BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Research Associate to work for a leading San Diego biotechnology company.
Description: Support analytical activities by performing analytical testing. Perform sampling, testing, calibration and qualification operations.
Essential Duties and Responsibilities:
Sampling and analysis of raw materials, in-process samples, intermediates, drug substances and drug products;
Analysis of samples related to cleaning verification, reference standards;
Analysis of samples related to performance qualification and monitoring of critical utilities;
Calibration and maintenance of instruments;
Trending test results and investigating out of specification test results;
Good record keeping, writing standard operating procedures and reports.
Education: BS or MS in Chemistry or relevant discipline
Experience: 5+ years of increasing responsibility and applicable experience in a pharmaceutical/biotechnology environment; excellent knowledge of lab operations and regulatory requirements are required, as are proficiency in analytical and technical skills; strong oral and written communication skills; ability to work both independently and as part of a team.
Specific Skills: Demonstrated experience with lab instrumentation, including HPLC, GC, Dissolution, Karl Fischer, IR spectrophotometry, TOC, conductivity, and wet chemistry tests; Familiarity with cleaning verification, stability studies, reference standard program is an asset; Formal cGMP training including knowledge of FDA and ICH guidelines.