Product Chemist I

Description Job Summary

This position is primarily responsible for the laboratory testing of in-process, release and stability samples for commercial drug products.

• Perform accurate and timely analysis of in-process, release, and stability samples for drug products according to current analytical procedures, SOPs, laboratory guidelines and safety requirements
• Testing performed to include basic lab equipment and procedures, such as pH, Assay by HPLC, and Dissolution
• Document all laboratory testing and maintain accurate and legible notebooks and records
• Peer review of data, reports, and notebooks

• BS Degree in Chemistry or related field
• AS Degree in Chemistry or related field and a minimum of 2 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
• BS Degree in non-science field and a minimum of 4 years of pharmaceutical product analysis experience in a cGMP-regulated lab environment
• Knowledge of cGMP, USP/NF, and FDA guidelines and regulations
• Experience in analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry)
• Excellent oral and written communication skills
• Strong organization and time management skills
• Demonstrated ability to work as part of a cross-functional team
• Working knowledge of Microsoft Word and Excel
• Experience with software associated with a Laboratory Information Management System (LIMS) and a Chromatography Data System (CDS)
• Work mainly performed in lab
• Travel < 5%