Seasoned Global GMP Expert

Highly motivated and accomplished Quality & Manufacturing processional with over 25 years in the industry with proven experience in global quality (QA/QC), product quality management, quality systems, regulatory/quality compliance, process/product development (upstream, downstream, and fill/finish), technology transfer, continuous process/product improvement, validation, and licensing of biopharmaceuticals, vaccines, medical devices and diagnostics in the field of cancer, multiple sclerosis, haemophilia, thrombosis, infectious diseases, enzyme replacement therapy, wound healing, and drug delivery.

Product Technologies

  • Combination Product
  • Drug
  • Drug Delivery
  • Small Molecule
  • Vaccines

Relevant Therapeutic Areas

  • Oncology
  • Infectious Diseases
  • CNS
  • Hematology

Recent Titles

  • Vice President, Quality & Regulatory Operations
  • Scientist, Corporate Quality
  • Manager, Process Validation


  • San Francisco Bay Area
  • Open to remote and in-office

Relevant Companies

  • Bayer
  • Genzyme
  • Small Biotechs

Skills & Accomplishments

  • Participated in 7 NDAs, 3 sNDAs, and more than 10 INDs.
  • Clinical trial physician on studies conducted in US, Europe, Japan, Latin America and South Africa.
  • Accountable for recruiting of investigators, authoring of clinical sections of key documents, as well as providing scientific and medical expertise to the development team