Lead an Upstream process development team that was responsible for post-approval process improvements as well as supporting seasonal influenza screening in our MDCK platform.

Upstream lead on tech transfer work on the Norovirus Vaccine candidate from the US CMO to Takeda Vaccines in Hikari Japan. Worked in a global assignment in Japan for two years to better support the transfer process as well as full scale GMP manufacturing. My responsibilities also included Project Management duties helping to facilitate strong communication between US based and Japan based teams. I also coordinated and lead internal cross functional meetings to ensure strong execution of divisional KPI's

Worked on process development activities related to the Norovirus Vaccine canidate. Was part of a cross functional group to evaluate improved manufacturing processes and other possible sites for manufacturing. Acted as the upstream technical lead for the early transfer activities of the Norovirus vaccine candidate manufacturing to Takeda's site in Hikari Japan. In this role I collaborated with scientist from Hikari and provided instruction and support for the 10L small scale transfer to Hikari.

Worked on process development activities related to the Norovirus Vaccine candidate. Executing experiments based on DOE principles to better characterize our process and support ongoing clinical manufacturing.

Worked in Upstream Process Development for Antibody processes in the CHO cell system. Helped develop the ATF small scale model for Amgen as well as clone screening on both FIH and Phase III projects.

Conducted experiments for Upstream process development of Antibody processes using the CHO expression system. Media development, clone screening, as well as DOE process optimization.

Sr. Associate in the cGMP clinical manufacturing group at Amgen. Knowledge with cGMP, Change Control, deviation management, PasX and Werum weigh and dispense systems, computer system validation, SIP, CIP. Operational excellence and continuous improvement principles

Worked in the upstream clinical manufacturing group at the 2000L scale. Responsible for manufacturing of monoclonal antibody clinical trial material under cGMP guidelines. Experience with SIP, CIP and COP as well as shake flask and media compounding. Utilized Kanban raw material management theories as well as continuous improvement principles.