Process Development Technician

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. Will work closely with development scientists/engineers, technical operations personnel, and manufacturing to ensure proper transition of processes from bench-top to manufacturing scale. Responsibilities include the execution of process operations according to SOP's, troubleshooting and resolution of equipment issues and process disruptions, developing and implementing process improvements, performing process monitoring, and supporting investigations. Will review manufacturing procedures and share the responsibility of training production staff.

Responsibilities:

• Execution of relevant process activities by following established SOP’s.
• Setup and evaluation of unit operations (daily and long-term)
• Process executions and changeover.
• Troubleshooting of process disturbances, identifying resolution and implementing corrective and preventive measures, as require
• Real time assessment of process performance.
• Perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings.
• Ensure timely investigations of unexpected data and trends with the guidance of a people leader and/or group leader.
• After attaining a detailed knowledge of the operational equipment for each unit operation, individual will be required to solve routine technical problems associated with site assessment, yield and enzyme kinetics, phenotypic evaluation, growth and enzyme kinetics, and metabolism of specific unit operations used in biopharmaceutical manufacturing.
• Serve as the operations point of contact for technology transfer and start-up of products by reviewing process parameter tables, site assessments, review and approve plant documentation, change controls, process overview presentations, sampling plans, and other tech transfer deliverables.
• Assist in inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment and modify and/or create job related documentation
• Evaluate and implement new technology for process execution or analysis.

QUALIFICATIONS:

• Knowledge of cGMP, cell cultivation techniques, cell separation operation with TFF and/or centrifugation, column purification /membrane based operations, and equipment IQ, OQ, PQ approaches are desirable.
• 1-3 years experience in a biopharmaceutical environment is 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.
• Provide subject matter expertise in supporting process and product related investigations, execute CAPAs and provide input to process and equipment change controls to ensure robust and capable solution.
• Perform clear and concise documentation following relevant SOP’s 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 require.
• Assume lead role in coordinating activities in absence of people leader and will be a primary skill trainer for the shift.

• REQUIRED 3-5 YRS RELATED EXPERIENCE

Education:

• A maximum of a BS/BA in Engineering or life science field

All your information will be kept confidential according to EEO guidelines.