Analytical Services Chemist II

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