Lead and oversee CMC functions for CiRC Biosciences, including Process Development, Analytical Development, and Quality. Develop and execute the hiring strategy to build the CMC group; manage and mentor that team of 7 scientists, engineers, and quality professionals. Provide technical and strategic leadership and program management for CMC development of CiRC’s cellular therapeutics. Oversee external partnerships with CDMO and CRO. Prepare CMC sections for FDA submissions.

Led company biomedical engineering activities and nonclinical/preclinical development of regenerative medicine pipeline. Provided technical leadership and project management to interdisciplinary R&D and process development projects focused on improvement of regenerative medicine products. Managed and mentored a research team of scientists and engineers. Directed engineering/R&D support to matrixed interdepartmental efforts. Prepare reports for internal and external stakeholders. Project management of a $250M BARDA contract for approval and commercialization of StrataGraft skin tissue. Prepared CMC sections for FDA submissions (IND amendments, BLA). Developed regenerative medicine R&D strategy and technical due diligence of BD&L opportunities.

Led company biomedical engineering activities and nonclinical/preclinical development of regenerative medicine pipeline. Provided technical leadership and project management to interdisciplinary R&D and process development projects focused on improvement of regenerative medicine products. Managed and mentored a research team of scientists and engineers. Directed engineering/R&D support to matrixed interdepartmental efforts. Prepare reports for internal and external stakeholders. Project management of a $250M BARDA contract for approval and commercialization of StrataGraft skin tissue. Prepared CMC sections for FDA submissions (IND amendments, BLA). Development of product concepts, R&D strategy, and technical due diligence of BD&L opportunities.

Led company biomedical engineering activities and nonclinical/preclinical development of regenerative medicine pipeline. Provided technical leadership and project management to interdisciplinary R&D and process development projects focused on improvement of regenerative medicine products. Managed and mentored a research team of scientists and engineers. Served as technical lead on a $50M BARDA contract focused on late-stage CMC development of StrataGraft skin tissue; led a team of ~8 technical personnel and coordinated CMC development with manufacturing, clinical, quality, and regulatory. Directed engineering/R&D support to matrixed interdepartmental efforts. Prepare reports for internal and external stakeholders. Prepared CMC sections for FDA submissions (IND amendments, BLA). Primary author of a proposal awarded a $250M BARDA contract for the approval and commercialization of Stratatech skin tissue. Development of product concepts, R&D strategy, and technical due diligence of BD&L opportunities.

Provided technical leadership and project management to interdisciplinary R&D and process development projects focused on improvement of regenerative medicine products. Prepared reports for internal and external stakeholders. Prepared CMC sections for FDA submissions (IND amendments, BLA). Led planning, writing, and management (as PI or technical lead) of multiple government grants and contracts (including NIH, NSF, DOD, and BARDA). Served as technical lead for a $50M BARDA contract focused on late-stage development (Phase II into Phase III) of StrataGraft skin tissue. Collaborated on R&D strategy and helped define new product concepts.

Performed PhD research in the Cartilage Tissue Engineering lab, under Dr. Robert Sah. Investigated the biomechanical factors in cartilage degeneration and repair.