Analytical Services Chemist II — cGMP Lab & Validation

LANNETT COMPANY, INC; Seymour (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

LANNETT COMPANY, INC is seeking a laboratory analyst to perform testing of raw materials, packaging materials, in-process, release and stability samples for pre‑commercial drug products under cGMP guidelines.

Responsibilities include routine and non‑routine tests (HPLC, GC, dissolution, Karl Fischer), method transfer/validation, cleaning validation, thorough documentation, and regulatory compliance in a collaborative team.

Qualifications

• BS Degree in Chemistry or related field with 2–4 years of pharmaceutical analysis in a cGMP lab.
• Experience with analytical methods and lab instrumentation is preferred.
• Familiarity with cGMP, USP/NF and FDA guidelines; strong communication skills.

Responsibilities

• Perform routine and non-routine tests on raw materials, APIs, in-process, and finished products.
• Execute method transfer/validation for assay, dissolution and residual solvents according to ICH/FDA/USP.
• Draft method transfer/validation reports under supervision and document results meticulously.
• Develop and validate analytical Cleaning Validation methods and report findings.
• Maintain notebooks/records, provide progress updates, and ensure regulatory compliance.

Skills

Analytical teamwork

Strong communication

Cross-functional collaboration

Troubleshooting

Education

BS in Chemistry or related field

Tools

HPLC

GC

Dissolution

Karl Fischer

LIMS

CDS

Job description

LANNETT COMPANY, INC is seeking a laboratory analyst to perform testing of raw materials, packaging materials, in-process, release and stability samples for pre‑commercial drug products under cGMP guidelines.

Responsibilities include routine and non‑routine tests (HPLC, GC, dissolution, Karl Fischer), method transfer/validation, cleaning validation, thorough documentation, and regulatory compliance in a collaborative team.