Job Title

Essential Duties and Responsibilities This is a 2nd Shift role. Regular work hours are 4:00pm - 1:00am, Sunday through Thursday. Works on complex problems in which analysis of data requires evaluation of various factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Responsible for conducting routine and non-routine analysis of In-Process/Reaction intermediate and Finished materials according to standard operating procedures. Compiles data for documentation of test procedures and prepares reports. Calibrates and maintains lab equipment. May develop testing methods. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. Applies knowledge of good manufacturing practices and good laboratory practices daily basis. Works on complex problems where analysis of situations or data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Acts independently to determine methods and procedures on new assignments. Provides data analysis, troubleshooting and problem solving. Provides training to junior analysts. Supports QC release and stability testing. Performs various analyses, such as NMR, HPLC, UV-Vis spectroscopy, GC, particle size determination and moisture analysis. Maintains accurate and well-organized laboratory records and worksheets. Assists with other projects as assigned. Recognize OOT/OOS results and appropriately conduct investigation. May perform rotational on-call duties for monitoring of storage chambers, as necessary Minimum Qualification Requirements A minimum of a Bachelors degree in a scientific discipline with a minimum of 5 years cGMP analytical experience is required. Must have a demonstrated working knowledge of scientific principles. Practical experience in analytical chemistry and general laboratory wet chemistry techniques required. Experience in HPLC a must, with GC/ NMR experience, being a plus. Experience in data analysis, troubleshooting and problem-solving skills is a must. Knowledge of FDA regulations and cGMP experience required. Experience in data analysis, troubleshooting and problem-solving skills is required. Good oral and written communication skills are required. Good computer and documentation skills are required. Experience with Empower software is required. Must be well organized and willing to work as part of a team. Must be able to work independently and flexible. Physical Requirements Must be able to pass pre-employment drug screening and background check for employment consideration. Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function. Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices. Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents. Employees must be able to maneuver themselves under 30 inch clearances. Employees must be able to able to accurately detect color and have 20/20 vision (with/without corrective lenses).