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.

Responsibilities

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 Education/Qualifications: 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%