Eli Lilly and Company

Advisor – GMP Testing Group

Eli Lilly and Company

full-time

Posted on:

Location Type: Hybrid

Location: Indianapolis • United States

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Salary

💰 $126,000 - $204,600 per year

About the role

  • Provide scientific and technical leadership for GMP analytical testing activities
  • Ensure analytical methods are fit for purpose and aligned with regulatory and lifecycle expectations
  • Lead method readiness activities including method qualification, validation, transfer, troubleshooting, and ongoing lifecycle management
  • Stay current with emerging analytical technologies and implement improvements to enhance efficiency, robustness, and compliance
  • Ensure all laboratory testing operations comply with cGMP, GDP, and internal quality standards
  • Maintain a constant state of inspection readiness; lead or support audits
  • Own and manage quality events (deviations, investigations, CAPAs, change controls)
  • Champion high quality data review and adherence to Good Documentation Practices
  • Lead day to day GMP testing operations
  • Oversee sample management, chain of custody, workflow prioritization
  • Manage instrument and equipment lifecycle
  • Drive continuous optimization of workflows
  • Forecast, plan, and allocate personnel, equipment
  • Manage laboratory inventory and ensure uninterrupted availability of critical materials
  • Lead, coach, and develop a team of analysts and scientists
  • Implement cross training to broaden team capability
  • Drive deployment of new instruments, digital tools, and advanced analytical technologies

Requirements

  • BS/MS/PhD in Chemistry, Biology, Chemical Engineering, or related scientific discipline
  • Ph.D. with 5+ or BS/MS with 10+ years of experience in GMP analytical laboratories with progressive leadership roles
  • Experience leading GMP analytical testing teams
  • Demonstrated skill in managing investigations, deviations, CAPAs, and regulatory interactions
  • Strong technical understanding of analytical method lifecycle requirements under GMP.
Benefits
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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMP analytical testingmethod qualificationmethod validationmethod transfertroubleshootingGood Documentation Practicesdata reviewanalytical method lifecycleworkflow optimizationsample management
Soft Skills
leadershipcoachingteam developmentcommunicationproblem-solvingorganizational skillscross trainingaudit supportpersonnel managementquality management