We are looking for a Project Manager that will be responsible for a process optimization project within the in‐process lab to support a significant operational ramp‐up planned for the coming year. Daily production capacity is expected to more than double by the end of the year. The primary objective of this project is to enable this capacity increase without a proportional increase in headcount (i.e., avoiding a 2 to 2.5× increase in headcount). To achieve this, we are seeking support to assess, optimize, and redesign laboratory processes using Lean principles, with a focus on efficiency, flow, and waste reduction while maintaining compliance and data integrity.Scope of the project: In-process testing, Environmental Monitoring sampling of the aseptic facility and sample management. The contractor is expected to collaborate closely with internal stakeholders and ensure that all proposed changes are feasible within a regulated laboratory environment.
Expected deliverables:Current-state assessment: Assess the current structures, processes & performance, identifying operational constraints, workload variation, inefficiencies, and non‐value‐added activitiesFuture-state process design: Identify and quantify opportunities to improve capacity, efficiency, and throughput aligned with Lean principles that supports the projected capacity increase without proportional headcount growthQuantification of expected benefits (e.g., cycle time reduction, resource optimization)Provide a clear implementation plan, coordinate, and support execution
Required profile:Certified black belt certified (but accept green belt if proven experience in regulated environment)Lean project belt trainingExperience in regulated environment is key is needed (pharma, biotech – aware of regulation)EnglishStrong stakeholder management / communication skills with local teamsPM skills