• Management of validation and product transfer consulting projects for pharmaceutical, biotech and device companies including: Allergan, Introgen Therapeutics, B|Braun, Medtronics, Johnson & Johnson, Cephalon, Guidant, and Isis Pharmaceuticals, Boston Scientifc• Managed the product transfer, validation, and scale up of manufacturing processes for clinical, biotech, and IVD chemistries, as well as tablet operations• Planned and managed process validation and test method validation of liquid, solid dose, powder and lyophilyte, as well as separations chemical compounding processes• Developed, characterized, transferred, validated and scaled up instrument manufacturing processes• Defined and directed projects for manufacturing Equipment IQ, OQ, PQ, test method validation, process validation, software validation, vendor qualification, and process/product improvements• Defined and implemented MPS (master production scheduling), CRP (capacity requirements planning), and MRP (material requirements planning)• Consultant for product development and transfer projects• Provided support for regulatory submissions• Created and implemented design control process for integrated test systems• Experienced in the selection and qualification of vendor partners• Skilled in the utilization of DOE (Design of Experiment), SPC (Statistical Process Control), and SQC (Statistical Quality Control)• Experienced in the usage of FMEA (Failure Mode Effects Analysis), FMECA (Failure Mode Effects and Cause Analysis) FTA (Fault Tree Analysis), hazard analysis and risk analysis techniques• Accomplished in the employment of cGMP, design control and validation in medical device, Biotech, IVD, or pharmaceutical applications• Proficient in the use of Six Sigma and other approaches to total quality management (TQM)Specialties: Manufacturing product development, transfer, validation and scale-up