Responsibilities will include, but are not limited to, the following:
1. Execute/implement Clinical Production batch records for the following areas: cell culture, cell harvesting, tissue processing (placenta), cryopreservation, etc.
2. Maintain and deliver sufficient supply of appropriate grade material for clinical studies in accordance with timelines, and participate in clinical supply campaigns
3. Perform tasks in the absence of supervisor
4. Coordinate daily laboratory tasks
5. Contributes input toward the revision of Standard Operating Procedures (SOPs)
6. Daily review of batch records
7. Prepare and maintain cell culture reagents and media
8. Ensure sufficient laboratory supplies for daily laboratory operations
9. Ensure proper operation and perform routine maintenance of all laboratory equipment
10. Assist other staff to complete all laboratory tasks as necessary
11. Follow SOP’s associated with processing of Clinical Grade Cellular Therapeutics.
12. Responsible for entering processing data into Batch Records
13. Proper handling and storage of products into a designated freezer or liquid nitrogen tank
14. Operation of laboratory processing equipment, including Biosafety Cabinets and Clean Rooms
15. Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices
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