• Project manager for advancing the understanding of kidney disease states in living kidney donation with subsequent exposure to toxic drugs.• Assured quality by being lead in SOP development, document and record keeping, equipment validation, internal knowledge transfer and reporting adverse events of test-subjects with targeted drug. • Controlled quality of high-throughput data through standardization of data entry and data cleaning.• Implemented randomized pre-clinical trials, in vivo (GLP) testing acute, chronic, and sub-chronic toxicity of living subjects exposed to chemotherapy agents. Additional studies using biomarkers were used as measurable indicators of chronic kidney disease.• Identified patterns through biostatistical analysis of data from two case-control epidemiological studies in living subjects (tens of thousands of data points) • Published and wrote research and medical papers, posters, oral presentations, and seminars, with accuracy, clarity, and consistency.

• Subject matter expert in developing permanent contact lenses made from Human tissue, from proof-of-concept (POV) to cGMP manufacturing.• Process optimization reducing costs by 70% due to yield improvement of cornea tissue.• Knowledge and tech-transfer by coordinating Supply Chain, QA, Analytics, and Manufacturing for process production planning.• Supported clinical data management from Phase I clinical trials by providing visualization and statistical analysis in form of reports for regulatory submissions.• Manager of biologics department, fostering and maintaining good cGLP practices within R&D, responsible to ensure that the aseptic products are produced in a timely and safe manner meeting all specifications, quality standards, FDA regulations, and other Health Authority guidelines.• Designer and process reviewer of lifecycle documents (IQ, OQ, and PQ) external knowledge transfer to production facility (GMP/GDP) and clinical trial sites (nurses/surgeons).• Supported validation of equipment and processes in accordance with cGMP requirements.

• Lab manager (inventory management, supply chain coordinator).• Controlled hydration process in lens manufacturing process by chemical and physical processes.• Developed prototypes (CAD/Solid Works) to increase yield and reduce costs by 70%.• Procurement and assembly of the surgical kit required for the surgical implantation of the tissue-based lenses.• Development of own verififcation protocol for controlling the tickness of Human fresh-tissue involved in lens manufacturing.• Holistic data review for production root cause analysis.

Development of a biosynthetic skin for patients with severe burns through electrospinning of PCL and Chitosan.Development of drug-loaded oral films for cancer patients with dry mouth syndrome by electrospinning, solid casting, phase-inversion supercritical carbon-dioxide membrane casting, and freeze-drying techniques.Major accomplishments:• Bioreactor production of bacterial polymer.• Dendrimer encapsulation of hydrophobic drug for prolonged drug release.• Biocompatibility and cytotoxic studies using VERO cells.

Development of a biosynthetic second skin, engineered to treat severe burns, by means of electrospinning technique to meld natural and synthetic polymers.