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LLC Owner, Development QA - Biologics Early Phase GMP

Development QA - Biologics Early Phase GMP

Consulting for Biotech Quality Assurance Early Clinical Phase GMP
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Areas of Expertise

  • NJ, United States
  • English

About

Helping biologics start-ups oversee clincial supply GMP. These companies, whether virtual or in-house manufacturing, often have less experience with quality systems due to focus on scientific and technical discovery. Some promising start-ups are KO'd by faulty quality in clinical manufacture. Sometimes, contract manufacture relationships require more quality oversight.

Experience

LLC Owner
Development QA - Biologics Early Phase GMP

Medarex
Bristol Myers Squibb
Jonson & Johnson
Ortho Biotech

Education

PhD Immunobiology Cornell Weill Graduate School of Medical Sciences Sloan-Kettering Division 1982
BA Biology UC San Diego Revelle College High Honors 1973

Past Conversations