Description: Prospective students to work closely with engineers and the compliance team to help solve manufacturing, equipment, and facility related issues in a highly regulated cGMP (current Good Manufacturing Practices) environment. Student to support the biologics business unit ensuring continued delivery of high-quality products to patients. Responsibilities: Troubleshooting equipment issues (Deviations) Investigating equipment related failures (Investigations) Implementing equipment related changes (Change Control Records (CCRs)/ Corrective Actions and Preventative Actions (CAPAs)) Updating drawings Updating procedures Specifying parts Capturing user requirements Walkdown …
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Genomic Medicine Purification Process Development Co-Op, Waltham, MA Position Overview/Department Description The Genomic Medicine Unit (GMU) Chemistry, Manufacturing and Control (CMC) group at Sanofi is dedicated to the establishment of best-in-class manufacturing platforms to support development of life-changing advanced cell and gene therapy products, including recombinant Adeno-associated viral vectors (AAV), non-viral and cell therapy products. This 6-month position centers on drug substance process development for gene therapy but will interface with a broader team of vector and cell line engineering, …