• Manage long term and day to day needs of REFI faculty, staff, and students• Develop programs to promote faculty engagement and collaboration to catalyze translational medicine• Lead MPower Entrepreneurship Fellows program• Mentor MPower Entrepreneurship Fellows in the development of their medical device• Provide regulatory and industrial guidance for medical device companies and innovators• Teach classes on medical device development and commercialization

Provide biomedical engineering consulting services for companies and new investors. These services include: • cGMP/GTP manufacturing GMP/GTP manufacturing scale up SOP writing Process troubleshooting Contamination monitoring, analysis and remediation ISO, ASTM, EU, FDA standard analysis • Optimization of Manufacturing / Process Design Process and equipment design Process improvement Process mapping Move and set up of new facilities Development of new hire training programs• Quality Assurance Quality System Implementation Compliance Gap Assessments Validation Report Review Process Audits • Protocol development ISO 10993 biocompatibility testing In vivo studies Aseptic technique Mammalian cell culture Safety Polymer characterization• Data analysis Statistical analysis• Study Design Study justification Animal models

Funded by a Center for Education Regulatory Science and Innovation (CERSI) Project within the Center for Device and Radiological Health (CDRH). • Characterized porous tissue engineering scaffolds using micro computed tomography, mechanical compression testing• Wrote Image Processing Language (IPL) code to evaluate the scaffold properties during degradation• Investigated standard development for biodegradable tissue engineering products

Ann G. Wylie Fellow• Investigated the use of 3D printing for the fabrication of degradable scaffolds to treat bone defects• Developed methods to characterize and evaluate 3D printed products• Developed toxicity assays to determine cytotoxicity of a degradable polymer• Synthesized, analyzed, and characterized the polymer poly(propylene fumarate)• Optimized perfusion bioreactor for human mesenchymal stem cell culture

• Worked with team to develop production methods for novel MSC-based product • Audited and revised quality control assay procedures for compliance with cGMP requirements• Authored SOPs for review of GMP data, aseptic technique, and safety

• Managed day to day operations of Osteocel, staff of 50+ team members• Facilitated due diligence requests during department acquisition• Revised manufacturing process to increase production by 50% to achieve 83% sales growth to $15.2MM in 2007• Responsible for reports and protocols for cGTP/cGMP operations • Orchestrated move to and set up of new manufacturing facility• Developed and implemented training plan, reducing time to efficacy for new hires• Improved first time quality, manufacturing output, and reduced deviations through training and incentive plans • Received annual capstone award "Execution" (2007) for facilitating Osteocel production growth

• Compiled data for annual reports and somatic cell submissions to the FDA• Developed and implemented technology transfers• Ensured achievement of Osteocel financial goals • Provided metrics including analytical and financial reports for the executive board

• Followed SOPs and BPRs in accordance with cGTP• Recorded operations in production records, logbooks and controlled documents

• Led multidisciplinary teams to over $4MM in manufacturing equipment procurements• Developed equipment specifications and purchases for new manufacturing lines• Responsible as the liaison between the marketing and manufacturing departments during the development of new products and revisions of existing SKUs.• Negotiated the pricing for labels, shipping boxes, package inserts, gloves, accessory kits, and product packaging