Duties and Responsibilities (Include but are not limited to): Lead and perform hands-on analytical work including method development, qualification, validation, transfer to internal and external QC labs, lifecycle management, and author associated documentation (method development reports, technical reports, qualification / validation reports, method SOP etc.). Lead and perform hands-on method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, continuous method improvement initiatives, and author associated documentation.