Analytical Services Chemist II: Drug Analysis

Lannett Company; Seymour, Northern (IN, KY); Hybrid; USD 55,000 - 85,000; Full time

Job summary

Lannett Company in Seymour, Indiana, seeks a skilled laboratory analyst to perform testing of raw materials, packaging materials, in-process and finished drug products in a cGMP environment.

The role includes method transfer/validation, analytical method development and cleaning validation, with emphasis on accuracy, documentation and regulatory compliance. You will maintain notebooks, generate reports, and support cross-functional teams in delivering quality pharmaceutical products.

Qualifications

• Experience working in the pharmaceutical industry and/or analytical laboratory preferred
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
• Expertise in analytical methods and lab instrumentation
• Excellent oral and written communication skills
• Strong organization, time management and troubleshooting skills
• Demonstrated ability to work as part of a cross-functional team
• Basic knowledge in Microsoft Word and Excel
• Experience with Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)

Responsibilities

• Perform routine and non-routine physical and chemical tests on raw materials, API, in-process, finished products, and stability samples
• Testing includes pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, HPLC impurities/assay, Dissolution, Residual Solvents by GC, and wet chemistry titrations
• Execute method transfer/validation protocols for basic analytical test methods per ICH/FDA/USP requirements under minimal supervision
• Draft method transfer/validation reports for basic analytical methods under minimal supervision
• Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate reports
• Document all laboratory testing and maintain notebooks and records
• Provide regular progress updates on projects
• Comply with all relevant regulatory requirements
• Maintain professionalism and support team members' self-esteem
• Perform laboratory troubleshooting and implement solutions
• Handle other projects and duties as required

Skills

cGMP knowledge

USP/NF guidelines

FDA guidelines

Analytical methods

HPLC

GC

Dissolution

Wet chemistry

LIMS

CDS

Microsoft Word

Microsoft Excel

Oral and written communication

Teamwork / cross-functional

Troubleshooting

Education

BS in Chemistry or related field

Tools

HPLC instrumentation

GC instrumentation

Dissolution testers

LIMS software

CDS software

Job description

Lannett Company in Seymour, Indiana, seeks a skilled laboratory analyst to perform testing of raw materials, packaging materials, in-process and finished drug products in a cGMP environment.

The role includes method transfer/validation, analytical method development and cleaning validation, with emphasis on accuracy, documentation and regulatory compliance. You will maintain notebooks, generate reports, and support cross-functional teams in delivering quality pharmaceutical products.