Manage all aspects of stability program for bulk Active Pharmaceutical Ingredients (API) and high purity, low endotoxin carbohydrate excipients.

• Lead analytical role in methods development and ICH validation of HPLC assay/impurities, HPLC-MS, GC residual solvents, wet chemistry, activities in support of contract manufacturing for numerous potent bulk Active Pharmaceutical Ingredient’s. Including analytical activities in support of process development and process improvement • Manage test method upgrades including full validation and all related analytical activities in support of high purity, low endotoxin carbohydrate product line including trehalose, maltose, galactose, mannitol , ribose and 2-deoxyglucose used in a variety of pharmaceutical applications• Lead analytical responsibility on numerous teams tasked with new product development and improvements to existing manufacturing processes • Ferro Corporation excellence in manufacturing team award 2009 – lead analytical team member • Industrial hygiene method development and validation for air sampling of potent compounds in support of manufacturing operations• Established microscopy laboratory, conduct investigations to support plant manufacturing processes and QA customer complaints and inquiries• Creation and execution of numerous validation protocols for HPLC assay and impurity test methods, GC residual solvents, wet chemistry, Karl Fisher (volumetric and coulometric) protocols, contract customer transfer protocols and subsequent reports• Marketing support for high purity low endotoxin sugars, novel investigation of unique qualities• Manage maintenance and annual performance of calibration of all HPLC and GC instruments for QC/MDV labs

• Responsible for development and validation of HPLC and GC test methods utilized for finished product release, in-process and stability testing. Products ranged from potent anticancer active pharmaceutical ingredients to high purity low endotoxin sugars used as pharmaceutical excipients• Creation of standard operating procedures for HPLC and GC product release testing, finished product and stability specifications• Manage stability program for bulk Active Pharmaceutical Ingredients • Evaluation of available stability packages and implementation of stability software system• Responsible for training QC lab personnel on HPLC and GC test methods• Manage laboratory instrument calibration program, including creation of standard operating procedures and calibration acceptance criteria for instrumentation• Oversee contract laboratories conducting methods development, validation and testing activities