Lead technical operations including manufacturing, technical development, supply chain, quality, and CMC operations.

Development roadmap to enable product commercialization, enable manufacturing capability for clinical supply, and ensure supply chain delivery. Responsible for quality oversight for all GCP, GLP, and GMP activities.

Enable analytical, formulation, and process development along with lab services and vector core research and development. Supported the buildout and design of a new GMP pilot plant and laboratory space for Quality Control and all development functions within technical operations. Set-up and led CMC governance to enable product commercialization.

Build an Analytical Method Development, Quality Control and Lab Services unit within Technical Operations. Enable the development of a late phase readiness plan and support the development of a governance plan for clinical production and future commercialization.

Participate in the design and build-out of a 60,000 square foot facility expansion that was awarded a FOYA 2018 honorable mention. Support QC and Manufacturing, transfer methods across sites, and develop new methods to support internal products, partners, and clients. Support the business development function with technical support and lead project teams to support Emergent partnerships. Technical lead for team that won the first CEPI grant.

Implement quality control systems to support facility validation, method transfer and validation, and production of clinical material to support clinical and commercial production. Support facility readiness for commercial production and future build out in support of BARDA contract.

Developed enhanced QC program supporting on site and off site product testing. Initiated ASAT support for the site. Implemented LIMS at the site.

Participated in the design and building of a 130,000 square foot pilot plant for the manufacture of biologics and vaccines. Built analytical development and quality control departments to develop methods and built release quality systems for vaccines, plasmid DNA, viral vectors, proteins, antibodies, VLPs and nanoparticles. Manage multiple functions with groups of over 40 and secondary responsibility for over 120.

Implement assay validation, process validation, and analytical testing plans according to the master validation plan and ICH and FDA guidelines.Set and attain short and long term QC and AD goals, including support of IND and BLA submissions, commercialization, and client/collaborator milestones.Support and implement contract manufacturing work.Develop new formulations, processes, and analytical methods.Participate in the development, design, and construction of a 68,000 square foot research, development and manufacturing facility.On team that developed and implemented a small fill facility.Support development of Gene therapy technology using cationic lipid and polymer carriers.Support product development of naked DNA technology.Support development of proDrugs for oncology applications. Establish and manage proactive GMP-compliant QC program.

Developed raw material program, environmental monitoring program; ran validation, performed analytical and process development.

Develop operational plan for analytical and process development, manufacturing and quality operations, and outsourcing strategy to support early stage product development. Support founders in obtaining and developing a business plan, venture capital, and laboratory space.

Implemented Biosafety, Chemical Hygiene and Radiological Safety Programs. ran Materials Management, and performed product development.

Performed formulation development of lipid compexes and artificial virus particles. Ran IT support for the company. Performed product development of cationic lipid and plasmid DNA constructs.

Formulation development, product development and IT support.

Product Development on Non-viral Gene Therapy Agents plasmid DNA and RNA. demonstrated first use of RNA and pDNA for gene transfer in-vivo. developed leading cationic lipids that have supported the use of lipoplexes, polyplexes and lipid nanoparticles.

Manage client projects for contract research organization.Implement and validate clinical assays in support of PK, PD, ADME studies. Prepare project reports for human clinical studies using a variety of bioanalytical technologies.