Exton, PA (Corporate)
Job Duties: To develop, validate, and transfer analytical methods and analyze pharmaceutical samples. Perform chemical testing following stability protocols and approved methods, and participate in instrument qualification. Perform analytical method transfer, optimization, development, and conducts analytical methods validation of drug substances, drug product, and residual testing, using guidelines from United States Pharmacopeia (USP) and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Author test methods, protocol and reports. Provide analytical testing support for manufacturing process validation, as well astroubleshooting assistance to internal manufacture teams and external clients. Perform routine sample processing and dosage form analysis using HPLC, GC, UV-Vis and other applicable analytical instrumentation. Collate test results and prepare certificates of analysis and stability reports. Comply with all relevant current Good Manufacturing Practices (cGMP) and/or Good Laboratory Practices (GLP) regulatory requirements while carrying out assigned studies.
Requirements: MS degree in Chemistry, Chemical and Biomolecular Engineering, or
relevant scientific discipline; proficiency in operating analytical technologies including Gas Chromatography/Mass Spectroscopy (GC-MS), Fourier Transform Infrared Spectroscopy (FTIR).
To apply: Send CV to HR of Frontage Laboratories, Inc., 700 Pennsylvania Drive, Exton, PA 19341. Ref. JCPA2017