Technical Project Support Specialist

Set-up and facilitate key analytical-focused team meetingsCoordinate authoring, review and approval of critical analytical documentsPerform second-person review on analytical reports and memosGeneral operational support for analytical working groups for commercial biologic/vaccine programsCollaborate across internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of large molecule analyticsCoordinate with analytical and process development groups to prepare for analytical troubleshooting, validation, and technology transfersSupport coordination of analytical activities across teams of subject matter experts to maintain or troubleshoot biochemical, immuno-chemical and chromatography-based analytical methodsSupport coordination of analytical method transfers and/or assay method validations, including authoring and coordinating review of protocols and reportsProject manage change controls related to analytical method or specification change controls