Responsible for generation of autologous cell therapy product for Phase 3 Clinical Trials

Formerly Twin City Bio, LLCResponsible for overseeing activities related to processes and product development for company programs.Accountabilities Include: -Identifying and establishing Process and Product Development in the area of cell therapy and regenerative medicine -Leading efforts towards development of processes for the production of GMP materials for clinical studies and commercial production -Participating in the development of quality and manufacturing specifications for GLP/GMP

Biomedical Consulting Services:Biodegradable and Implantable PolymersMedical DevicesRegenerative MedicineTissue EngineeringDevice DesignProcess ResearchProduct DevelopmentTranslating proof of concept ideas to manufacturable productsDrafting and compiling regulatory submissionsDrafting SOP, Batch Records, Quality documents (GLP, GMP)Selecting vendors/qualifying raw materialsValidation

Led 9-member Process Development Team within the Regenerative Medicine Clinical Center to bring multiple projects from Proof-of-Concept through GLP studies, FDA submission, and into Clinical Trials. Projects included tissue engineered cell-scaffold constructs (natural and synthetic biomaterials and 3D printing), stem cell banks, and material-only products based on decellularized tissues.Accountabilities Included:-Producing test articles for definitive GLP studies-Process development for human products, including assay development, material sourcing, instrument identification and qualification, bioreactor design and fabrication, identification and coordination of outside vendors and testing-Drafting CMC sections of regulatory submissions-Guiding and developing in-process testing, lot release testing, potency testing (when applicable) and analytical testing-Generating Standard Operating Procedures and Batch Records for Phase I and II human clinical manufacturing-Coordinating with Manufacturing and Quality groups to ensure smooth technology transfer-Supporting Manufacturing group through early clinical manufacturingKey Contributions:• Successful filing of 3 IND and 1 Pre-IND applications• Delivery of progress, technical, and quarterly reports to management and PIs• Advancement of 10 Tissue Engineered Organ programs toward clinic

Scientist, 2005-2006Senior Scientist, 2006-2012Director 2012-2014Responsible for identifying, evaluating, optimizing, and characterizing resorbable biomaterials for implantation for Regenerative Medicine applications.Responsible for interfacing with professionals across various disciplines, including all levels of management, advisory boards, experts in the field, engineers, surgeons, cell biologists, vendors, and contractors.• Led team to bring implantable biomaterials from early stage investigations through GLP studies to human clinical trials• Spearheaded innovative efforts involving novel scaffold fabrication techniques• Proactively addressed biological, regulatory, and manufacturing concerns associated with the development of natural and synthetic implantable bioresorbable materials• Successfully developed, as well as oversaw the seamless addition of, innovative technology in order to facilitate the rapidly changing technological needs of the company• Responsible for the engineering aspect of bioreactor design and development • Prepared and submitted patent filings and various scientific communications documenting the development of techniques and technology • Successfully developed a specialized shipping apparatus designed to maintain clinical grade products at a specified temperature by utilizing phase changing materials in a passive system, sans electrical or mechanical means, in order to fulfill end user requirements• Developed strong collaborative relationships with vendors in order to translate product development needs into the production of GMP materials designed to meet project-specific needs• Interfaced with surgeons and OR staff in order to identify design constraints• Interactively engaged with staff, as well senior management and advisory boards • Co-authored regulatory documents successfully submitted to and approved by both US and European regulatory agencies, as well as several patents and scientific publications