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Biologics Manufacturing Technician
2 months ago
We are seeking a highly skilled and detail-oriented Biologics Manufacturing Technician to join our team at Nationwide Children's Hospital. As a key member of our Biologics Manufacturing Resource (BMR) team, you will play a critical role in supporting the production of cell-based therapies in our Good Manufacturing Practices cleanroom facility.
Key Responsibilities- Participate in all day-to-day BMR production operations, including execution of production processes, documentation, and equipment maintenance.
- Work in collaboration with BMR Management and staff to enact the strategic direction of the BMR, including project timelines and capabilities.
- Support BMR resources and supply chain, including maintaining materials inventory control to meet production goals.
- Operate and perform the calibration, validation, cleaning, and maintenance of facility equipment and systems as specified in SOPs.
- Perform daily operational activities related to the manufacturing of biological products, by executing production processes, including assuring the availability of materials and the proper documentation surrounding BMR activities and product quality.
- Assist in process documentation review, revision, remediation, and process change controls.
- Assist the BMR Management and staff with deviation investigations, Out of Specification results, and process troubleshooting.
- Work in close collaboration with BMR Management to ensure continuous improvement objectives are identified and met using metrics and other statistical means.
- Work in collaboration with BMR Management to ensure new projects and technologies are incorporated into the BMR.
- Requires a minimum of a BS or BA with a scientific background.
- Minimum of 0-1 years of experience with an appropriate scientific or manufacturing background.
- Knowledge in aseptic technique, cell culture, liquid separation techniques, and/or fluid handling. Alternatively, must be able to be quickly become proficient in these techniques after training.
- Must be computer literate with experience in Microsoft Office products.
There are very minimal physical requirements. One needs to be able to lift 20-30 pounds occasionally (0-33% of the time). One must be able to don sterile gowns appropriately and work in a cleanroom environment.
