Job Description

Job Description

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

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)

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