Associate Director - Tech Transfer - Parenteral ExM

• Manage a team of scientists in a Process Characterization laboratory group responsible for commercial lifecycle drug product support• Matrix team leader accountable for all drug product activities for a commercial biologic product; including drug product processes, regulatory filings, health authority responses, PAI, general inspections and investigation support• Drug product technology transfer lead • Collaborate with matrix team members to streamline business processes • Identify process robustness risks, develop monitoring plans, risk mitigation strategies and drive implementation

• Optimized a lyophilization cycle to reduce overall cycle time by 20%• Provide lyophilization expertise to a cross-functional team including R&D and manufacturing• Coordinate with R&D and manufacturing groups to support product robustness, investigations and new technology implementation• Proficient with statistical analysis tools including Minitab and JMP• Developed filtration scale down models to facilitate process improvements and technology transfers

• Recipient of Superlative Service Award for outstanding client satisfaction• In charge of planning and executing multiple projects simultaneously• Method development for batch processing including thawing, dispensing, and sampling improvements• Lab scale lyophilization cycle development and cycle refinement• Operate and program lyophilizers• Differential Scanning Calorimetry – method development and sample analysis (TA Instruments Discovery Series and Q Series)• Freeze Drying Microscopy – method development and sample analysis• Karl Fischer – residual moisture testing of lyophilized products and procedure improvements• Live virus handling using biological safety cabinets• Track and submit samples using LIMS• Complete experiments utilizing electronic laboratory notebook• Create electronic notebook templates for repeatability and standardization of experiments

• Follow current Good Manufacturing Practices while processing sterile drug product• Write, revise, and follow Standard Operating Procedures• Write, revise and follow batch records• Write and revise batch summary reports• Formulate, filter, and fill products in Class 100 clean rooms• Work aseptically in Clinical Manufacturing Area• Perform formulation research and refinement• Operate manual and automated filling equipment• Operate and program freeze drying equipment• Operate analytical instruments: Karl Fischer, DSC, TGA, pH meter, osmometer, turbidity meter, UV spectrophotometer, Freeze Drying Microscope• Order and implement new laboratory equipment and instruments• Maintain laboratories, equipment, instruments and supplies• Perform Validation and Qualification of procedures and equipment.• Lyophilization experience with variety of pharmaceuticals including oncolytics, antibiotics, liposomes, proteins, amino acids and organic solvents