Project management and technical services consulting for fast-paced COVID-19 manufacturing facility start-up. Provided day-to-day planning and coordination for equipment procurement, installation, validation, and operational readiness.
Established standardized scheduling format for the installation of a new greenfield CMO facility. Led scope and schedule development with owner, designer, and trades. This included pull-planning sessions to ensure effective sequencing and coordination from design and procurement through start-up.
Served as owner's project manager for the design, execution, automation, and qualification of two bioreactor trains to address microbial control issues and improve reliability. Project consisted of improvements for two seed trains and a complete rebuild of the production reactors (4 x 15,000L) while maintaining one train in production at all times. Total capital investment of $20M.
Served as owner's project manager for the design, execution, project controls, and commissioning of a new centralized cooling tower plant (9,000 tons) and new chiller equipment that will service two existing facilities. Work included coordinating and transitioning to the new cooling tower plant within an allowable downtime of 24 hours to keep the facilities operational. Total capital investment of $21M.
Led project for new large-scale chromatography column movement solution in multi-product manufacturing facility. Served as project manager coordinating multiple vendors and owner staff for the design, fabrication, and implementation of new technology to replace existing pneumatic pallet design.
Led development of process simulation model using SchedulePro software for multi-product clinical/commercial facility to identify constraints for increasing batch cadence by 70%. Identified scope and led projects to eliminate identified constraints, including improvements to buffer handling, WFI storage/distribution, process waste, and process glycol capabilities.
Executed a project focused on reducing operational risk through effective spare parts management for an existing multi-facility site. Developed and managed processes for field data collection, subsequent risk assessments for determining part criticality, and SAP restructuring for inventory management.
Owner's representative for a greenfield manufacturing facility to support clinical supply and commercial launch. Providing process/automation support in the development of owner's project requirements, scope packages, process flow diagrams, facility risk assessments, automation strategy, and equipment specification and procurement.
Serving as owner's project manager for the design, execution, qualification, and project controls of a GMP facility expansion for a new coating and packaging line. Project will be implemented without impacting adjacent active production facility.
Built capital portfolio/project management processes and toolkit within big pharma corporate infrastructure to streamline and standardize implementation of site capital portfolio. Annual capital budget ranging from $25-50M.
Performed an assessment of critical utilities to identify gaps in the preventive maintenance program. Recommended and implemented changes to improve reliability and compliance. Deliverables included as-built drawings, guidelines, and preventive maintenance tools to improve maintenance practices and appropriately document the work performed in a GMP-compliant manner.