Manager, Analytical Development
CurrentCollaborate across R&D departments to provide analytical support on multiple development projects and lifecycle management activities. Serve as technical expert for advanced, non-routine analytical techniques. Support the assessment, build-out, and deployment of workflow management systems (LIMS, ELN, CDS, etc.) in R&D. Lead team of analytical scientists in development of 505(b)(2) injectable products. Serve as Principal Investigator for GLP studies. Champion aspects of Analytical Quality by Design (AQbD) throughout project development lifecycle. Lead Quality by Design (QbD) activities for cross-functional R&D team towards clinical trial readiness.