unit operations used in the manufacturing of biotech products
• Knowledge of laboratory scale models and commercial scale biotech manufacturing processes
• Strong written and verbal communication…