CAPA - QbD Expert and Scientist for Life Science GMP Industry

Technical Consultant #2357


Expertise

  • 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.

Specific Services

  • CAPA Investigator and Coach for Root Cause Analysis.
  • QbD Process Development Scientist (PAT, DOE).
  • Subject matter expert for life science related technologies and manufacturing processes.
  • Quality Compliance Auditor.
  • Upstream and downstream biologics GMP manufacturing.
  • Drug delivery systems.
  • Nanotechnology.
  • Biomaterials.
  • Bioreactors.
  • Cell culture.
  • Bioconjugation.
  • Biosensors.
  • Medical devices (and combination therapies).
  • Diagnostics (ELISA and DNA based).
  • Regenerative medicine
  • Skin care.
  • Stem cells.
  • Transdermal Delivery.
  • Hydrogels.
  • Surface chemistry.
  • Technology transfer.
  • Bioprocess engineering.

Experience

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

Awards

  • NIH Biotech Training Grant
  • Dissertation Year Fellowship
  • Jonsson Comprehensive Cancer Center Grant

Publications

  • Author and Co-Author of numerous publications in peer reviewed journals, abstracts, and educational text.

Education

  • Ph.D. Chemical Engineering, University of California, Los Angeles, CA
  • B.S. Chemical Engineering, (Summa Cum Laude) University of California, Los Angeles, CA
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