Research Scientist-Plough Center

University of TennesseeMemphis, TN
8d

About The Position

The Research Scientist conducts research in sterile products and the manufacturing of sterile products for the pharmaceutical industry and federal agencies. Included are studies involving formulation development, end project testing, such as sterility and stability testing, development of freeze-drying cycles and the aseptic filling of hard-to-manufacture drugs. The Plough Center for Sterile Drug Delivery Systems, formerly known as the Parenteral Medications Laboratories (PML), provides training in sterile product preparation to academic, as well as industry, professionals. Additionally, the Center is actively involved in the design and development of novel parenteral drug products for the treatment of high-morbidity diseases.

Requirements

  • Master’s Degree in Chemistry, Pharmaceutical Science, or a related field. (TRANSCRIPT REQUIRED)
  • Five (5) years of sterile manufacturing experience in aseptic processing and analytical work necessary for in-process testing of aseptically produced products.
  • Capable of working according to current Good Manufacturing Practices and Good Laboratory Practices.
  • Thorough knowledge of analytical testing and data analysis.
  • Knowledge of the sciences surrounding formulation development and development of drug products, testing of drug products, and aseptic processing procedures.

Responsibilities

  • Discovers formulations, advanced R&D collaborations and projects from laboratory to scale-up.
  • Performs data analysis, evaluation, compilation, and documentation of research/experimental data.
  • Researches and develops quality control activities, data integration and data storage.
  • Assists in generating research and project proposals, including technical and cost calculations.
  • Performs cGMP cleanroom manufacturing operations as directed by the supervisor.
  • Inputs R&D data to create documentation of Batch Production Records.
  • Reviews instrumentation capability, prioritizes, and justifies equipment requirements based on projects.
  • Provides hands-on training program in aseptic processing.
  • Communicates effectively with supervisory personnel and meets timelines of client deliverables.
  • Remains updated with regulatory guidance and compliance relevant to GxP.
  • Performs other duties as assigned.
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