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Upsher-Smith Laboratories, LLC Principal Chemist - CAS in Maple Grove, Minnesota

T007 - 4A The Principle Chemist provides a broad analytical and technical leadership to support new product development. Will lead or serve as a cooperate resource to a multidisciplinary team to resolve critical or complex technical problems and provide coaching and mentorship to junior chemists. Responsibilities include, but are not limited to: application of QbD principles in developing robust methods that are time tested in a routine quality control environment; Leading method troubleshooting and rectify challenges including trace analysis using a variety of techniques including advanced principles and concepts; Leading method validation and drive continuous improvement of Upsher-Smith Laboratory method validation process; Application of in-depth knowledge in impurity identification including isolation of the component of interest, application of appropriate methodologies for identification, accurate interpretation of data, and the tenacity to bring the task to a logical conclusion; Reviewing and leading laboratory investigations to identify the root cause and implement resolutions; Author and critically review protocols, reports, methods, specifications, cross-functional presentations, and USL position papers regarding draft policies from USP, FDA, and ICH; Authoring or critiquing the CMC section for a regulatory submission; including assembling information packages to support regulatory submissions or meetings; Leading external publication of a minimum of three (3) articles in reputable scientific journals post graduate training. Requirements: PhD in Analytical Chemistry or related disciplines with minimum of 9+ years pharmaceutical R.and.D experience in analytical method development, or MS with 12+ years or BS with 18+ years. Expert knowledge in HPLC and GC method development for stage appropriate drug development. Extensive knowledge of current analytical methodologies for trace level impurity identification and quantitative analysis. Thorough knowledge of FDA guidance for the Industry, and ICH guidelines as they related to DS and DP characterization, control, and stability. Thorough knowledge in GMPs as they relate to analytical support. A successful track record in providing regulatory submission documents for IND, NDA, and ANDA. Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.