The Process Design and Development group is responsible for the chemistry, formulation and engineering efforts to support development and scale-up of investigational small molecules to support clinical and toxicology studies through late stage clinical trials. Through application of scientific training and relevant experience, a team of scientists design a synthetic route, develop the formulation, and support the clinical manufacturing and commercialization of new drug candidates.
Key responsibilities: • Supports Chemical Process Scale Up and Development • Understands and complies with corporate, divisional, and departmental procedures, including safety and other applicable regulations. • Sets up and operates lab equipment. • Contributes to the implementation of appropriate analytical methodologies • Makes interpretations of data he/she generates and suggests subsequent experimentation. • Offers ways to improve efficiency of time utilization. • Accurately follows written and verbal directions, including complex experimental designs. • Keeps accurate documentation including proper use of laboratory notebooks, provides written summaries for supervision, when requested. • Summarizes, prepares, and tabulates data and works with other laboratories and support groups. • Has a basic understanding of computer systems and programs for the development project activities. • Follows all safety and quality procedures and standards • Reads MSDS of all chemicals before starting the experiments. • Understands all process lines and process flows. • Responsible for equipment start up, operation, shutdown and cleaning • Takes samples manually during the experiment. • Records relevant process data, such as exact times that step changes are made to process conditions and that samples are taken. • Uses PLC (DeltaV and/or Horner) to control and monitor the process
Skills: • Knowledge of safety and environmental guidelines • Knowledge of Good Documentation Practice • Communication skills • Team working skills • Problem solving skills
Educational Requirements: • High School Diploma required • Post-secondary education desired