Associate Director - LEM Operations

Role Summary

Associate Director - LEM Operations within Lilly's Laboratory for Experimental Medicine (LEM), focusing on project management and operational support to enable planning, preparation, analysis, and reporting of clinical samples. Drives process improvements, automation, and development of new tools; provides consultative support to leadership, scientists, and third-party organizations; aims to optimize insourcing/outsourcing and ensure regulatory compliance.

Responsibilities

• Impact process delivery, automation, and improvement across the division, initially focusing on LEM; drive process improvements for consistent and efficient insourcing and outsourcing.
• Utilize novel business tools to streamline processes, decrease turnaround time, and reduce expenses; lead continuous improvements through tools/apps/automation in validated states.
• Drive tool and resource management to scale support appropriately.
• Provide operational oversight activities in a regulated environment in collaboration with scientists.
• Accountable for data and summary results with TPOs; manage reagents and laboratory supplies; stay current on new TPO technologies; lead issue resolution with TPOs; identify process improvements; apply new processes to data management from TPOs; maintain regulatory compliance by updating procedures per regulatory expectations and audit findings; train new employees on quality expectations, tools, and sponsor oversight documentation; serve as accountable business partner to ensure QA audit findings are closed.

Qualifications

• Master‚Äôs degree in science with at least 10 years of experience, or Bachelor‚Äôs with 12‚Äì15 years of experience.
• Proven leadership and organizational skills; works well in challenging environments.
• Excellent oral and written communication skills; ability to influence and mentor others; strong interpersonal skills; able to gain alignment across views.
• Proven project management, operations, outsourcing, and/or six sigma expertise; ability to lead multiple projects and meet timelines while maintaining compliance.
• Experience in demonstrating process effectiveness and implementing automation-driven process improvements.

Skills

• Process improvement and automation in regulated environments
• Data management and QA collaboration with third-party organizations
• Strategic partnering and stakeholder management
• Budget tracking and forecasting
• Automation tooling and technology adoption

Education

• Master‚Äôs degree in science (preferred) or Bachelor‚Äôs degree with extensive relevant experience

Additional Requirements

• Experience in regulated environments (GLP, GCP, GMP) related to bioanalytical immunogenicity/biomarkers with large molecules
• Experience developing and implementing quality systems for analytical labs
• End-to-end experience in streamlining analytical processes and documentation
• Experience implementing outsourcing strategies and regulatory audit interactions
• Strong budget tracking and forecasting background
• Experience leading automation enhancements and tool development