Research Scientist, Analytical R&D

Location: NC
Job Type: Direct Hire
Salary: $70,000.00 - $90,000.00
Date: 9/5/2018
Job ID: 02601526
Job Description
Summary
We are currently accepting resumes for the position of Research Scientist in Analytical R and D/Methods Development and Validation.
Responsibilities
  • Must be fully capable of developing analytical methods based on experience, literature search, etc.
  • Design, develop, conduct and/or review experiments including method development and method
  • transfer; perform methods validations utilizing typical instrumentation including but not limited to LC,
  • MS, GC, etc.
  • Interpret data from routine and non-routine analyses in order to develop workable test methods
  • and/or deduce and test mechanistic or systematic hypotheses;
  • Familiarity with other instrumental methods (IR, NMR, XRPD, TGA, KF, etc.) as well as non-
  • instrumental methods (wet chemical methods);
  • Perform data audits in order to ensure accuracy of data and analytical processes;
  • Act as scientific, regulatory, technical or quality expert and consultant by responding to targeted
  • questions from and providing support to customers;
  • Provide leadership including cross-training and technical development to the GMP Analytical laboratory colleagues;
  • Organize workflow and tasks to maximize laboratory efficiency (e.g., prioritize sample analysis, manage/assign tasks, preventative maintenance);
  • Maintain laboratory equipment and instrumentation (e.g., troubleshooting, conducting preventative maintenance, calibrating and repairing);
  • Participate in the laboratory quality system activities such as internal audits, writing standard operating procedures, and documentation review;
  • Prepare samples for analysis and record data from analyses or experiments in a computer, log book, or laboratory notebook;
  • Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines. The successful candidate will hold a PhD or MS in Chemistry (or closely related discipline) with 7-10 years relevant experience, or a BS degree with 12+ years relevant experience, having a broad background, strong comprehension, and demonstrated skills in the analytical methods validation/development areas. Aptitude in the area of Project Management is also a strong positive. A minimum of 7-10 years of relevant background in a cGMP-compliant pharmaceutical laboratory environment is required for consideration. In-depth work experience in an analytical contract laboratory environment is a strong positive. Experience in stability study performance/evaluation is helpful. Demonstrated project management skills is also a strong positive. Expertise in USP/compendial testing is vital. Excellent verbal and written communication/interpersonal skills, problem-solving skills, organizational skills, and the ability to work in a diverse team environment are essential. Proficiency with Microsoft software (Word / EXCEL / PowerPoint) is expected. The company offering parallels the drug discovery process and provides significant advantages at each step from lead discovery to lead optimization, chemical synthesis and scale-up of pharmaceutical intermediates as well as chemical process R&D.