Manufacturing Specialist Job in Pine Brook 07058, New Jersey US

Position Description: Support in-plant process activities for Bulk drug substance and aseptic filling at CMOs.  Provide support for process validation, and resolution of technical issues during cGMP aseptic liquid fill/finish of a monoclonal antibody at CMO. Provide assistance with GMP document review and revision including batch records, SOPs, deviations, change control requests, and reports in support of bulk drug substance and final drug product manufacture.  Assist with preparation of CMC submissions. Provide assistance in formulation development and tech transfer activities to support a Read more […]

September 10, 2009 • Tags: , • Posted in: General • Comments Off on Manufacturing Specialist Job in Pine Brook 07058, New Jersey US