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Upsher-Smith Laboratories, LLC Associate Chemist in Maple Grove, Minnesota

T435 - 1B The Associate Chemist provides analytical and technical support for analysis of raw materials (drug substances, excipients, in-process samples, and packaging components) stability samples, and drug products. Completes testing in a timely manner and according to cGMPs, Test Methods, and SOPs. Supports commercial release testing, stability sample analysis, and process validation sample analysis to support business goals and objectives. Performs analytical testing using HPLC/UPLC, UV, IC, GC, and dissolution apparatus. Familiar with the function and operation of this equipment. Uses Empower Chromatographic Data Acquisition software to generate, analyze, and report data. Utilizes compendia such as USP and EP to perform analytical testing. Performs testing on raw materials, In-process materials, stability samples, and drug products to support Production, Sales/Marketing, Research .and. Development/Technical Services, and Quality Assurance/Regulatory Affairs. Performs tests accurately and correctly the first time, with minimal rework to meet timelines specified by Laboratory Management. Documents testing and aids in maintaining the laboratory according to appropriate GMPs and SOPs. Develops efficiencies in their day to day testing and provides suggestions for process/procedure improvements. Able to execute multiple tests accurately, correctly, and concurrently to support the department testing timelines. Communicates atypical and out-of-specification results to laboratory management. Takes an active role in supporting the investigations of atypical and out-of-specification results by utilizing critical thinking skills. Executes method transfer and process validation testing with oversight as needed. Cleans laboratory glassware, equipment, and work areas. Aids in ensuring that the laboratory environment is safe. Work independently or in a team setting, with minimal supervision. Addresses testing and interpersonal issues maturely and properly to maintain a cohesive team. Reviews analytical data as required. Responsible for identifying and communicating errors found in the documentation and testing. Displays increasing productivity by balancing multiple priorities. Routinely submits "right first time" work. Provides training to others as necessary. Works with supervisor to prioritize activities. Shifts priorities to meet business demands. Notifies management when timelines cannot be met. Self-motivated and focused on highest-priority tasks. Requirements: A Master's degree in Chemistry or related science field or a Bachelor's Degree in Chemistry or related science field with a minimum of 2+ years of experience in the pharmaceutical industry. Other Knowledge, Skills, and Abilities: Understands and performs HPLC, UPLC, IC, GC, and wet chemistry techniques as appropriate. Routinely handles chemicals. Evaluates lab systems and processes. Provides recommendations for efficiency improvements and cost savings. Evaluates lab procedures to ensure cGMP compliance. Possesses strong verbal and written communication skills. Has the ability to work independently and with others, and is able to multitask to maintain efficiencies. Has experience or training with Microsoft Word and Excel and other computer software systems (Empower). Required to wear safety glasses and lab coat while in the lab area. May be required to wear other protective equipment such as goggles, gloves, ear protection etc. 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


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