Associate Director – QC – IAPI Analytical Sciences

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.

The Indianapolis API site has a long legacy of operating with technical excellence while producing lifesaving medicines for many decades. We are currently executing a complex modernization and transformation effort across the site that includes a strong analytical agenda. We are seeking a talented individual that can provide technical leadership and mentoring to drive analytical initiatives and improvements. The Quality Control (QC) Associate Director (AD) Analytical Sciences is responsible for leading the Indianapolis API QC Analytical Sciences team by establishing key capabilities needed to support site operations, QC, and commercialization work within IAPI.

The Analytical Sciences team provides stewardship of the analytical control strategy. The position also influences the analytical control strategy from late stage development to commercialization. This role requires cross-functional collaboration with TS/MS and PAT to support site and network initiatives.

• Uphold company values of Integrity, Excellence, and Respect for People.
• Ensure employees maintain required training and adhere to company policies and guidelines.
• Recruit and manage team members’ performance.
• Develop and execute a comprehensive technical capability strategy to ensure site competencies in fields including but not limited to analytical stewardship, chromatography, Mass Spectroscopy, and Process Analytical Technology.
• Provide leadership and oversight for method development and transfers.
• Drive improvement of the analytical control strategy, continuous optimization of methods leveraged in the laboratory, and continued modernization of equipment and processes used within the laboratory.
• Identify and support the implementation of new technologies/methods that offer significant advantages in cost reduction, compliance improvement or process control.
• Prioritize analytical initiatives based on business impact and risk analysis.
• Provide resources and oversight to ensure the analytical control strategy from raw materials through drug substance is technically sound, cost effective, compliant and sustainable for specific molecules.
• Provide resources and oversight for the troubleshooting and investigation of major analytical issues.
• Collaborate with site operations and TS/MS to develop innovative analytical solutions that drive process efficiency and product quality.
• Support global Analytical Quality Control Organization initiatives as applicable.
• Review and/or approve documents as required.
• Support regulatory inspections and ensure inspection readiness.
• Develop and implement technical coaching and mentoring strategy.

• Bachelor’s degree in a science field related to the laboratory (e.g., chemistry, microbiology or biology)
• 5 years of relevant experience in a cGMP lab.
• 2+ years supervisory experience
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT,…