Associate Director – QC – IAPI Analytical Sciences

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and seek individuals determined to make life better for people around the world.

The Indianapolis API site has a long legacy of operating with technical excellence while producing lifesaving medicines. We are executing a modernization and transformation effort across the site with a strong analytical agenda and are seeking a leader to drive analytical initiatives and improvements.

The Quality Control (QC) Associate Director (AD) Analytical Sciences leads the Indianapolis API QC Analytical Sciences team by establishing key capabilities to support site operations, QC, and commercialization. The team provides stewardship of the analytical control strategy and influences the 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 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 and modernization of equipment and processes in the laboratory.
• Identify and implement new technologies/methods that offer advantages in cost, compliance, 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 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
• Demonstrated strong data analysis and documentation skills
• Demonstrated attention to detail, critical decision making, and problem-solving skills
• Demonstrated strong oral and written communication and interpersonal interaction skills
• Knowledge of cGMPs and quality systems

• Experience in method development and validation
• Experience with a broad range of analytical techniques
• Knowledge of ICH guidelines applicable to analytical sciences
• Strong statistical skills

• BS/BA in Chemistry or science-related field, or comparable experience

• On-site presence required

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