Bioprocessing Engineering and Polymeric Biomaterials Expert
Technical Consultant #2357
- Biomolecular and bioprocessing engineering in the tissue-cell culture processing, polymeric biomaterials, surface chemistry, and medical industries.
- Skin care, biosensors, biologics, and regenerative medicine.
- Cancer immunotherapy-suspension cell culture in bioreactors, including review of iCELLis and wave technologies.
- CAPA Investigator and Coach for Root Cause Analysis.
- QbD Process Development Scientist (PAT, DOE).
- Quality Compliance Auditor.
- Upstream and downstream biologics GMP manufacturing.
- Drug delivery systems.
- Biomaterials, Biosensors, Bioreactors, and Bioprocess engineering.
- Cell culture.
- Medical devices (and combination therapies).
- Diagnostics (ELISA and DNA based).
- Regenerative medicine
- Skin care.
- Stem cells.
- Transdermal Delivery.
- Surface chemistry.
- Technology transfer.
- Bioprocess engineering.
Undisclosed Company, Consultant and Formulation Scientist, 2014 - Present
- Instructor for CAPA investigators and authored training materials for CAPA investigators, including a two-sided training "card" for quality-compliant root cause investigations.
- Compiled non-conformance data into pivot tables for multi-dimensional understanding of root cause trends.
- Advised clients in cancer immunotherapy space on suspension cell culture in bioreactors, including review of iCELLis and wave technologies.
- Invented a transdermal delivery nanotechnology for skin care products that delivers 250% more hyaluronic acid through skin than the competition.
- Developed surface coatings for implantable biosensors that improved enzyme activity by 50%.
- Produced proprietary biomaterials for stem cell binding and growth.
- Designed conjugation schemes and formulations for ELISA-based diagnostic device.
Shire Regenerative Medicine, San Diego, CA, 2012 - 2014
Research Scientist - Manufacturing Process Development
- Led team on DOE laboratory studies of a fibroblast cell therapy manufacturing process that involved bag bioreactors.
- Investigated critical process parameters, such as feed composition, feed timing, growth time, mechanical agitation, and seeding concentration on 2-D and 3-D mammalian tissue cultures.
- Planned studies executed, and analyzed with a Quality-by-Design method.
- By evaluating cell attachment, cell growth, and cell activity, we identified improvements in the tissue culture process that decreased the required growth time from 11 days to 7 days.
- This four-day improvement would have resulted in a 36.4% increase in manufacturing capacity.
- Completed weekly reports and presented data at monthly scientific town-hall meetings.
Baxter Healthcare Corporation, Los Angeles, CA, 2011 - 2012
Principal Engineer-Technical Services
- Technical liaison to manufacturing, quality, and planning departments for fully automated and manual plasma fractionation facilities.
- Trained as a "CAPA Lead Investigator" - supported CAPA and Non-Conformance (NCR/NCMR) investigations as the subject matter expert (SME) for the plasma fractionation process.
- Investigated process deviations, equipment failures, and downstream customer complaints to assess root causes and determine corrective actions.
- Completed hundreds of product impact statements for investigations and FDA audits.
- Became lead CAPA investigator for downstream filter failures.
- By analyzing data from hundreds of batches using Minitab, identified the root cause as shortened product incubation times during manufacturing. Findings: Batches incubated for less than 9 hours led to filter clogging, while batches incubated for greater than 14 hours did not clog the filter.
- Recommended to the team that to maintain incubation times above 14 hours.
- Corrective action was successful in reducing filter failures.
University of California, Los Angeles, CA, 2006 - 2011
Graduate Student Researcher - Department of Chemical and Biomolecular Engineering
- Completed doctoral thesis on the effect of growth factor presentation on cell signaling.
- Designed, built, and analyzed novel nanotechnology products to study growth factor binding and the effect of the binding on endothelial cell signaling.
- Demonstrated that VEGF incorporation into biomaterials can be engineered to stimulate structured blood vessel formation in tissue implants.
- Published 4 research articles in biomaterials-based journals and taught 5 graduate level courses (Biotechnology Lab, Bioseparations, Biochemical Reaction Engineering, Biotech Business for MBAs, and Project Management for UCLA Engineering Master's Online Program).
Amgen, Thousand Oaks, CA, 2006 - 2009
Intern in Process Development and Molecular Biology Groups
- Performed filter clogging studies (maximum pressure tests) on monoclonal antibody products with a DOE format investigating time, temperature, concentration, and mixing of ultrafiltration and diafiltration and tangential flow filtration systems.
- Showed that excessive manufacturing hold times increased the rate of protein aggregation.
- Designed and performed tissue culture experiments to determine the potency of a monoclonal antibody product on cancer.
- Used siRNA to trigger a cancer phenotype in the cells, and then titrated in an IGF-1 antibody to study its effect on cancer cell growth.
Honors & Publications
Academic and Professional Affiliations
- American Institute of Chemical Engineers
- NIH Biotech Training Grant
- Dissertation Year Fellowship
- Jonsson Comprehensive Cancer Center Grant
- Author and Co-Author of numerous publications in peer reviewed journals, abstracts, and educational text.
- Ph.D. Chemical Engineering, University of California, Los Angeles, CA
- B.S. Chemical Engineering, (Summa Cum Laude) University of California, Los Angeles, CA