Process Development to Commercial Manufacturing, CMC Strategy, Biopharma & Industrial Proven experience in setting up development and manufacturing centers of excellence in a global environment. Providing guidance to your team - mentoring them, empowering them with the knowledge required, increasing their skill sets and thus enabling them to achieve their goals whilst providing rapid ROI for your organization.
Tiffany D Rau, Ph. D, owner and Principal Consultant of Rau Consulting is an expert in bio processing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing.
Dr. Rau has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges.
Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems
Proven experience in setting up development and manufacturing centers of excellence in a global environment.
Human health and animal health and the scientific and regulatory environment
Process development in industrial biotechnology.
Process robustness and reduction of variability ie Design for Manufacturing and DoE
Bioreactor development for microbial and mammalian cell culture.
Pilot plant design and management built to cGMP specifications- Projects greater than $6 million
Multiple biological products currently on market including the 1st Bio similar Insulin (Tech Transfer) and At Scale "Development" and commercial launch material
International process "development" consulting in bio pharmaceuticals, vaccines, and industrial biotechnology - Process Improvements/Optimization and process robustness.
Global scientific and business development/relationship management. Development and Integration of "new" technology into organizations. External Manufacturing and development management Improving product titers using small molecule additives while extending culture viability. Creation of well plate-based cell culture assays for increasing the speed of testing and evaluating in vitro cell cultures and conditions. Connecting MAb production enhancement to the biochemical network for specific productivity. Laboratory and IT project management International Project Management CMO Management
Experts and leaders in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of bio pharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) & industrial biotech
Bio Pharma Technical Consulting