Description
Job Description:Responsible for execution of the manufacturing process in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance.
Responsibilities:
Individual will work in highly integrated and fast paced interdisciplinary team on process scale up activities, process troubleshooting, and cGMP manufacture of clinical and commercial drug substance. Execute process operations according to SOPs, troubleshooting and resolution of equipment issues and process disruptions, developing and implementing process improvements, process monitoring, and supporting investigations. Execute relevant process activities by following established SOPs. Setup and evaluation of unit operations (daily and long-term). Process executions and changeover. Troubleshoot process disturbances, identifying resolution and implementing corrective and preventive measures, as required Perform Real Time assessment of process performance. Ensure timely investigations of unexpected data and trends with the guidance of a people leader and/or Engineer. Assist in inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment and modify and/or create job related documentation. Drive continuous improvement and innovation initiatives. Perform clear and concise documentation following relevant SOPs and electronic instructions. All documentation must be reviewed daily ensuring highest quality of documentation with identification and prevention of any process and compliance trends, as required.
SKILLS:
Position Qualifications:
Good Manufacturing Practices (GMP) required, MS Excel desired. A minimum of a Bachelor's degree or 1-3 years experience in a Biopharmaceutical environment preferred. Willingness to work in a challenging environment that requires execution of new processes or stable processes. Mechanical aptitude is a plus, as many operations require manual intervention as well as use of automation. Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment. Knowledge of cGMP, cell cultivation techniques, and cell separation operation with centrifugation approaches are desirable.