Provides guidance (scientific and administrative) for junior analytical scientists. Liaison between functional groups as well as sister divisions for a wide variety of analytical aspects including the meaning of analytical data from various sources; how the analytical data meets the client's needs; the quality aspects of analytical projects and also timelines for analytical projects. Proactively and cooperatively communicates with peers, and communicates with management by proactively keeping management informed of results, of obvious and subtle problems and likely potential problems, alternative and their consequences. Develops and validates a wide variety of analytical test methods (i.e. ID, potency, impurities, solvents, particle size, etc.) and routinely keeps supervisor informed of progress and issues. Recognizes simple and complex technical issues which arise during methods development, evaluating alternatives and initiating corrective actions. Must work independently to validate a wide variety of analytical test methods (ie. ID, potency, impurities, solvents, particle size, etc.) using a variety of validation approaches. Routinely keeps supervisor informed of progress and issues. Initiates test method transfers by defining, interpreting and recommending acceptance criteria, proactively communicating with the other lab(s) and ensuring testing is completed in a timely manner. Proactively solves simple and complex problems through job knowledge, use of technical resources including technical literature and experts and well formulated, logical experimentation. Routinely makes recommendations to management regarding areas for development in order to reduce and control current and/or future problems. Follows, understands and complies with AbbVie SOP's and policies on cGMP's and safety. Maintains a clean, safe and organized lab area, and may be responsible to ensure others maintain their lab areas. Often acts as role model for other scientists. Participates in drafting new SOP's and policies. Accurately records own data and results in a timely manner and in compliance with appropriate quality standards. Has own data verified in a timely manner. Responsible for verification of data, protocols, and reports in a timely manner. Manages whole projects. May establish schedules, project plans and direct activities of other scientists and non-scientists as well as provide training and development for others. Write/co-author memos and scientific reports in support of Regulatory Submissions, Regulatory Field Alerts and support quality control and manufacturing documents. Education Requirements: B.S. in Science or related field with 10-14 years relevant experience or M.S. in Science or related field with 5-9 years relevant experience preferred, or Ph.D. in science or related field, 4-7 years post-graduate and/or industrial experience preferred. Experience Requirements: Knowledge of computers and wide analytical experience in wet chemical, physical property testing, chromatography and/or spectrometric methods. Has strong problem solving abilities. Good organizational skills. Excellent communication (oral and written) and interpersonal skills. Can function as team player. Must be able to work with Commercial Operations to determine prioritization of projects and meeting tight deadlines. Use good judgment and make sound decisions. Needs to be adaptable and maintain the ability to be flexible in an ever challenging environment. Posted by StartWire
Ciudad: barceloneta
