The Research Scientist conducts research in the area of sterile products and the manufacturing of sterile products for the pharmaceutical industry and federal agencies including studies involving formulation development, end project testing, such as sterility and stability-testing, development of freeze-drying cycles and the aseptic of hard to manufacture drugs.
DUTIES AND RESPONSIBILITIES:
Conducts research and analytical studies for the formulation development of novel drug products and semi-solid, liquid products. Completing formulation and process development, and stability testing.
Develops parenteral products under current Good Manufacturing Practices (GMP) for pre-clinical and Phase 1 and 2 clinical trials material. Establishes deliverables in the new product development and technical review process.
Performs real-time and accelerated stability studies, meeting current regulatory compliant stability guidelines.
Reports and updates laboratory records with respect to the project(s) and in respect to all equipment document and validation.
Evaluates and reports collected data with respect to the projects, both research and manufacturing.
Provides one-on-one training to professionals from the pharmaceutical industry and regulatory agencies in the Hands-On Training Program in Aseptic Processing.
Prepares and reviews standard operating procedures. Implements new and improved operational procedures and processes for compliance with Good Manufacturing Practices regulations.
Provides technical strategies and guidance to support new product process development and scale-up using Quality by Design tools.
Identifies critical process parameters (CPP) and defines process unit operation design space and range.
Supervises the day-to-day technical work and line management of new employees and mentor their technical and professional development.
Testing method development and validation, and stability testing of semi-solid dose and parenteral formulations.
Maintains training and research laboratories and the department's physical characterization equipment; installation and qualification (IQ&OQ), calibration and maintenance, and daily performance checks, operator training, and GMP documentation.
The mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research, clinical care, and public service.