Director - Operations GMP Laboratories Lilly Medicine Foundry
Scorpion Therapeutics, Lebanon, Indiana, United States, 46052
Role Summary
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. Responsibilities
Lead QC laboratory operations, capability buildout, and maintain continuous inspection readiness. Drive lab design, commissioning, workflow optimization, and implementation of 5S systems. Own GMP compliance, quality systems, and data integrity standards across all analytical operations. Build and develop high-performing teams; lead hiring, onboarding, training, mentorship, and performance management. Foster a culture of safety, quality, and continuous improvement. Oversee instrumentation selection, URS development, and full lifecycle management (IQ/OQ/PQ, PM, calibration, troubleshooting, decommissioning). Ensure compliance with CQV/CSV and change control processes. 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. Establish and maintain a strong safety and quality culture; lead HSE initiatives and hazard mitigation. Ensure compliance with regulatory requirements, SOPs, GDP, and method standards. Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy. Qualifications
Required:
Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline. Required:
Ph.D. with 5+ years or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles. Required:
Extensive experience with CQV/CSV, quality systems, and regulatory compliance. Required:
Strong strategic thinking, influence, and stakeholder management skills. Required:
Proficiency in digital QC systems (LIMS, QMS, Empower, SAP, ELN) and continuous improvement methodologies. Preferred:
Experience with product development, including technical transfer of analytical methods into manufacturing operations. Preferred:
Demonstrated ability to drive and accept change. Preferred:
Good interpersonal skills and a sustained tendency for collaboration. Preferred:
Demonstrated success in persuasion, influence, and negotiation. Preferred:
Ability to prioritize multiple activities and manage ambiguity. Education
Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline. Skills
Strategic leadership and stakeholder management Analytical thinking and commitment to data integrity Proficiency with digital QC systems (LIMS, QMS, Empower, SAP, ELN) Continuous improvement mindset Strong interpersonal and cross-functional collaboration Additional Requirements
Initial location at Lilly Technology Center, Indianapolis; permanent location at the Lilly Medicine Foundry, Lebanon, Indiana. Flexibility to work from Indianapolis or other Lilly sites through 2026–2027. On-site presence required: 8-hour days, five days per week, with occasional shifts during shutdowns and weekends. 0–10% travel required.
#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. Responsibilities
Lead QC laboratory operations, capability buildout, and maintain continuous inspection readiness. Drive lab design, commissioning, workflow optimization, and implementation of 5S systems. Own GMP compliance, quality systems, and data integrity standards across all analytical operations. Build and develop high-performing teams; lead hiring, onboarding, training, mentorship, and performance management. Foster a culture of safety, quality, and continuous improvement. Oversee instrumentation selection, URS development, and full lifecycle management (IQ/OQ/PQ, PM, calibration, troubleshooting, decommissioning). Ensure compliance with CQV/CSV and change control processes. 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. Establish and maintain a strong safety and quality culture; lead HSE initiatives and hazard mitigation. Ensure compliance with regulatory requirements, SOPs, GDP, and method standards. Partner with QA, Manufacturing, Engineering, Global QC, and R&D to support analytical technology transfer and method strategy. Qualifications
Required:
Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline. Required:
Ph.D. with 5+ years or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles. Required:
Extensive experience with CQV/CSV, quality systems, and regulatory compliance. Required:
Strong strategic thinking, influence, and stakeholder management skills. Required:
Proficiency in digital QC systems (LIMS, QMS, Empower, SAP, ELN) and continuous improvement methodologies. Preferred:
Experience with product development, including technical transfer of analytical methods into manufacturing operations. Preferred:
Demonstrated ability to drive and accept change. Preferred:
Good interpersonal skills and a sustained tendency for collaboration. Preferred:
Demonstrated success in persuasion, influence, and negotiation. Preferred:
Ability to prioritize multiple activities and manage ambiguity. Education
Scientific degree (BS/MS/PhD) in Chemistry, Biochemistry, or related discipline. Skills
Strategic leadership and stakeholder management Analytical thinking and commitment to data integrity Proficiency with digital QC systems (LIMS, QMS, Empower, SAP, ELN) Continuous improvement mindset Strong interpersonal and cross-functional collaboration Additional Requirements
Initial location at Lilly Technology Center, Indianapolis; permanent location at the Lilly Medicine Foundry, Lebanon, Indiana. Flexibility to work from Indianapolis or other Lilly sites through 2026–2027. On-site presence required: 8-hour days, five days per week, with occasional shifts during shutdowns and weekends. 0–10% travel required.
#J-18808-Ljbffr