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Job Description: The Analytical Development Department is responsible for the successful and timely development of new pharmaceutical solid oral products by carrying out required analytical development services to clients. The primary responsibilities of this position are to provide analytical support for the Analytical Development team in the development, validation and transfer of analytical methods, with limited supervision. The Scientist will also perform routine analysis of APIs, excipients and finished products using laboratory techniques and instrumentation. Hands-on method development, method improvement, and validation, including but not limited to HPLC, GC, Dissolution, UV-Vis Spectroscopy, FTIR, Microscopy, PSD etc. Assists in complex experiments and tasks such as unknown impurity identification and excipient compatibility studies. Prioritizes activities to provide timely analytical support to product development. Anticipates analytical issues early in the R&D development process and provides long term planning for analytical method development and improvement. Supports formulation development and transfer activities for assigned projects. Supports the investigations of method performance, reliability and conducts optimizations studies, as needed. Participates in the preparation of technical documents, including validation protocols and reports, reference standard qualification reports and analytical test procedures. Education or Equivalent Requirements: BS, MS in Chemistry, Biochemistry or related discipline with 4+ years (BS), 2+ years (MS) of experience in pharmaceutical industry. Prior experience in Analytical R&D is preferred. Knowledge/Skills Requirements: Working knowledge of GXP, regulatory (ICH) and compendial (USP/EP/JP) requirements. Ability to multi-task and demonstrate diplomatic skills. Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization. Strong organizational skills. Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint). Ability to work effectively under pressure to meet deadlines. Physical Requirements: Individual may be required to sit, stand, walk regularly. Occasionally lift 0-15 pounds. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and frequent use of computer monitor. Individual’s primary workstation is in an office and laboratory area, where the noise level is low.

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