Duties Collaborate with stakeholders to execute the transfer requirements of both late stage clinical and/or PPQ (Process Performance Qualification) programs. […]
Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch...