Senior Chemist — GMP Method Development & Testing

BioSpace

Lebanon (IN)

On-site

USD 66,000 - 172,000

Full time

26 hours ago
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Benefits offered by this job

401(k)
Pension
Vacation benefits
Flexible benefits
Well-being benefits

Job summary

Lilly in Indiana is seeking a senior analytical chemist to rapidly develop, validate, and routinely run HPLC/UPLC methods (UV, CAD, ELSD) with MS support in a GMP environment for cleaning validation across small molecules, biomolecules, peptides, oligonucleotides, and HP compounds.

The role combines method development with routine GMP testing on-site at the Lilly Medicines Foundry, driving transfer to QC labs and collaboration across Manufacturing, Quality, and Process Development.

Qualifications

  • MS in Analytical Chemistry with 5+ years in pharma
  • BS in Analytical Chemistry with 8+ years in pharma
  • Hands-on HPLC/UPLC with UV, CAD or ELSD
  • LC-MS for method development or sample analysis
  • GMP lab testing, method development/qualification/validation
  • Knowledge of cGMP and data integrity
  • Authorized to work in the United States full-time

Responsibilities

  • Design, develop, and implement analytical methods for cleaning validation across multiple modalities
  • Develop HPLC/UPLC methods with UV, CAD, ELSD and other detectors
  • Apply LC-MS for trace-level residues and degradants
  • Perform routine GMP swab and rinse testing to support equipment release
  • Establish method sensitivity, linearity, accuracy, precision and stability
  • Handle high potency compounds with containment practices
  • Write and validate protocols/reports; support investigations and audits
  • Collaborate with manufacturing, quality, and process development
  • Lead technology transfer to Foundry QC labs and external partners
  • Troubleshoot chromatographic and MS methods; lead investigations
  • Introduce platform methods and streamlined workflows to accelerate development
  • Mentor junior analysts and manage testing priorities
  • Flexible hours to support operations including shutdowns and weekends

Skills

HPLC methods
UPLC methods
LC-MS
GMP testing
cGMP
Data integrity
ALCOA+

Education

MS in Analytical Chemistry
BS in Analytical Chemistry

Tools

Empower

Job description

Lilly in Indiana is seeking a senior analytical chemist to rapidly develop, validate, and routinely run HPLC/UPLC methods (UV, CAD, ELSD) with MS support in a GMP environment for cleaning validation across small molecules, biomolecules, peptides, oligonucleotides, and HP compounds.

The role combines method development with routine GMP testing on-site at the Lilly Medicines Foundry, driving transfer to QC labs and collaboration across Manufacturing, Quality, and Process Development.

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