Eli Lilly and Company
Director - Operations GMP Laboratories Lilly Medicine Foundry
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
The Director of Operations for Analytical GMP Laboratories will lead all aspects of GMP analytical operations at the Lilly Medicine Foundry. This role oversees startup, scale-up, and steady-state operations, ensuring laboratory capability, GMP compliance, and digital enablement. The position requires strategic leadership, operational excellence, and a strong quality culture to support manufacturing and regulatory commitments. **Key Responsibilities** ***Operational Excellence**** Manage capacity planning, scheduling, and laboratory inventories.* Oversee sample intake, chain of custody, and timely result release.* Ensure robust deviation management, investigations, and CAPA implementation.***Safety & Compliance**** Establish and maintain a strong safety and quality culture; lead HSE initiatives and hazard mitigation.***Cross-Functional Collaboration**** Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy.**Minimum Qualifications*** Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline.* Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles.* Extensive experience with CQV/CSV, quality systems, and regulatory compliance.* Strong strategic thinking, influence, and stakeholder management skills.* Proficiency in digital QC systems (LIMS, QMS, Empower, SAP, ELN) and continuous improvement methodologies.**Additional Skills and Preferences:*** Experience with product development, including technical transfer of analytical methods into manufacturing operations.* Demonstrated ability to drive and accept change.Ensure compliance with regulatory requirements, SOPs, GDP, and method standards. Good interpersonal skills and a sustained tendency for collaboration. Ability to prioritize multiple activities and manage ambiguity. Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr
The Director of Operations for Analytical GMP Laboratories will lead all aspects of GMP analytical operations at the Lilly Medicine Foundry. This role oversees startup, scale-up, and steady-state operations, ensuring laboratory capability, GMP compliance, and digital enablement. The position requires strategic leadership, operational excellence, and a strong quality culture to support manufacturing and regulatory commitments. **Key Responsibilities** ***Operational Excellence**** Manage capacity planning, scheduling, and laboratory inventories.* Oversee sample intake, chain of custody, and timely result release.* Ensure robust deviation management, investigations, and CAPA implementation.***Safety & Compliance**** Establish and maintain a strong safety and quality culture; lead HSE initiatives and hazard mitigation.***Cross-Functional Collaboration**** Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy.**Minimum Qualifications*** Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline.* Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles.* Extensive experience with CQV/CSV, quality systems, and regulatory compliance.* Strong strategic thinking, influence, and stakeholder management skills.* Proficiency in digital QC systems (LIMS, QMS, Empower, SAP, ELN) and continuous improvement methodologies.**Additional Skills and Preferences:*** Experience with product development, including technical transfer of analytical methods into manufacturing operations.* Demonstrated ability to drive and accept change.Ensure compliance with regulatory requirements, SOPs, GDP, and method standards. Good interpersonal skills and a sustained tendency for collaboration. Ability to prioritize multiple activities and manage ambiguity. Initial location at Lilly Technology Center, Indianapolis.
Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr