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Company Contact Info
- Andover, MA
- Phone: 973-984-7900
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Townsend & Associates • Andover, MA
Posted 18 days ago
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- 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.
- Work closely with development scientists/engineers, technical operations personnel, and manufacturing to ensure proper transition of processes from bench-top to manufacturing scale.
- Execute process operations according to SOP's, troubleshoot and resolve equipment issues and process disruptions, develop and implement process improvements, perform process monitoring, and support investigations.
- Review manufacturing procedures and share the responsibility of training production staff.
- Setup and evaluation of unit operations (daily and long-term).
- Process executions and changeover.
- Troubleshoot process disturbances, identify resolution and implement corrective and preventive measures, as required.
- 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, 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.
- Review process parameter tables and 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.
- Drive continuous improvement and innovation initiatives.
- 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.
- Review all documentation daily to ensure the highest quality with identification and prevention of any process and compliance trends, as required.
- Assume lead role in coordinating activities in absence of people leader and be a primary skill trainer for the shift.
W2 ONLY!!! NO CORP TO CORP
- A maximum of a BS/BA in Engineering or life science with 1-3 years' experience in a biopharmaceutical environment is preferred.
- 3-5 years related experience required.
- 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.
- Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.
- 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.