Associate Scientist / Scientist - Analytical R&D Allegan United States,
The Analytical R&D Associate Scientist will provide technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards. The incumbent will work with minimal supervision and, as appropriate, may serve as a project leader to manage analytical support for projects with supervision. The incumbent will perform physical and chemical testing on raw material, in-process, finished product and stability samples, including documentation and review. The Associate Scientist will develop, validate and transfer non-complex analytical methods and assist in researching, preparing and reviewing technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards. The Associate Scientist will utilize skills, established procedures, new methodologies, and experience to complete tasks; and may provide formal and informal mentoring to interns and Technicians. The incumbent may also investigate and resolve moderately-complex analytical problems, project issues and deviations and attend and present data at project-related meetings, interact with other departments and outside testing laboratories to ensure proper analytical testing.
A Bachelor degree in Chemistry or Pharmaceutical Sciences combined with 1 to 5 years of relevant experience in a cGMP or cGLP laboratory is required. Demonstrated proficiency in the use of a variety of standard analytical instruments, such as HPLC, UPLC, GC, Dissolution, UV-Vis and FTIR. Familiarity with a variety of compendial references, including USP or European Pharmacopeia. The ability to develop, document and execute analyses or experiments of moderate complexity, ensuring methods are robust and reliable. The ability to maintain high quality research documentation, analyze and interpret data, and prepare reports, qualification documents, SOPs or other technical reports is necessary. Must be able to work independently on multiple concurrent projects, and communicate effectively with interdisciplinary project teams.
An Equal Opportunity Employer - M/F/D/V
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