Description: Will perform routine tests of raw materials, in-process, finished product and stability samples including dissolution, assays, chromatographic purity, content uniformity using UV and HPLC, particle size distribution using different tecniques including Light Scattering (e.g. Malvern), density, water determination by KF, and test according to the in-house monographs and USP in a regulated laboratory environment.
Maintain accurate lab notebooks and complete all related analytical reports, write summaries and keep proper documentation in compliance with SOPs. Ensure notebooks are reviewed in a timely manner in accordance with SOPs. Maintain the laboratories utilizing good housekeeping practices and in compliance with cGMP. Analyze and interpret results in written and oral format in consultation with supervisor / laboratory manager. Follow all SOPs and safety guidelines to ensure compliance with cGMP environment and company safety practices.
Qualifications: Chemist III and Senior Chemist are similar positions with similar responsibilities. The determination of levels is based on the candidate's education, experience and ability to handle more complex testing, perform peer notebook review, train and guide less experienced chemists and troubleshoot problems, all with less supervision.
Chemist III Bachelor's degree in Chemistry or related scientific field - Requires 4-6 years related experience in pharmaceutical analysis. Master's degree in Chemistry or related scientific field - Requires 2-4 years related experience in pharmaceutical analysis. Doctorate degree in Chemistry or related scientific field - Requires 0-2 years related experience in pharmaceutical analysis.
Senior Chemist Bachelor's degree in Chemistry or related scientific field - Requires 6+ years related experience in pharmaceutical analysis. Master's degree in Chemistry or related scientific field - Requires 4-6 years related experience in pharmaceuical analysis. Doctorate degree in Chemistry or related scientif field - Requires 2+ years related experience in pharmaceutical analysis.
Both positions require the successful candidate to have: - Ability to deal with problems involving several concrete variables in standardized situations. - Ability to carry out necessary computations and to draw and interpret graphs. - A working knowledge of instrumentation software. - Ability to aid in the writing of laboratory practices and modifications of stndard operating procedures. - Ability to assist in the validation of QC methods. - Ability to lead and direct the work of others. - An expected wide degree of creativity and latitude. - A knowledge of Excel and MS Office Suite word processing software. - Excellent communication skills, including the ability to speak clearly, listen and gain clarification, respond well to questions and write clearly and informatively.