PRODUCT CHEMIST I
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%