The Analytical Development Scientist II demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. Works on complex problems in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Develop, qualify, validate biological assays with minimum supervision, write SOPs and transfer methods to QC department as needed. Design experiments and write protocols for assay qualification and development. Perform assays or supervise other analysts for assay qualification and validation work. Frequently write technical reports and present findings to internal or external clients. Analyze experimental data with appropriate statistical tools and report scientific results. Interpret data and adhere to strict guidelines on documentation when recording data. Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary.The Analytical Development Scientist II analyzes samples from various sources to provide information on compounds or quantities of compounds present. Use analytical techniques and instrumentation, such as gas and high performance liquid chromatography (HPLC), ion chromatography, electro chromatography and spectroscopy (infrared and ultraviolet amongst others).Use a range of analytical techniques, instrumentation and software. Develop new techniques for the analysis of drug products and chemicals. Work collaboratively in cross-functional teams. Use judgment, creativity and sound technical knowledge to obtain and recommend solutions to problems as directed by AD management. Interact with contract labs in a method development/qualification/validation if necessary. Constantly observe current QC methods and propose areas for improvement. Maintain current knowledge in field of expertise through reading articles and attending technical courses.
A Masters or PhD in a scientific discipline such as Chemistry, Analytical Chemistry, Biochemistry, Biological Sciences, Engineering or equivalent is required. Minimum of three to five years of experience; may include post-doctoral experience for a PhD. Five to ten years related experience for Masters or BS. Expert knowledge of scientific principles and concepts. Extensive experience with chemical/biochemical and biological testing is necessary. The individual should have experience with one or more of the following: HPLC, GC, spectrophotometric assays, immunochemical methods, titration assays, SDS PAGE, IEF, various ELISAs, enzymatic assays and/or IR spectroscopy. The individual should possess good communication skills, be detail-oriented, and able to work well with others. The individual should be flexible and able to handle multiple projects and task, able to solve problems with minimum help. Ascertains relationships between molecular structure and physical properties to aid in analysis of unknown compounds. Conducts research to develop or improve analytical techniques, methodology, procedures and investigates application of instruments in analysis. Organizes and interprets all data obtained. May also require the use of mass spectrometer equipment.