Launching a new CDMO capability within AmplifyBio for Clinical and Commercial manufacturing in Cell and Gene Therapy.

Scientific advisor and board member

Member of Site Leadership team that oversaw daily operation of manufacturing facility and R&D/Development facility.• Led quality compliance, quality operations, and document control groups within quality assurance.• Developed quality assurance team to assure excellence in phase III clinical product FCR001 – cell therapy to develop immune tolerance in patients receiving a kidney transplant and phase I and II effort to treat Scleroderma.• Enabled pathway for follow-on therapies to leverage lead clinical product.• Improved documentation and technical writing both in the development of procedures and validation protocols as well as in investigations associated with deviations, lab investigations, CAPAs, and change controls.• Provided technical and quality leadership for the qualification and validation of process and analytical development.• Developed and executed a detailed project plan to reach full GMP compliance prior to submission of a BLA.• Led the transition of paper-based systems to an electronic QMS approach utilizing Veeva.

• Serve as PI on various Governmental and Commercial contracts and grants.• Participate on business development team to help direct research and grant writing efforts.• Serve as expert technical collaborator for internal projects.• Interface with external scientific and technical community on behalf of company.• Develop and expand funded research programs within the company.

• Established a GMP/GTP cleanroom cell-based manufacturing suite. Oversaw construction and commissioning of the suite then coordinated the development of a Quality System approach toregulatory compliance. Served as the Quality Assurance and Regulatory Officer for all cleanroom activities.• Designed and developed electrospinning apparatus to create vascular conduits from natural proteins and synthetic polymer nanofibers.• Oversaw a team to develop in vitro blood vessel model using electrospun conduits.• Co-developed Adipose-Derived Stromal Cell (ADSC) specific digestion solutions for clinical and research applications.• Developed a fibrinogen-based electrospun scaffold that was combined with ADSCs to close ano-rectal fistula tracks resulting from Crohn’s Disease. Led the team that conducted preclinical animal trials that ultimately received IRB approval to begin a pilot clinical trial. This data was used to support an IND application for a multicenter Phase I trial.• Developed strategic partnerships with outside groups to supply materials and co-brand the resultingproduct. Led licensing discussions with a major manufacturing to carry the product forward through late phase clinical trials and commercialization.• Developed a living vascular conduit as part of a 10-year Institute-wide interdisciplinary program to develop a tissue-based replacement heart termed the Bioficial heart Program. Collaborated with other groups to lend expertise in scaffold design, material testing and cell isolation.

-Oversee all biological testing, analysis and development of vascular projects-Manage technical staff-Assist in the coordination of regulatory efforts-Provide general expertise in tissue engineering and regenerative medicine-Evaluate cell therapeutic opportunities for adipose derived stromal cells

Performed contract research in the areas of biomaterials and tissue engineering - specific applications in tissue decellularization, allografts and bioreactors.

Responsible for daily process functions in laboratory operation. Direct supervision of all process changes and improvements in the bioprosthetics laboratory which included the technology transfer from R&D to develop pilot manufacturing of a tissue engineered heart valve and a composite porcine prosthetic heart valve.

Managed the Advanced Research evaluation laboratory, which was responsible for the development of physiologically significant in vitro test method for cardiovascular devices. Served as technical advisor on various FDA 483 response teams and for the New Business Development and Marketing departments.

Served as the principal engineer in the R&D Engineering Test Lab. Responsibilities included design and improvement of heart valve testing, coordinating hydrodynamic testing for regulatory submissions of new devices, automation of tissue processing systems and mechanical characterization of heart valve tissue after chemical treatments.