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The Cell Therapy Production Facility (CPF) is a department within the Therapeutic Products Program division that manufactures T-cell and stem cell therapeutic products for clinical trials. Within the CPF, there is a functional unit that supports clinical manufacturing by creating and/or revising manufacturing production batch records and SOPs. This position will oversee Process Engineering Specialists and Technical Writers in the development and creation of these GMP documents. They will also be responsible for development, facilitation and oversight of internal process and technology transfer from scientific and Process Development staff to Manufacturing personnel.
The CPF Process Engineering Sr. Manager will primarily focus on the oversight of MFG batch record development, creation and revision, with appropriate support of standard operating procedures, to ensure a continued state of regulatory compliance and continuity of clinical manufacturing operations.