New
Chemist
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![]() United States, California, Irvine | |
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Job Title: Chemist Duration: 12 months Location/Site: Irvine, CA, 100% Onsite Description: What are the top 3-5 skills, experience or education required for this position: 1. Analytical techniques such as GC/HPLC/UPLC with various detectors such as CAD, RI, UV/PDA, GC-FID, particle size distribution, physical appearance, pH meter, turbidimeter, osmometer, viscosity, and rheometry. 2. Maintain current knowledge and understanding of GMP requirements and practices 3. Documentation of experiments, results and conclusions. 4. Compiles, evaluates, statistically analyzes, and present technical data. 5. M.S. in Analytical Chemistry or related discipline with minimum 2 years of experience or B.S. in Analytical Chemistry or related discipline with minimum 5 years of experience in analysis of pharmaceutical products or pharmaceutical method development and validation. The ideal candidate is expected to maintain current knowledge and understanding of GMP requirements and practices, familiar with analytical techniques such as HPLC/UPLC with various detectors such as CAD, RI, UV/PDA, GC-FID, particle size distribution, physical appearance, pH meter, turbidimeter, osmometer, viscosity, rheometry and drug delivery system release profiles for drug products and/or drug substances. Upon assignment, independently plans and conducts analytical chemistry analyses in a timely and efficient manner and ensures data integrity and accuracy. Prompt and accurate documentation of experiments, results and conclusions are important responsibilities. Ensures laboratory operational capability by proper maintenance of laboratory equipment and instrumentation. Obtain necessary chemical reagents, reference standards and other components from appropriate sources. The candidate must have proactive, cross functional communication skills. Participate, collaborate and contribute at group and project meetings as required. Provides training to peers to enhance their work effectiveness in generating analytical data. The candidate independently compiles, evaluates, and/or statistically analyzes technical data. With limited supervisor input, design, plan, and perform a variety of project-oriented analytical work assignments (e.g., maintain the integrity of the stability testing program and respective stability data, analyze samples, perform method qualification/ validation, and analyze/record/report results and conclusions of experiments). Additionally, the candidate must be proactive in critically interpreting data and learning new techniques. Under supervision, develop analytical methods and prepare method documents, prepare stability protocols/ reports, prepare method validation protocols/ reports, draft technical memos/reports and support regulatory submissions. A working knowledge of phase appropriate analytical development (methods, validation, and stability program) is preferred. The candidate must conduct their work activities in compliance with all company internal requirements and with applicable regulatory requirements. Company internal requirements include compliance with ethics, environmental health and safety, financial, human resources and general business policies, requirements, and objectives. Minimum Requirements for Education and Experience: -Strong technical writing and communication skills. Must be proficient using Word, Excel, and statistical programs for analytical data evaluation. Ability to review and understand new and innovative analytical methods and provide critical feedback. In addition, the following career elements are required. -M.S. in Analytical Chemistry or related discipline with minimum 2 years of experience or B.S. in Analytical Chemistry or related discipline with minimum 5 years of experience in analysis of pharmaceutical products or pharmaceutical method development and validation. -Minimum 2 years of experience in the analysis of data and writing of technical protocols, reports, and submission ready documents. |