Senior Scientist II Process Development (2 Positions)

The Senior Scientist II Process Development in the Therapeutics and Production Quality Department will operate in an independent fashion with minimal daily supervision to design mammalian cell culture processes for the production of biotheraputics, including adeno-associated gene therapy vectors for the cGMP facility. Ensure processes meet the requirements for drug substance and drug products as mandated by the Food and Drug Administration. Maintain excellent notebooking skills and generation of reports that summarize all process development activities with publication quality. Develop production batch records in collaboration with the Quality Assurance Department and Children's GMP, LLC. Develop production associated documents to support successful manufacture of products, meeting or exceeding all quality indicators, as needed. Schedule and coordinate assignments with other cGMP facility departments to achieve process development goals.Ensure that all production personnel receive appropriate training of processes transferred from Process Development into cGMP manufacturing. (MJP)