Phoenixville, Pennsylvania, United States
Transformational strategist with 30+ years of executive leadership, specializing in process improvement, client satisfaction, and business performance. Skilled at leading enterprise change initiatives to drive profitability, growth, and competitive advantage through revenue generation and cost reduction. Demonstrated ability to turn strategy into actionable plans that achieve results. Results-oriented leader skilled at building consensus, managing stakeholders, and communicating effectively. Experienced mentor who motivates teams and supports high performance across large organizations with a strong work ethic. Skills: Lean Management Transformation Budget Management Lean Six Sigma Theory of Constraints Process Excellence Continuous Improvement Project Management Operations Management Contracts Procurement Logistics Supply Chain
Currently the Site Head/Director of Operations for the Malvern facility which supports Clinical Supplies Management and BioSample Management operations. Requested by the Divisional Vice President to assume responsibility for P&L and daily operations to bring the facility into compliance with improved operational excellence. Improvements in shortened order fulfillment time to next day or sooner, overall audit compliance, right first time and on time delivery of Client deliverables as well as consistently meeting or exceeding budget. Consistently meet target KPIs for safety, quality, cost delivery, and People within lean management.
Spearheaded continuous improvement initiatives within Clinical Supplies Management on a global scale, collaborating across business units to develop efficient processes, user requirements, and systems. Managed a Process Excellence team to mentor colleagues in process improvement and change management competencies. Identified opportunities for process optimization throughout Clinical Supplies and led efforts to standardize invoicing, resulting in the recovery of $700K in previously unrecognized revenue and a monthly increase of $100K in the US region. Drove global process standardization via workshops and cross-functional teams and implemented demand and operational planning models—introducing front-end project contracting procedures. Standardized project management tools and scheduling practices to support lean operations. Leveraged lean and single-piece flow methodologies to end shipping backlogs during the Covid pandemic, ensuring uninterrupted patient dosing despite increased cold chain shipment demands.
Oversee and further develop the US Project Management Department, making up twenty project managers responsible for a $60M project portfolio. Lead strategic planning initiatives, assess workloads across various sites and personnel, and ensure client clinical trial deliverables are met within established budgets while maintaining high customer satisfaction. Standardize procedures between US and EU locations to facilitate resource allocation and workflow efficiency. Direct resources to achieve timely delivery to clients and coordinate with the Business Development team to define contract specifications. Supervise Project Managers in the design and implementation of clinical studies, including activities such as packaging, labeling, dispensing, and distribution of clinical trial materials and ancillary supplies. Provide oversight for the creation, review, and approval of process documents and schedules, ensuring alignment with client requirements and strict adherence to timelines. Guarantee correct billing and thorough documentation of all project planning hours and activities. Serve as the primary liaison between clients and CSM, including travel to client facilities as needed. Collaborate with Operations team members to monitor outstanding requests and work closely with US Team Leads to uphold consistency and identify potential areas for improvement. Partner with the EU Project Management Director and Team Leads to harmonize project management processes across regions. Work alongside the Vice President of Operations to address, investigate, and resolve client concerns, inquiries, and challenges.
Led lean transformation and change management across four divisions, aligning projects with scalable goals. Managed stakeholder relationships and strategic transactions, delivering financial analysis and dashboards. Advised on strategy and implementation for project teams of up to 25, acting as SME for Smartsheet on 60+ improvement projects in three years. Implemented an enterprise cost-savings model, authored SOPs, developed financial models, and projected increased ROI. Developed a global scheduling tool for 10 sites, reducing overtime and improving labor use. Oversaw data projects, improved SAP hierarchy, LIMS intake, and project visualization for scale-up.
Oversaw daily activities of the formulations department, which included 14 research associates, technicians, and lab assistants. Acted as subject matter expert in compliance areas such as Environmental Health and Safety, DEA regulations, and import/export of materials, as well as preclinical formulations and operational processes. Evaluated studies, developed protocols, and prepared formulations to meet client requirements for pharmaceutical, biotechnology, and agricultural companies. Maintained records, prepared technical documentation, and provided laboratory support at the site. Managed a budget of $1M annually. Implemented a computerized data capture dashboard system across multiple departments, decreasing errors and preparation time for formulation data. Generated $5M in revenue over 18 months by enabling studies with DEA Schedule 1 compounds. Updated security measures, storage procedures, and developed a DEA-compliant Schedule I management protocol.
Directed daily operations of the formulations department, overseeing 14 research associates, technicians, and lab assistants. Acted as Subject Matter Expert (SME) for Environmental Health and Safety, DEA Compliance, Import/Export of Materials, preclinical formulations, and operational processes. Evaluated studies, developed protocols, and prepared formulations to support outcomes for major pharmaceutical clients as well as emerging biotechnology and agricultural companies. Maintained comprehensive documentation, prepared technical reports, and provided laboratory support across the site. Managed an annual budget of $1M. Revitalized multiple formulations departments by implementing a computerized data capture dashboard system across the global enterprise, leading to error reduction and more efficient formulation data collection and preparation. Drove $5M in revenue within 18 months through the addition of capability to conduct studies with DEA Schedule I compounds. Redesigned security procedures, storage, and management protocols for Schedule I substances. Selected for a newly established role to lead the implementation of a global computer system for capture formulation data. Led a team of ten in executing enterprise-wide change initiatives, optimizing performance across six drug safety assessment sites in the US, Canada, and the UK. Supported laboratory operations in Horsham, PA, improving business processes and collaborating effectively with supervisors, technicians, and department managers. Successfully rolled out Capital Formulation Data systems enterprise-wide, resulting in reduced deviations and errors, and enhanced labor utilization from 60% to 80% within two years. Rebuilt infrastructure for enterprise formulation preparation, facilitating the adoption of new SOPs, processes, and KPIs.
Held dual role (2006–2012): managed lab operations and a 20-person staff at two sites and directed operations for seven global labs. Standardized procedures and data collection across all sites, coordinated technology transfers, and implemented new lab protocols. This standardization supported operations at seven locations and contributed to one of Sanofi’s successful NDA amendment submissions. Received the President’s Award for exemplary contribution.