Lead global innovation project teams. Successfully launched multiple new and improved product offerings. Led process improvement initiatives resulting in significant operating impacts. Implemented Project Best Practices at this multisite, international manufacturer. Supported development by implementing book club review and spear heading community based activities for local teams. Traveled to support teams domestically and internationally.Product Development and Launch, Life Cycle Management. Project Best Practices, Supplier Relationship Management, Computerized Inventory Systems, Material Planning and Sourcing, Operational Improvements.

Successfully led multinational, cross functional teams in support of cost reduction, product improvement and new product implementation projects.Medical Device, Regulatory approval, Clinical Supply, CPGs, Material Planning and Sourcing, External Manufacturer and Supplier Management, CAPA, SAP, MDD, MDR, EMC.

Led professional scientific testing teams to provide top notch support for client product development and regulatory testing requirements. Supervised Testing Team.Cross Functional Team Leadership, Customer Facing, Lean Leadership, Quality Control, Quality Assurance, CAPA, Root Cause Analysis, Business Data Analysis, Process Flow Charting and Optimization.

Provided project leadership and support to product launch teams as well as team efforts toward process and offering improvement and IT initiatives.2014 Ameritox CEO Award of Excellence.CAP, CLIA, Product Development and Launch, Cross Functional Team Leadership, Root Cause Analysis, Business Data Analysis, Process Flow Charting and Optimization, Feasibility Analysis.

Led cross functional transfer teams for movement of new products into manufacturing environment.Led production, engineering, quality, and warehouse teams in the manufacture and shipment of medical devices and consumables. Responsible for supervision of plant employees. Medical Device, Regulatory Approval, Contingency/Budget Planning, and Financial Controls/Projections, Technical writing, Materials Management and Distribution, Requirements analysis, Supply Chain Management, JIT, Process Flow Charting, Process Control Planning, SPC & Process Capability Analysis, Value Stream Mapping, Risk Assessment and Mitigation including FMEA, Kaizen, 5S, Set-up reduction, Standard Work, QDIP, Visual Management, Quality Control, Quality Assurance, CAPA, KPI identification and reporting, SDLC.

Led multidisciplinary product development teams to support new pharmaceutical development and delivery at this CDMO.Coordinated all aspects of 10-12 projects concurrently including initiation, risk assessment, design selection and oversight, budgeting, scheduling, regulatory and analytical activities, and general documentation of project progress. Development, tech transfer, manufacturing, analytical development experience. Supported client and FDA project related audits.Primary customer-facing contact for client projects in development.Drug Development (CMC), Solid dosage forms, Soft Gels, Generics, OTC, CDMO, Client Delivery Projects, Late Stage Development, Life Cycle Management, Microsoft Project, VOC, POC and Manufacturability Assessment, FDA, GMPs , PMI member, CMC, Risk Assessment, Timeline management. FDA, EMA, GMP, GCP, and ICH.

Managed multidisciplinary team for North and South American clients providing cycle times improved by more than 25% as opposed to those previously.Supervisory responsibility for US Sequencing Team employees.Member of ISO9001 certification team for MWG.Process implementation, General Project Stewardship, Budgeting and P&L Management, LIMs, SDLC, Laboratory Automation, Supplier Management, Client Facing Support.

Led team in design and implementation of Bio-informatics platform for assembly and storage of DNA Sequencing data. Administration of UNIX system for DNA analysis. Technology/system implementation, Perl programming, Unix administration. Phred, phrap, cross_match, consed, and the NCBI Blast dBs.

Led team performing large and small scale IP generating projects to bring this company from startup to successful IPO in less than three years.Planned company retreat events.General Project Stewardship, Process Improvement, Cost Reduction and Control, Bioinformatics, LIMs.

Implemented process improvement initiatives for high throughput platforms, increasing production output.