GMP Analytical Chemist: HPLC Method Support

BioSpace

Lebanon (IN)

On-site

USD 66,000 - 172,000

Full time

18 hours ago
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Benefits offered by this job

401(k) plan
Pension
Vacation benefits
Medical, dental, vision benefits
Flexible benefits
Life insurance
Time off
Well-being benefits

Job summary

Lilly’s Cleaning Validation analytical team in Carmel/Lebanon, IN seeks a chemist with strong HPLC/UPLC skills to perform routine GMP testing and support method development in a first‑of‑its‑kind Medicine Foundry. The role supports Phase 1–3 supply and collaborates with Manufacturing and Quality to ensure safety, quality, and continuous improvement.

Onsite only, with potential for variable shifts to cover shutdowns and peak workloads.

Qualifications

  • Bachelor’s or master’s degree in a relevant STEM field with hands-on experience in a GMP analytical lab.
  • Proficient in HPLC/UPLC with UV detection, sample prep, instrument operation, and data processing.
  • Experience working in a GMP environment with data integrity and good documentation practices.

Responsibilities

  • Perform routine GMP testing of swab and rinse samples using HPLC/UPLC with UV detection to support timely equipment release.
  • Support development, qualification, and validation of analytical methods for residues across multiple modalities.
  • Execute swab and rinse recovery studies and evaluate method performance (sensitivity, linearity, accuracy, precision, specificity, stability).
  • Operate, maintain, and troubleshoot HPLC/UPLC instrumentation and chromatographic methods.
  • Handle samples and standards safely, including high potency compounds, with appropriate containment and practices.
  • Document work accurately in compliance with cGMP and ALCOA+; write/assist with procedures, protocols, and reports.
  • Perform data review and participate in investigations of out-of-trend or out-of-spec results and deviations.
  • Collaborate with cross-functional teams to prioritize testing against manufacturing schedules.
  • Contribute ideas to reduce cycle times and support instrument qualification and method transfer.
  • Flex hours to meet operational demands, including shutdowns, weekends, and overnights.

Skills

Analytical chemistry
GMP experience
Data review & documentation
Troubleshooting instruments
Communication

Education

BS in Analytical Chemistry
MS in Analytical Chemistry

Tools

HPLC/UPLC with UV
Empower

Job description

Lilly’s Cleaning Validation analytical team in Carmel/Lebanon, IN seeks a chemist with strong HPLC/UPLC skills to perform routine GMP testing and support method development in a first‑of‑its‑kind Medicine Foundry. The role supports Phase 1–3 supply and collaborates with Manufacturing and Quality to ensure safety, quality, and continuous improvement.

Onsite only, with potential for variable shifts to cover shutdowns and peak workloads.

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