Senior Manager Process Development At Pfizer
CurrentManager of MSAT pilot cell culture, purification, and process services laboratories.Leading a team of 14 scientists to support commercial products and deliver next generation processes.Responsible for technical transfers and new equipment testing at pilot scale that will reduce risk for commercial transfers.Serve as building manager ensuring all utilities and facility maintenance and upgrades are completedTechnical Product Lead for two commercial Haemophilia products Chair bi-weekly technical team meetings where progress on major projects is presented. Change controls, deviations, investigations, and potential risks are reviewed.Major contributor at monthly product team meetings and work with Product Portfolio Lead to provide technical support to strategic initiatives.Insourcing lead for the successful transfer of a Haemophilia drug substance from a CMO to a Pfizer site. Accountable for:Ensuring successful transfer of commercial process to include Completion of drug substance and drug product process validation (PV) batches Completion of process, product and non-clinical comparability exercise Manage timely authoring and submission of regulatory filing documentsEnsuring program proceeds to meet schedule Managing interface with CMOIdentifying and managing project risk and communicating updates and issues to key partners and stakeholders. During insourcing project served as chair of Steering team committee.Responsible for transformational increase in team capabilities achieved by successfully obtaining increased Capex budget and subsequently delivering capital equipment and facility improvement projects totalling €30 million. Delivered multiple facility upgrade projects, including delivery of new RNA Technologies lab. Developed concept, sourced funding. Led and delivered RNA lab on schedule and on budget.
