Analytical Services Chemist II

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

Description

Summary

This position is primarily responsible for the laboratory testing of raw materials, packaging materials, in-process, release and stability samples for pre-commercial drug products, including the evaluation of new raw materials, new packaging materials, reference standard qualifications, method transfers, and method validations within the framework of cGMP compliance guidelines.

Responsibilities

• Perform routine and non-routine physical and chemical tests and assays on raw materials, API's, in-process, finished products, experimental batches and associated stability studies
• Testing performed to include basic and complex lab equipment and procedures, such as pH, Loss on Drying, Residue on Ignition, Water Content by Karl Fischer, Assay/Impurities by HPLC, Dissolution, Residual Solvents by GC, and wet chemistry techniques such as titrations and sample derivatizations
• Execute method transfer/validation protocols for basic analytical test methods for drug substance/product assay/dissolution/ residual solvents according to ICH/FDA/USP requirements under minimal supervision
• Draft method transfer/validation reports for basic analytical test methods for drug substance/product assay/dissolution according to ICH/FDA/USP requirements under minimal supervision
• Develop and validate analytical Cleaning Validation methods and perform testing of cleaning validation samples and generate analytical report with supervision.
• Document all laboratory testing and maintain accurate and legible notebooks and records
• Provide regular update progress reports of projects
• Comply with all relevant regulatory requirements
• At all times strive to maintain the self-esteem of individual team members and the professionalism of the group as a whole
• Perform laboratory troubleshooting, propose solutions and implement
• Other projects and duties as required or assigned

Experience

• BS Degree in Chemistry or related field and 2 - 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment

Requirements

Skills

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