Experience must include 24 months inwith the following GLP Good Laboratory PracticesGMP Good Manufacturing Practices; Analytical Method Development, Validation, and Transfer; Experimental Design, and Equipment IQ Installation Qualification, OQ Operational Qualification, and PQ Performance Qualification; SOP Standard Operating Procedure Authoring and Implementation; Quality Data Review; and Risk Assessment.br br PLEASE NOTE Our business needs dictate that a qualified candidate for the Senior Scientist, Analytical Development role possess the minimum education and experience listed herein. Nutcracker Therapeutics, Inc. is a life sciences technology company developing new technologies for application in life sciences research and product development. This position is not entrylevel but is a senior position, vital and indispensable in developing, maintaining, and growing our operations. The successful candidate will enable us to synthesize a new generation of nucleic acidbased therapeutics. To develop, optimize, and validate in vitro analytical methods to be used for releasestability of intermediates and mRNA messenger Ribonucleic Acidbased therapeutic products, she must have deep and demonstrable understanding of and experience inwith GLPGMP; Analytical Method Development, Validation, and Transfer; SOP Authoring and Implementation; and Quality Data Review. She must apply deep and advanced knowledge and experience of Experimental Design; as well as of Equipment IQ, OQ, and PQ to perform indepth characterization of therapeutic mRNA products, intermediates, impurities, and degradants to build a strong understanding of critical quality attributes. She must use the above advanced knowledge and skills and also apply expertise in Risk Assessment to actively engage with internal and crossfunctional stake holders to design analytical methods appropriate for their intended use. She must prioritize, coordinate andor execute sample testing, summarize and interpret results, and provide input based on findings to inform technical development strategies, and to further develop and implement innovative analytical and automation technologies. She must draw upon a greater depth of knowledge and experience in GLPGMP and SOP Authoring and Implementation to author highquality, timely and appropriate technical documentation including laboratory records, SOPs Standard Operating Procedures, test procedures, protocols, technical reports, etc. Especially since this senior position requires the ability to guide and provide technical mentorship to junior staff, including leading development projects, collaborative qualificationvalidation exercises and guiding study designexecution by other team members which contributes to a culture of rigorous analysis, assessment, and creative solutions, we require a Ph.D. degree or foreign degree equivalent in Biological Science, Chemistry, Chemical Engineering, or related, plus 24 months of experience in an occupation related to Analytical Testing and Analysis. Such extensive education and experience are necessary for this senior position as she is a key contributor who fosters a climate of highly effective analysis and communication of data to resolve challenges through critical evaluation with supporting data, which ensure the companys continued and continuing success. As a result, we have determined that the educational and experience requirements for the position all bear a reasonable relationship to the occupation in the context of our business, and are essential to perform the job in a reasonable manner.
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