Mai Anh Do, Stanford

Experienced cGMP cell therapy specialist with a demonstrated history of working in the healthcare biotech. Skilled in Gene Therapy, Phase I/II Clinical Trials, CAR-T, Tech Transfer, and Data Analysis. Strong process development and GMP manufacturing professional with a Master of Science (MS) focused in Bioengineering and Biomedical Engineering. 5 years of total experience in the field.

Experience

Stanford Medicine

2018 – Present

Associate Scientist, GMP Process Development

CAR-T process development and tech transfer at Stanford Cancer Institute, Center for Cancer Cell Therapy.

  • Led technology transfer from PD lab to cGMP site
  • Led development activities for first-in human CAR-T clinical trial processes
  • Developed batch records, SOPs, RMSs, WIs
  • Performed multicolor flow cytometry and utilized Cytoflex, BD Fortessa, FACSDiva, FlowJo, GraphPad
  • Trained new hires

Clinical Process Development and Manufacturing Professional II

Process development and manufacturing cell therapeutics in cGMP environment for Phase I/II cancer clinical trials at the Laboratory for Cell and Gene Medicine.

  • Specialized in manufacturing CAR-T cell therapeutics for cancer clinical trials in cGMP cleanrooms at the Laboratory for Cell and Gene Medicine (LCGM)
  • Led manufacturing campaigns independently as operator, verifier, and trainer
  • Utilized cell processing platforms (Prodigy, LOVO, CliniMACS Plus) and cell analysis instruments (MOXI Flow, Sysmex, Cellometer)
  • Designed and performed complex components for optimization/troubleshooting
  • Identified operating excursions and deficiencies during manufacturing, determined deviations, revised batch records, SOPs, and work instructions
  • Initiated CAPAs, and drove Change Controls
  • Led weekly meetings, analyzed and presented manufacturing results

Santa Clara University

2016 – 2018

Laboratory Manager

  • Implemented bioengineering laboratory policies (aseptic cell culture training, equipment training, safety training)
  • Managed inventory, developed SOPs, oversaw undergraduate students, coordinated with PI

Skills

  • cGMP
  • Cell and Gene Therapy
  • Tech Transfer
  • Clinical Trials
  • Cell Therapy Manufacturing
  • Bioengineering

Education

MS, Bioengineering and Biomedical Engineering, GPA 3.90

BS, Biochemistry, GPA 3.95

Patent

Engineered Exosomes for the Delivery of Bioactive Cargo Using Transmembrane VSV-G B Lu, D Levy, MA Do, US Patent 16/900,3832020

Selected Publications

Google Scholar

Targeted delivery of lysosomal enzymes to the endocytic compartment in human cells using engineered extracellular vesicles MA Do, D Levy, A Brown, G Marriott, B Lu, Nature, Scientific reports 9 (1), 1-11102019

Decoy exosomes as a novel biologic reagent to antagonize inflammation N Duong, K Curley, A Brown, A Campanelli, MA Do, D Levy, A Tantry, International Journal of Nanomedicine 14, 3413172019

Sequential deletion of CD63 identifies topologically distinct scaffolds for surface engineering of exosomes in living human cells N Curley, D Levy, MA Do, A Brown, Z Stickney, G Marriott, B Lu, Nanoscale Journal 12 (22), 12014-1202632020

Personal

Mai is married, has a baby girl Emily, and 2 shiba inu puppies Becky and Pocky.

Together with her husband David, they recently started a foundation to help international students through providing scholarships and mentorship. Read more about Mai Anh Do & David Nguyen Foundation at https://maidavid.org

Contact

Email: maianhcz@gmail.com

LinkedIn: https://www.linkedin.com/in/maianhdo/