GMP Chemist: HPLC/UPLC Method Dev & Validation

Lilly; Lebanon (IN); On-site; USD 66,000 - 172,000; Full time

Benefits offered by this job

401(k)

Pension

Medical, dental, vision benefits

Well-being benefits

Job summary

Lilly in Carmel, Indiana (with permanent placement in Lebanon) seeks a analytical chemist to support Cleaning Validation and GMP testing in a first-of-its-kind Medicines Foundry. You will perform routine HPLC/UPLC testing, help develop and validate analytical methods, and ensure data integrity in a fast-paced manufacturing environment.

The role is onsite, with flexibility for shift coverage, and offers opportunities to work with multiple modalities and cross-functional teams to enable safe,

Qualifications

• Hands-on experience with HPLC/UPLC and UV detection in a GMP setting.
• Experience with data integrity, e.g., ALCOA+, and documentation practices.
• Ability to develop, qualify, and validate analytical methods across modalities.

Responsibilities

• Perform routine GMP testing of swab and rinse samples using HPLC/UPLC with UV detection.
• Support method development, qualification, and validation for multiple modalities.
• Execute recovery studies and evaluate method performance (sensitivity, accuracy, precision).
• Operate, maintain, and troubleshoot HPLC/UPLC instrumentation and data review.
• Document work accurately in compliance with cGMP and write analytical procedures.
• Collaborate with cross-functional teams to prioritize testing against schedules.
• Participate in investigations of out-of-specification results and deviations.
• Support instrument qualification and method transfer, including contingency planning.

Skills

HPLC/UPLC operation

GMP laboratory practices

Data integrity ALCOA+

Empower CDS

LC-MS (pref)

Sample preparation & analysis

Education

BS in Analytical Chemistry or related STEM field

MS in Analytical Chemistry or related STEM field

Tools

Empower

HPLC/UPLC instrumentation

UV detection

LC-MS

Job description

Lilly in Carmel, Indiana (with permanent placement in Lebanon) seeks a analytical chemist to support Cleaning Validation and GMP testing in a first-of-its-kind Medicines Foundry. You will perform routine HPLC/UPLC testing, help develop and validate analytical methods, and ensure data integrity in a fast-paced manufacturing environment.

The role is onsite, with flexibility for shift coverage, and offers opportunities to work with multiple modalities and cross-functional teams to enable safe,