Tiffany Rau

Senior CMC Consultant

Expertise in CMC Manufacturing & Strategy in mammalian and microbial systems. Experienced in the production of biopharmaceutical products including Cell Therapies, mAbs, AAV & Lentivirus, therapeutic proteins and vaccines. Expertise in technology transfer, process scale-up, characterisation and validation (PPQ) as well as PAI readiness.

Skills:

  • Process development, manufacturing operations & CMC strategy.
  • Has established R&D activities & infrastructure in a manufacturing facility.
  • Manufacturing improvements at multiple manufacturing scales.
  • Technical experience for 3 commercial products & clinical programs.
  • Expertise in managing and working with global CDMOs.
  • Involved in regulatory filings for originator biologics & biosimilars. Development of small scale scalable bioreactor systems for mammalian cell culture.
  • Involved in international tech transfers and scale-ups .
  • Process Improvements/Optimization and process robustness. Expertise in QbD and Six Sigma Master Black belt.
Tiffany Rau
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contactus@greyrigge.com