Lars Waldmann

Experience

1. Director, Production Operations

   Curia Global

   Jan 2023 — Present · Burlington, MA, US

   Responsible for component preparation, formulation, filling (vial and prefilled syringe), and visual inspection of the Curia Drug Product CDMO Burlington siteManage staff of up to 50 FTEs as part of different departments; in Manufacturing, manage up to 5 shifts for 24 hour and weekend coverageClosely partner with Site Head of Quality to foster Quality-driven culture, right first time execution of manufacturing operationsManage Process Development and Technical Operations teams who support manufacturing activities, tech transfers, process changes, batch record changes, CAPAs, change controls, deviation investigationsSupport challenging processes, including polymer-based, highly viscous, solvent-based, aseptic formulations, controlled substance APIsOverseeing training and development of the workforce, including improvements to the training program and development of on the job (OJT) training modulesReporting KPIs to upper management, prepare presentation materialsRepresent department in regulatory and client auditsPartner with Business Development and Proposals Teams to improve marketing of the site and quality of proposalsSupport business development activities, development of proposals, host clients onsite, lead technical discussions

Education

• The Martin Luther University of Halle-Wittenberg

  Doctorate, Biochemistry