Executive Director, Microbiology

Job description

Job Description The Executive Director, Microbiology is accountable for providing strategic and technical leadership supporting small molecule, biologics and vaccine candidates in the clinical development space across the Microbiology Network (site-based teams in Rahway, NJ; West Point, PA; Schachen, Switzerland). This includes oversight of GMP release and stability activities supporting the development pipeline, facility environmental monitoring, analytical method transfers from embedded microbiology development teams, transfer support to commercial sites, and support for regulatory filings including INDs, IMPDs, NDAs, and BLAs. The team is also responsible for molecular and viral screening, cell bank testing oversight, and the evaluation and implementation of new analytical technologies, including the continued development and execution of advanced microbiology methodologies. Strategic partnering among Analytical, Process, and Formulation Research & Development teams; CMC and Regulatory functions (particularly around control strategy and regulatory filings); and Quality, Commercialization, and Manufacturing partners is essential to enable robust product and process development, e...