Tiffany  Rau Phd

Tiffany Rau Phd Email and Phone Number

Process Development to Commercial Manufacturing, CMC, GMP, Biopharma, Cell and Gene Therapy, Facility Design and Start-up, CDMO selection and management, Quality Systems @ University College Cork
Tiffany Rau Phd's Location
United States, United States
Tiffany Rau Phd's Contact Details
About Tiffany Rau Phd

Expert and leader in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of biopharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) cell and gene therapy & industrial biotechProven experience in setting up development and manufacturing centers of excellence in a global environment.Expertise in human health and animal health and the scientific and regulatory environment Expertise in process development in industrial biotechnology.Bioreactor development for microbial and mammalian cell culture. Expertise in process robustness and reduction of variability ie Design for Manufacturing and DoEPilot plant design and management built to cGMP specifications- Projects greater than $6 millionMultiple biological products currently on market including the 1st Biosimilar Insulin (Tech Transfer and At Scale "Development"​ and commercial launch materialInternational process "development"​ consulting in biopharmaceuticals, 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 managementImproving 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 managementInternational Project ManagementCMO ManagementSpecialties: Technical management and Technical development. Process Development, Scale-up and Scale down, Technology Transfers, DoE, metabolic flux analysis, kinetic modeling, Bioreactor development, Six Sigma- Master Black belt, Global Expertise- Europe and Asia, Ecoli, Yeast, Streptomyces, CHO, Vero, Cell therapeutics/stem cells

Tiffany Rau Phd's Current Company Details
University College Cork

University College Cork

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Process Development to Commercial Manufacturing, CMC, GMP, Biopharma, Cell and Gene Therapy, Facility Design and Start-up, CDMO selection and management, Quality Systems
Tiffany Rau Phd Work Experience Details
  • University College Cork
    Adjunct Professor Biochemistry And Cell Biology
    University College Cork Jan 2024 - Present
    Cork, Ie
    Advanced Cell and Gene TherapyBiopharmaceuticals
  • Bio Pharma Technical Consulting
    Owner And Principal Consultant
    Bio Pharma Technical Consulting Feb 2022 - Present
    Consulting Team in the areas of Process Development, CMC, Tech Transfer, Process Characterisation, PPQ and Validation, CMC Strategy, Internal and External Manufacturing FDA and EMA interactions and guidance, 21CFR compliance, Biopharmaceutical, Large Molecule, Cell and Gene Therapy, Mammalian and Microbial Expression systems, Radiopharmaceuticals, Project and Program Management. Vendor Management - Supply Chain and CDMOs. Supplier Qualification Programs and Audits, Annex I, FDA and EMA readiness www.bptc.ie
  • Rau Consulting Llc - Biotech
    Owner And Principal Consultant
    Rau Consulting Llc - Biotech 2020 - Present
    www.raubiotech.comConsulting Team in the areas of Process Development, CMC, Tech Transfer, Process Characterization, PPQ and Validation, CMC Strategy, Internal and External Manufacturing FDA and EMA interactions and guidance, 21CFR compliance, Biopharmaceutical, Large Molecule, Cell and Gene Therapy, Mammalian and Microbial Expression Systems, Radiopharmaceuticals, Project and Program Management. Due Diligence Activites Quality Topics including SOPs, Deviations, Supplier Qualification, CAPA, etcGMP readiness; FDA and EMA readiness including PAI
  • Vanderbilt University
    External Chemical And Biomolecular Engineering Advisory Board
    Vanderbilt University 2012 - Present
    Nashville, Tennessee, Us
  • Vanderbilt University
    Industrial Consultant - Chemical And Biomolecular Engineering
    Vanderbilt University 2012 - 2018
    Nashville, Tennessee, Us
  • Bioprocess Technology Consultants, Inc.
    Sr. Consultant
    Bioprocess Technology Consultants, Inc. 2017 - 2019
    BPTC provides an integrated approach to de-risking the technical and regulatory challenges in the development and commercialization of biotechnology/biopharmaceutical products
  • Evonik
    Fermented Products Innovation Management
    Evonik 2015 - 2017
    Essen, Nrw, De
  • Eli Lilly And Company
    Center Of Fermentation Excellence
    Eli Lilly And Company Jul 2012 - 2017
    Indianapolis, Indiana, Us
  • University Of Pennsylvania
    Industrial Consultant Chemical And Biomolecular Engineering
    University Of Pennsylvania Aug 2008 - 2015
    Philadelphia, Pa, Us
  • Pall Life Sciences
    Global Technical And Technology Manager/Leader
    Pall Life Sciences Mar 2010 - 2012
    Port Washington, New York, Us
  • Glaxosmithkline
    Principal Scientist
    Glaxosmithkline 2007 - 2010
    Brentford, Middlesex, Gb

Tiffany Rau Phd Skills

Biopharmaceuticals Fermentation Biotechnology Cell Culture Technology Transfer R&d Manufacturing Gmp Protein Chemistry Design Of Experiments Six Sigma Process Simulation Assay Development Biochemistry Cell Research And Development Cell Biology Laboratory Process Development Cell Line Development International Scientific Development Six Sigma Black Belt Research And Development

Tiffany Rau Phd Education Details

  • Vanderbilt University
    Vanderbilt University
    Chemical Engineering
  • University Of Pennsylvania
    University Of Pennsylvania
    Chemical And Biomolecular Engineering
  • Six Sigma- Master Black Belt
    Six Sigma- Master Black Belt

Frequently Asked Questions about Tiffany Rau Phd

What company does Tiffany Rau Phd work for?

Tiffany Rau Phd works for University College Cork

What is Tiffany Rau Phd's role at the current company?

Tiffany Rau Phd's current role is Process Development to Commercial Manufacturing, CMC, GMP, Biopharma, Cell and Gene Therapy, Facility Design and Start-up, CDMO selection and management, Quality Systems.

What is Tiffany Rau Phd's email address?

Tiffany Rau Phd's email address is ti****@****aol.com

What schools did Tiffany Rau Phd attend?

Tiffany Rau Phd attended Vanderbilt University, University Of Pennsylvania, Six Sigma- Master Black Belt.

What skills is Tiffany Rau Phd known for?

Tiffany Rau Phd has skills like Biopharmaceuticals, Fermentation, Biotechnology, Cell Culture, Technology Transfer, R&d, Manufacturing, Gmp, Protein Chemistry, Design Of Experiments, Six Sigma, Process Simulation.

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