Product Chemist I

Job Description

Job Description

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%

Requirements: