The successful candidate will independently perform analytical testing, method development and method validation to support the clinical trial process of a drug delivery device. Analytical lab experience working with HPLC and/or UPLC is critical.
Independently develop, optimize, tweak and validate analytical methods using the HPLC, UPLC and/or LC-MS
Complete associated technical documentation – protocols, development and validation reports, specifications, etc.
Carry out complex experiments involving a variety of lab skills to achieve project goals
Conduct stability testing using in-process or developed methods
Comply with FDA guidelines and SOPs in a cGMP environment
Performs dissolutions, extractions and other preparatory techniques on samples
Gathers and records data according to SOP and protocol guidelines, and performs technical evaluation of data to analyze, interpret and report on results
Communicates with staff and clients as needed throughout the analytical process to ensure compliance with protocols and SOPs
Maintains and troubleshoots analytical equipment as required
Bachelor's degree in chemistry or a related scientific field
Experience independently developing and validating methods for the HPLC, UPLC and/or LC-MS
Working knowledge of GMP and applicable ISO standards is preferred
Ability to independently troubleshoot instrumentation