The Analytical Development Senior Scientist 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 Bioassays with minimum supervision, write SOPs and transfer methods to QC department as needed. Familiar with regulatory guidelines pertaining to assay development/qualification/validation and BSL-2 laboratories and working in BSL-2 environment. Design experiments and write protocols for assay development and validation. Perform assays or supervise other analysts for assay development 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.
The Analytical Development Senior Scientist interprets data and adheres to strict guidelines on documentation when recording data. Review and/or approve cGMP documentation generated by other analysts in the laboratory if necessary. Analyze samples from various sources to provide information on compounds or quantities of compounds present. Use of mammalian cell culture techniques. Use analytical technique, software,, and instrumentation, such as HPLC, GC, spectrophotometric assays, immunochemical methods, titration assays, SDS PAGE, IEF, ELISAs, enzymatic assays and/or IR spectroscopy. 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 method development/qualification/validation. Maintain an overview of 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. A minimum of five years of industrial experience Expert knowledge of scientific principles and concepts. Knowledge of working in a BSL-2 environment. Extensive experience with chemical/biochemical and biological testing is necessary. The individual should have experience with one or more of the following: mammalian cell culture techniques, Bioassay development, neutralization assays, method transfer, Bioassay development and validation. The individual should have experience in working under BSL-2 conditions and should be familiar with required guidelines and procedures. Good communication skills with ability to multitask. Organizes and interprets all data obtained.